# Multicomponent digital weight management × At least 5% weight loss Verdict 2976 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-14 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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. - Ingredient, formulation and route: 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. - Measured outcome: At least 5% weight loss in 40% versus 17%, P<0.001, is a secondary responder result. Reference values/measurements for threshold calculation, exact denominators/events, proportion models, CIs and missing-data handling remain unverified. Attainment rates or event counts are not calculated from primary mean change or the between-group difference, and 5% is not upgraded into a prespecified success threshold or reduced clinical events. - 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. - Questions outside this scope: 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 ## Checklist items ### N01 · Selected 5% claim and original grade Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The selected subclaim is “At least 5% weight loss,” with grade C and a note of a secondary responder result of 40% versus 17%. Subclaim score/status/axes are absent; parent C56 is not used to fill the subclaim score. - Why unverified: 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. The primary mean endpoint and secondary responder endpoint are not combined. Existing content review remains incomplete. - Reason for missing information: Subclaim score, status and axes are absent. The primary mean endpoint and secondary responder endpoint are not combined. - Required materials and conditions: Distinction between the original responder question/grade and the parent mean-weight verdict - Materials to obtain first: Original selected subclaim and parent verdict, and user correction comments - Further research: A proposed follow-up comparison specifying the responder question and hierarchy; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between the original responder question/grade and the parent mean-weight verdict must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between the original responder question/grade and the parent mean-weight verdict to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N02 · Definition of the 5% threshold Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original question concerns attaining the threshold of at least 5% weight loss. This is not converted into mean change in kg, individual final weight or change in every participant. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Reference weight/calculation formula, rounding/boundaries, evaluation windows, measurement selection and details of advance definitions remain unverified. Existing content review remains incomplete. - Reason for missing information: Reference weight/calculation formula, rounding/boundaries, evaluation windows, measurement selection and details of advance definitions remain unverified. - Required materials and conditions: Threshold, reference weight, calculation/time point and responder-adjudication rules - Materials to obtain first: Responder definitions, baseline/final measurements and adjudication rules - Further research: A proposed follow-up study specifying thresholds, measurement and time points; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for threshold, reference weight, calculation/time point and responder-adjudication rules must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing threshold, reference weight, calculation/time point and responder-adjudication rules to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application - Related sources: S01 ### N03 · 40% versus 17% and P value Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original result was at least 5% weight loss in 40% versus 17%, P<0.001. No new proportion difference, RR/OR, NNT, CI or event count is calculated. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Analysis denominators/event counts for each proportion, exact test/model, CI and distinction between observed/estimated values remain unverified. Existing content review remains incomplete. - Reason for missing information: Analysis denominators/event counts for each proportion, exact test/model, CI and distinction between observed/estimated values remain unverified. - Required materials and conditions: Distinction between original proportions, group correspondence, P value and new arithmetic - Materials to obtain first: Responder-result tables and original denominator/event/effect/CI data - Further research: A proposed study reporting proportions together with uncertainty and denominators; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between original proportions, group correspondence, P value and new arithmetic must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between original proportions, group correspondence, P value and new arithmetic to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation - Related sources: S01 ### N04 · Responder denominators and event counts Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 351 randomized participants (176/175) describe the original population. These are not multiplied by 40%/17% to create event counts or used to fill the effective denominator of each proportion. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Effective denominators for each proportion, responder counts, inclusion/exclusion and measured/estimated criteria remain unverified. Existing content review remains incomplete. - Reason for missing information: Effective denominators for each proportion, responder counts, inclusion/exclusion and measured/estimated criteria remain unverified. - Required materials and conditions: Randomized, observed and model denominators and actual responder counts - Materials to obtain first: Responder denominators/events, participant flow and analysis-population data - Further research: A proposed study reporting enrolled, observed and estimated denominators separately; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for randomized, observed and model denominators and actual responder counts must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing randomized, observed and model denominators and actual responder counts to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N05 · Proportion effects, CIs and precision Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Original proportions and P value are preserved. Proportion differences, relative effects, CIs or individual success probabilities unlinked in the manuscript are not newly created. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Planned effect measures, exact estimates, CIs and importance/success criteria remain unverified. Existing content review remains incomplete. - Reason for missing information: Planned effect measures, exact estimates, CIs and importance/success criteria remain unverified. - Required materials and conditions: Original proportions, prespecified effect measures, CIs and clinical importance - Materials to obtain first: Original proportion-effect/CI data and prespecified importance criteria - Further research: A proposed follow-up study disclosing effect measures and uncertainty; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for original proportions, prespecified effect measures, CIs and clinical importance must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing original proportions, prespecified effect measures, CIs and clinical importance to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; custom application - Related sources: S01 ### N06 · Mean change is a different endpoint Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Mean change of −4.0 kg versus −0.1 kg and a between-group difference of −3.8 kg (95% CI −5.0 to −2.5), P<0.001, form a separate primary endpoint. The 5% proportions, event counts or individual weight loss are not calculated from these. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Individual baseline/change distributions and data linking mean and responder outcomes remain unverified. Existing content review remains incomplete. - Reason for missing information: Individual baseline/change distributions and data linking mean and responder outcomes remain unverified. - Required materials and conditions: Distinction between continuous means and threshold-attainment distributions/proportions - Materials to obtain first: Individual/group distributions and results for each endpoint - Further research: A proposed follow-up trial distinguishing mean and responder endpoints; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between continuous means and threshold-attainment distributions/proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between continuous means and threshold-attainment distributions/proportions to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N07 · Secondary endpoint and prespecified hierarchy Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript identifies at least 5% weight loss as a secondary responder result. This is not upgraded into a new primary endpoint, independent confirmatory trial or prespecified success threshold. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Pre-recruitment specification of responder definitions/analyses, test order, change history and estimation models remain unverified. Existing content review remains incomplete. - Reason for missing information: Pre-recruitment specification of responder definitions/analyses, test order, change history and estimation models remain unverified. - Required materials and conditions: Distinction between the primary mean endpoint and secondary 5% responder result - Materials to obtain first: Responder hierarchy/plans in registration, protocol and SAP - Further research: A proposed study distinguishing the primary endpoint from prespecified responder analyses; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between the primary mean endpoint and secondary 5% responder result must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between the primary mean endpoint and secondary 5% responder result to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application - Related sources: S01 ### N08 · Measured weight and responder-adjudication values Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Primary weight change used standardized measurement at research visits. This is distinguished from daily smart-scale/app entries and self-report; actual values/visit rules used for the 5% proportions are not filled in. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Measurement sources, evaluation windows, equipment/conditions and valid baseline/final values for responder adjudication remain unverified. Existing content review remains incomplete. - Reason for missing information: Measurement sources, evaluation windows, equipment/conditions and valid baseline/final values for responder adjudication remain unverified. - Required materials and conditions: Correspondence between visit weight, self-monitoring/self-report and proportion calculations - Materials to obtain first: Responder adjudication/measurement protocols and original weight data - Further research: A proposed study linking measured/remote measurements with responder calculations; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for correspondence between visit weight, self-monitoring/self-report and proportion calculations must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing correspondence between visit weight, self-monitoring/self-report and proportion calculations to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N09 · Population, comorbidities and recruitment Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 351 people aged 21–65 at community health centers had obesity and at least one of hypertension, diabetes or hyperlipidemia. This is not extended into the probability of attaining 5% loss in other populations. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline weight/condition distributions, recruitment/exclusions and group balance remain unverified. Existing content review remains incomplete. - Reason for missing information: Detailed eligibility, baseline weight/condition distributions, recruitment/exclusions and group balance remain unverified. - Required materials and conditions: Obese population aged 21–65 with baseline conditions and applicability scope - Materials to obtain first: Eligibility, baseline-characteristics and recruitment tables - Further research: A proposed follow-up study specifying applicability by population; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for obese population aged 21–65 with baseline conditions and applicability scope must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing obese population aged 21–65 with baseline conditions and applicability scope to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N10 · Attribution within multicomponent Track Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The intervention bundled an app, cellular smart scale, 18 dietitian calls and clinician counseling. The proportion attaining 5% loss is not converted into an effect of a stand-alone app or a specific component. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent component effects, component-separation/combination designs and contributions of actual use remain unverified. Existing content review remains incomplete. - Reason for missing information: Independent component effects, component-separation/combination designs and contributions of actual use remain unverified. - Required materials and conditions: The full bundle versus individual effects of app/counseling and other components - Materials to obtain first: Full intervention composition, delivery/use and component-separation designs - Further research: A proposed follow-up comparison distinguishing bundle and component attribution; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for the full bundle versus individual effects of app/counseling and other components must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing the full bundle versus individual effects of app/counseling and other components to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N11 · Component plans and actual use Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records app self-monitoring/tailored feedback, daily cellular-scale weighing, 18 calls and counseling based on electronic-record recommendations. Plans are not used to imply actual completion by every participant. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Component-specific delivery/usage, adherence, discontinuation, contact intensity and differences in clinical/concurrent management remain unverified. Existing content review remains incomplete. - Reason for missing information: Component-specific delivery/usage, adherence, discontinuation, contact intensity and differences in clinical/concurrent management remain unverified. - Required materials and conditions: Delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration - Materials to obtain first: Delivery, use and contact records for the app/device/counseling/clinical care - Further research: A proposed follow-up study distinguishing plans from actual exposure and response; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N12 · Usual-care control Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The comparison involved 176 intervention participants versus 175 receiving usual care. Usual care is not described as no management/contact, and equal support in all respects is not established. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Control content, