{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2976-s0", "verdict_number": "2976", "title": "Multicomponent digital weight management × Mean weight loss at 12 months", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "351 adults aged 21–65 with obesity at US community health centers, with at least one of hypertension, diabetes or hyperlipidemia. Original randomized denominators: 176 intervention/175 usual care. Detailed eligibility, baseline weight/conditions, visit-specific observations/analyses and attrition/missingness remain unverified.", "intervention": "Multicomponent Track: app-based goal self-monitoring, algorithm-tailored feedback, daily cellular smart-scale weighing, 18 dietitian calls and clinician counseling based on electronic-record recommendations. Stand-alone app/scale/counseling effects cannot be separated. Only the research composition is preserved; no implementation instructions or recommendations are created.", "dose": "Only original planned elements such as 18 counseling calls and daily self-monitoring, and the 12-month evaluation, are preserved. Actual component-specific delivery/use, cumulative contacts, adherence and discontinuation remain unverified; completion by all participants is not assumed.", "comparator": "Parallel comparison with usual care. Actual control management, contact/support, use of other programs, concurrent medication/condition/lifestyle management and crossover use remain unverified. Usual care is not converted into no intervention or contact.", "endpoint": "Standardized measured mean weight change at research visits at 12 months. Intervention −4.0 kg (95% CI −4.9 to −3.0), usual care −0.1 kg (−1.0 to 0.8) and between-group difference −3.8 kg (−5.0 to −2.5), P<0.001, are preserved as separate original estimands. At least 5% weight loss, 40% versus 17% with P<0.001, is a secondary proportion; proportions or event counts are not calculated from means.", "duration": "Study context for 12-month weight/responder outcomes. Visit windows, changes by time point, continuation/discontinuation beyond 12 months and long-term clinical/harm follow-up remain unverified.", "excluded_extensions": [ "Newly subtracting group-specific −4.0/−0.1 kg to recalculate the original between-group difference of −3.8 kg and CI", "Calculating 5% attainment rates, responder events/denominators or individual outcomes from continuous mean change", "Applying 176/175 to 40%/17% to calculate event counts or new differences/RR/OR/NNT/CIs", "Automatically substituting daily smart-scale/app entries for standardized visit measurements or actual adjudication values for secondary proportions", "Repurposing general ITT/prespecified maximum-likelihood narratives as complete verification of responder missingness/denominator rules", "Upgrading the secondary 5% endpoint into a primary endpoint, prespecified success threshold, validated minimum clinically important difference or reductions in blood pressure/glucose/disease events", "Repurposing the app/smart-scale/counseling bundle result as effects of a stand-alone app, individual components or all products/populations", "Using 351 participants, 176/175, groups, time points, components, bibliography/registration or sibling sheets as new independent trial/participant totals", "Judging non-reporting of pivotal-trial support as actual absence, or retrospectively confirming later WW/Coeus disclosures as original-trial relationships", "Creating unlinked low-intensity null trials or later disclosures as new reports, direct refutations or independent replications", "Inheriting original parent values, axes and historical verification as a subclaim score or current content review/registration/original-source reading", "New calculations, invented quantities, effects/CIs, grades, independence certification, app/product recommendations or weight/diet/exercise/weight-loss/treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected mean-weight claim and original grade", "needed": "Distinction between original wording/grade, parent score/axes and responder outcomes", "role": "Required", "role_reason": "An applied item distinguishing distinction between original wording/grade, parent score/axes and responder outcomes to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between original wording/grade, parent score/axes and responder outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study specifying mean change and responder endpoints separately; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected subclaim is “Mean weight loss at 12 months,” with grade C and a note of a −3.8 kg between-group difference. Subclaim score/status/axes are absent; the parent C56 is not used to fill the subclaim score.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score, status and axes are absent. Mean results and reaching the 5% threshold are not combined as one endpoint. Existing content review remains incomplete.", "missingness": "Subclaim score, status and axes are absent. Mean results and reaching the 5% threshold are not combined as one endpoint.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected subclaim and parent verdict, and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Population, obesity and comorbidities", "needed": "Actual eligibility, recruitment, baseline weight/conditions and applicable population", "role": "Required", "role_reason": "An applied item distinguishing actual eligibility, recruitment, baseline weight/conditions and applicable population to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for actual eligibility, recruitment, baseline weight/conditions and applicable population must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The population comprised 351 people aged 21–65 at US community health centers, with obesity and at least one of hypertension, diabetes or hyperlipidemia. Results are not extended to other age or health groups.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Obesity/condition definitions, detailed recruitment/exclusions, baseline weight, distribution of conditions and baseline balance remain unverified. Existing content review remains incomplete.", "missingness": "Obesity/condition definitions, detailed recruitment/exclusions, baseline weight, distribution of conditions and baseline balance remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, recruitment and baseline-characteristics tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Attribution within multicomponent Track", "needed": "Distinction between the bundled program and effects of individual components", "role": "Required", "role_reason": "An applied item distinguishing distinction between the bundled program and effects of individual components to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between the bundled program and effects of individual components must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up comparison distinguishing attribution to a bundle, single components and combinations; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The intervention was Track combining an app, a cellular smart scale, 18 dietitian calls and clinician counseling. Which component produced the mean effect cannot be separated.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent component effects, designs separating components and their relative contributions remain unverified. Existing content review remains incomplete.", "missingness": "Independent component effects, designs separating components and their relative contributions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full intervention manual and component-specific delivery/use records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "App and algorithm roles", "needed": "Actual study identity of app-based goal self-monitoring and tailored feedback", "role": "Required", "role_reason": "An applied item distinguishing actual study identity of app-based goal self-monitoring and tailored feedback to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for actual study identity of app-based goal self-monitoring and tailored feedback must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study distinguishing the app component from counseling and other elements; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that app-based goal self-monitoring and algorithm-tailored feedback were included in the bundle. This is not converted into an effect of a stand-alone app or all digital products.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. App version/algorithm, delivery/access, usage, changes and individual effects remain unverified. Existing content review remains incomplete.", "missingness": "App version/algorithm, delivery/access, usage, changes and individual effects remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Research descriptions and delivery/use records for the app and feedback" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Smart-scale self-monitoring", "needed": "Distinction between the connected scale’s intervention role and outcome measurement", "role": "Required", "role_reason": "An applied item distinguishing distinction between the connected scale’s intervention role and outcome measurement to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between the connected scale’s intervention role and outcome measurement must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study reporting intervention self-monitoring separately from endpoint measurement; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Daily cellular smart-scale weighing was a self-monitoring element of the research intervention. The primary outcome used separate standardized weight measurement at research visits. No new measurement or management instructions are created.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Device/connectivity, actual use, missing records and correspondence between original data and visit measurements remain unverified. Existing content review remains incomplete.", "missingness": "Device/connectivity, actual use, missing records and correspondence between original data and visit measurements remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention-scale records, visit-measurement protocol and data correspondence" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "18 dietitian calls", "needed": "Distinction between counseling plans, actual delivery/use and other contacts", "role": "Required", "role_reason": "An applied item distinguishing distinction between counseling plans, actual delivery/use and other contacts to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between counseling plans, actual delivery/use and other contacts must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing counseling delivery, actual use and component attribution; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "18 dietitian calls were included in the bundled intervention. The planned number is not converted into actual completion by every participant or an effect of counseling alone.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Delivery/use of each call, counseling intensity, missed calls, providers and other contacts remain unverified. Existing content review remains incomplete.", "missingness": "Delivery/use of each call, counseling intensity, missed calls, providers and other contacts remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Telephone-counseling delivery/completion and contact records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Clinician counseling and record integration", "needed": "Research scope of electronic-record recommendations, clinician counseling and concurrent management", "role": "Required", "role_reason": "An applied item distinguishing research scope of electronic-record recommendations, clinician counseling and concurrent management to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for research scope of electronic-record recommendations, clinician counseling and concurrent management must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing attribution to clinical integration and other elements; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Clinician counseling based on electronic-record recommendations was also included. The original interpretation of technology as an adjunct to counseling is retained; no guidance replacing clinical care or treatment is created.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Actual counseling/contact, decisions, concurrent condition/medication management and differences between groups remain unverified. Existing content review remains incomplete.", "missingness": "Actual counseling/contact, decisions, concurrent condition/medication management and differences between groups remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical integration, counseling and concurrent-management records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Usual-care comparison conditions", "needed": "Actual usual-care management/contact and differences between intervention and control", "role": "Required", "role_reason": "An applied item distinguishing actual usual-care management/contact and differences between intervention and control to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for actual usual-care management/contact and differences between intervention and control must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up trial clearly disclosing actual comparison conditions; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original allocation of 176 intervention participants versus 175 receiving usual care is preserved. Usual care is not changed into a group with no management or contact.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Usual-care content, additional control-group support/exposure, crossover use and contact differences remain unverified. Existing content review remains incomplete.", "missingness": "Usual-care content, additional control-group support/exposure, crossover use and contact differences remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Usual-care description and contact/concurrent-exposure records" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "12-month time point and actual exposure", "needed": "Distinction between final 12-month analysis and intervention duration/use", "role": "Required", "role_reason": "An applied item distinguishing distinction between final 12-month analysis and intervention duration/use to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between final 12-month analysis and intervention duration/use must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study distinguishing the final time point from continuation/discontinuation follow-up; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The primary endpoint was weight change at 12 months. Planned intervention components are not equated with actual use, and no effects of continuation or discontinuation beyond 12 months are generated.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Visit windows, actual exposure duration for each component, follow-up beyond 12 months and changes in use remain unverified. Existing content review remains incomplete.", "missingness": "Visit windows, actual exposure duration for each component, follow-up beyond 12 months and changes in use remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedule, component-specific delivery/use and long-term follow-up data" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Random sequence and allocation concealment", "needed": "Original allocation-procedure narrative and scope of actual source verification", "role": "Required", "role_reason": "An applied item distinguishing original allocation-procedure narrative and scope of actual source verification to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for original allocation-procedure narrative and scope of actual source verification must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that a statistician generated the random sequence and concealed it from study staff until assignment. This is a historical procedure narrative in the preserved summary, not current original-source review or certification.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Allocation records, implementation, exceptions and correspondence with the original protocol/registration remain unread. Existing content review remains incomplete.", "missingness": "Allocation records, implementation, exceptions and correspondence with the original protocol/registration remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation/concealment text, protocol and baseline tables" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Masked outcome assessors and unmasked participants", "needed": "Distinction between assessor masking and intervention characteristics", "role": "Required", "role_reason": "An applied item distinguishing distinction between assessor masking and intervention characteristics to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between assessor masking and intervention characteristics must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing assessor masking from participant expectation effects; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that outcome-measurement staff were masked to allocation, while participants could not be masked because of the intervention. The historical B0 narrative is not used as current verification of all masking.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Original data on assessor/analyst roles, maintenance/breaking of masking and expectation effects remain unread. Existing content review remains incomplete.", "missingness": "Original data on assessor/analyst roles, maintenance/breaking of masking and expectation effects remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking roles, measurement procedures and original materials" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Standardized measurements and weight-change definition", "needed": "Visit measurements, change from baseline, units and measurement windows", "role": "Required", "role_reason": "An applied item distinguishing visit measurements, change from baseline, units and measurement windows to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for visit measurements, change from baseline, units and measurement windows must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study reporting measured outcomes separately from remote self-monitoring; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The primary endpoint was standardized measured weight change at research visits at 12 months. App entries, self-reports and daily smart-scale logs are not used as the same endpoint.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Details of baseline/visit measurements, equipment/calibration, conditions, measurement windows and handling of repeats remain unverified. Existing content review remains incomplete.", "missingness": "Details of baseline/visit measurements, equipment/calibration, conditions, measurement windows and handling of repeats remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Standardized weight measurement, baseline/visit tables and calculation definitions" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Group-specific mean changes and CIs", "needed": "Separate estimands for changes within each group and the between-group effect", "role": "Required", "role_reason": "An applied item distinguishing separate estimands for changes within each group and the between-group effect to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for separate estimands for changes within each group and the between-group effect must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study reporting group changes and the between-group estimate distinctly together; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original values are preserved: intervention −4.0 kg (95% CI −4.9 to −3.0) and usual care −0.1 kg (−1.0 to 0.8). Rounded group values are not newly subtracted or converted into final absolute weights.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Group-specific baseline/final absolute values, model/adjustment details for each estimate and individual distributions remain unverified. Existing content review remains incomplete.", "missingness": "Group-specific baseline/final absolute values, model/adjustment details for each estimate and individual distributions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group values, change estimates and model descriptions" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Between-group difference of −3.8 kg", "needed": "Exact original 12-month between-group difference, CI and P value", "role": "Required", "role_reason": "An applied item distinguishing exact original 12-month between-group difference, CI and P value to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for exact original 12-month between-group difference, CI and P value must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study disclosing the primary effect estimate and uncertainty; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The between-group difference was −3.8 kg (95% CI −5.0 to −2.5), P<0.001. The original estimate is preserved; no new difference/CI, standardized effect or relative weight-loss rate is calculated.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Exact model terms, adjustment/baseline correspondence and data for reproducing estimates remain unread. Existing content review remains incomplete.", "missingness": "Exact model terms, adjustment/baseline correspondence and data for reproducing estimates remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original between-group contrast, model and CI results" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Mean, individual response and the 5% threshold", "needed": "Distinction between continuous mean change and the secondary responder endpoint", "role": "Required", "role_reason": "An applied item distinguishing distinction between continuous mean change and the secondary responder endpoint to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between continuous mean change and the secondary responder endpoint must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up trial distinguishing mean and prespecified responder outcomes; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "At least 5% weight loss, 40% versus 17% with P<0.001, was a separate secondary responder result. Threshold attainment or event counts are not calculated from mean values of −4.0/−0.1 or −3.8 kg.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Individual baseline/change distributions, threshold calculation, responder denominators/event counts and CIs remain unverified. Existing content review remains incomplete.", "missingness": "Individual baseline/change distributions, threshold calculation, responder denominators/event counts and CIs remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Responder definitions, denominators/events and individual-result data" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "351 participants, 176/175 and denominators", "needed": "Randomized population and endpoint-specific analysis/measurement denominators", "role": "Required", "role_reason": "An applied item distinguishing randomized population and endpoint-specific analysis/measurement denominators to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for randomized population and endpoint-specific analysis/measurement denominators must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study distinguishing randomized, observed and estimated denominators; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "351 randomized participants (176/175) are preserved as recorded. Enrollment is not used to imply measurement of every participant at 12 months or the observed denominator for every analysis.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. 12-month measurement, model-analysis, group-specific visit/response denominators and analysis-inclusion criteria remain unverified. Existing content review remains incomplete.", "missingness": "12-month measurement, model-analysis, group-specific visit/response denominators and analysis-inclusion criteria remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and visit-specific measured/analysis denominators" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "ITT principle and estimand population", "needed": "ITT narrative and outcome-specific analysis conditions", "role": "Required", "role_reason": "An applied item distinguishing iTT narrative and outcome-specific analysis conditions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for iTT narrative and outcome-specific analysis conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study disclosing ITT separately from other analyses; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records following the ITT principle. This historical narrative is not used to establish analysis-population details, completeness of all observations or current content-review verification.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Primary-effect inclusion criteria, estimand-population definitions, analysis exceptions and original PPS/sensitivity results remain unread. Existing content review remains incomplete.", "missingness": "Primary-effect inclusion criteria, estimand-population definitions, analysis exceptions and original PPS/sensitivity results remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ITT definition, inclusion/exclusion, model and sensitivity materials" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Missing data and maximum-likelihood model", "needed": "Distinction between missing-data narratives, missingness/attrition and model assumptions", "role": "Required", "role_reason": "An applied item distinguishing distinction between missing-data narratives, missingness/attrition and model assumptions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between missing-data narratives, missingness/attrition and model assumptions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing observations from estimates when reporting missing-data effects; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that missing observations were estimated by maximum likelihood in the prespecified model. This is not changed into measurement of all participants or absence of missing-data effects.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Group-specific reasons/timing of missingness/attrition, model terms/assumptions, sensitivity to non-random missingness and actual numbers remain unverified. Existing content review remains incomplete.", "missingness": "Group-specific reasons/timing of missingness/attrition, model terms/assumptions, sensitivity to non-random missingness and actual numbers remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow, missing-data handling and model-assumption/sensitivity materials" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Registration and prespecified primary endpoint", "needed": "Preserved scope of the NCT identifier, advance dates and endpoint plan", "role": "Required", "role_reason": "An applied item distinguishing preserved scope of the NCT identifier, advance dates and endpoint plan to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for preserved scope of the NCT identifier, advance dates and endpoint plan must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study openly linking advance plans and actual primary analysis; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original records of NCT01827800, posting on 2013-04-10 and allocation starting on 2013-06-18 are preserved. The narrative that these matched the primary 12-month weight-change endpoint is historical; full registration/plans remain unread in this work.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Registration changes, protocol/SAP, the complete pre-recruitment analysis conditions and original-source correspondence remain unread. Existing content review remains incomplete.", "missingness": "Registration changes, protocol/SAP, the complete pre-recruitment analysis conditions and original-source correspondence remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol, and SAP" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Multiple outcomes, time points and hierarchy", "needed": "Advance hierarchy of the primary mean endpoint, responders and other outcomes", "role": "Required", "role_reason": "An applied item distinguishing advance hierarchy of the primary mean endpoint, responders and other outcomes to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for advance hierarchy of the primary mean endpoint, responders and other outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing the primary endpoint from secondary results; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript’s primary mean weight endpoint at 12 months is distinguished from the secondary 5% responder result. Reductions in blood pressure, glucose or disease events, or primary effects at other time points, are not generated.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. The complete outcomes/time points, multiplicity adjustment, analysis/reporting changes and secondary-result tables remain unverified. Existing content review remains incomplete.", "missingness": "The complete outcomes/time points, multiplicity adjustment, analysis/reporting changes and secondary-result tables remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, complete results and hierarchy/multiplicity materials" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Concurrent management, medication and lifestyle", "needed": "Group-specific effects of conditions/medication, diet/activity and clinical contact", "role": "Required", "role_reason": "An applied item distinguishing group-specific effects of conditions/medication, diet/activity and clinical contact to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for group-specific effects of conditions/medication, diet/activity and clinical contact must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study distinguishing concurrent management from intervention components; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This was a bundled study involving comorbidities and clinician counseling. It does not establish that concurrent management, medication or lifestyle beyond the app, scale and counseling were equal or had no effect.", "condition_status": "Unverified", "status_reason": "Information currently needed is unverified in the preserved summary. Details of concurrent management/medication changes, diet/activity, group-specific exposure and handling of differences remain unverified. Existing content review remains incomplete.", "missingness": "Details of concurrent management/medication changes, diet/activity, group-specific exposure and handling of differences remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent-exposure, condition/medication and lifestyle records and analyses" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Weight, clinical events and importance", "needed": "Distinction between weight change, clinical events and success/importance criteria", "role": "Required", "role_reason": "An applied item distinguishing distinction between weight change, clinical events and success/importance criteria to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between weight change, clinical events and success/importance criteria must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing weight from clinical outcomes important to patients; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original verdict distinguishes weight from actual events such as disease onset or death. The manuscript’s statement that no prespecified success threshold or externally validated minimum clinically important difference was declared is preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Declared clinical-importance/success criteria, disease events and long-term functional effects remain unverified. Existing content review remains incomplete.", "missingness": "Declared clinical-importance/success criteria, disease events and long-term functional effects remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified importance criteria and clinical-outcome/follow-up materials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "NIH public funding", "needed": "Distinction between actual funder/grant and other support categories", "role": "Required", "role_reason": "An applied item distinguishing distinction between actual funder/grant and other support categories to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between actual funder/grant and other support categories must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up trial disclosing support roles; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "NIH NIDDK support through R01DK093829 is preserved as recorded. Public funding is not converted into absence of all support/author relationships or new independence certification.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Funder roles, agreements, data/publication decisions and complete original support statements remain unread. Existing content review remains incomplete.", "missingness": "Funder roles, agreements, data/publication decisions and complete original support statements remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding disclosures, support roles and agreements" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Commercial, scale, analysis/writing/publication support", "needed": "Scope of category-specific non-reporting in the pivotal paper", "role": "Required", "role_reason": "An applied item distinguishing scope of category-specific non-reporting in the pivotal paper to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for scope of category-specific non-reporting in the pivotal paper must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study disclosing support categories separately; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript states that the pivotal paper did not report commercial sponsorship, donated scales, outsourced analysis, medical writing or publication-fee support. Non-reporting is not judged as actual absence.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Each support category, actual agreements, complete originals and research roles remain unread. Existing content review remains incomplete.", "missingness": "Each support category, actual agreements, complete originals and research roles remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Disclosures of commercial/in-kind, outsourced-analysis and writing/publication support" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Later author relationships and historical attribution", "needed": "Timing, individuals and relation of later disclosures to the original trial", "role": "Required", "role_reason": "An applied item distinguishing timing, individuals and relation of later disclosures to the original trial to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for timing, individuals and relation of later disclosures to the original trial must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap’s custom independence/attribution conditions. The official methodology sections used in this pilot do not guarantee all these detailed items; M04 §4.5, §4.6.3; current conversion limits reflect review scope and custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study reporting support and author relationships separately by period; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records a later paper disclosing Gary Bennett’s WW scientific-adviser role and equity in Coeus Health. A later disclosure after the pivotal trial is not applied retrospectively as confirmation of funding or roles during that trial.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific later bibliography/disclosure dates, contemporaneous agreements, relationships during the original trial and complete COI remain unlinked/unread. Existing content review remains incomplete.", "missingness": "Specific later bibliography/disclosure dates, contemporaneous agreements, relationships during the original trial and complete COI remain unlinked/unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Later original disclosures, dates and materials relating them to original-trial COI" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Other low-intensity null trials and applicability differences", "needed": "Distinction between references to null programs and direct Track comparisons", "role": "Required", "role_reason": "An applied item distinguishing distinction between references to null programs and direct Track comparisons to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between references to null programs and direct Track comparisons must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study matching composition and intensity for comparison; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Null trials of app-only or low-intensity technology support are mentioned, but the original explanation treats them as generalization limits rather than direct refutations of Track because composition and intensity differ. Unlinked reports are not created as new trials.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific bibliography, population/intervention/denominators, endpoints and results of the other trials are not linked. Existing content review remains incomplete.", "missingness": "Specific bibliography, population/intervention/denominators, endpoints and results of the other trials are not linked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparison-program originals and relationships in composition/intensity/endpoints" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Same report, sibling sheets and independent replication", "needed": "Report-to-trial-to-group/time-point/denominator relationships", "role": "Required", "role_reason": "An applied item distinguishing report-to-trial-to-group/time-point/denominator relationships to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for report-to-trial-to-group/time-point/denominator relationships must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed independent follow-up comparison of the same bundle/endpoint; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The mean and 5% sheets share the same Bennett2018 Track report of 351 randomized participants. Groups, time points, app/counseling components, bibliography/registration and sibling sheets are not added as new independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent reproduction with the same composition/endpoint and unique trial/participant totals are not established. Existing content review remains incomplete.", "missingness": "Independent reproduction with the same composition/endpoint and unique trial/participant totals are not established.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/cohort relationships and originals of separate independent studies" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Persistence and generalization across products/populations", "needed": "12-month bundle results versus later effects or other programs", "role": "Required", "role_reason": "An applied item distinguishing 12-month bundle results versus later effects or other programs to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for 12-month bundle results versus later effects or other programs must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4; internal extension boundaries", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study distinguishing applicability by bundle, population and duration; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Results are limited to the population and duration of the Track bundle including counseling. They are not extended to all apps/commercial products, other populations, persistence beyond 12 months or disease-treatment effects.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Long-term/discontinuation follow-up, other populations/compositions and direct single-component comparisons remain unverified. Existing content review remains incomplete.", "missingness": "Long-term/discontinuation follow-up, other populations/compositions and direct single-component comparisons remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up and direct trials by population/composition" }, { "item_id": "N29", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Original safety record and reporting gaps", "needed": "Prespecification, collection and group-specific denominators/follow-up for adverse events", "role": "Supplementary", "role_reason": "An applied item distinguishing prespecification, collection and group-specific denominators/follow-up for adverse events to connect the selected question’s needed materials with current materials.", "application_exception": "Supplements safety-data gaps for the selected subclaim. Mean weight, 5% responder results and parent caution wording are not used to judge safety or generate harm incidence or new use instructions.", "criterion": "Corresponding original materials and analysis scope for prespecification, collection and group-specific denominators/follow-up for adverse events must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study specifying harm collection and population-specific follow-up; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent safety is unknown, and the manuscript states that the pivotal paper did not systematically present adverse events as a prespecified safety endpoint. Mean weight loss is not used as absence of harm or safety of disease management.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Adverse-event collection/adjudication, group-specific frequencies/denominators, discontinuation and long-term/vulnerable-population harms remain unverified. Existing content review remains incomplete.", "missingness": "Adverse-event collection/adjudication, group-specific frequencies/denominators, discontinuation and long-term/vulnerable-population harms remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety plans, adverse-event tables and discontinuation/long-term follow-up" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Parent/subclaim, Korean/English, dates and history", "needed": "Separation of original values/axes from corrections and historical verification narratives", "role": "Required", "role_reason": "An applied item distinguishing separation of original values/axes from corrections and historical verification narratives to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for separation of original values/axes from corrections and historical verification narratives must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed study distinguishing original values/history from the applicability of later updates; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent C56, B/S/R1/I2/E+/B0, unrecorded precision, three false flags, empty override reasons and subclaim grade C/note are preserved. Korean/English text, 2026-08-26, empty corrections/deliberation and historical cross-checking are not current review or a subclaim score.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification. Existing content review remains incomplete.", "missingness": "Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original corrections, versions and user correction comments" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Actual summary reading and external links", "needed": "Reading the preserved JSON versus access to external originals, registration, plans and COI", "role": "Required", "role_reason": "An applied item distinguishing reading the preserved JSON versus access to external originals, registration, plans and COI to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for reading the preserved JSON versus access to external originals, registration, plans and COI must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up study updating acquisition, timing and scope separately; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The full preserved JSON summary and bibliography were used for production, and links are retained. Papers, registration, protocol, SAP and original later disclosures/support materials remain unread with no access attempt; links were not tested.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. External-source contents, exact denominators/models and actual accessibility remain unverified. Existing content review remains incomplete.", "missingness": "External-source contents, exact denominators/models and actual accessibility remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Originals, registration, protocol, SAP, support/COI materials or user comments" } ], "reports": [ { "report_id": "S01", "title": "Bennett GG et al. 2018 Track", "url": "https://pubmed.ncbi.nlm.nih.gov/30361140/", "report_type": "Community-health-center randomized usual-care-controlled effectiveness trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2976-TRACK-2018", "independent_replication": null, "observed_result": "−4.0 kg versus −0.1 kg; between-group difference −3.8 kg (95% CI −5.0 to −2.5), P<0.001. At least 5% weight loss was 40% versus 17%, P<0.001, but this was a secondary responder criterion rather than the primary endpoint. Null trials of app-only or low-intensity technology support are also noted; this result is limited to the Track bundle including counseling.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30361140/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Bennett2018 Track is one 12-month parallel report comparing bundled Track with usual care in 351 adults (176/175) aged 21–65 with obesity and at least one of hypertension/diabetes/hyperlipidemia at US community health centers. Individual effects of the app, cellular smart scale, 18 dietitian calls and clinician counseling cannot be separated. The two sheets share the same people/report. Standardized research-visit mean changes of −4.0 kg (95% CI −4.9 to −3.0) versus −0.1 kg (−1.0 to 0.8), and between-group difference −3.8 kg (−5.0 to −2.5), P<0.001, are primary continuous results. At least 5% weight loss, 40% versus 17%, P<0.001, is a secondary responder result; proportions or event counts are not calculated from means. Registration, ITT/maximum likelihood, public funding and later author disclosures are preserved historical narratives, not current external reading/content review. Specific bibliographies for other low-intensity null trials and later disclosures are unlinked, so no new report is created. Groups, time points, thresholds, bibliography/registration and sibling sheets are not added as new independent trials or participants; report-item counts are not unique clinical totals." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }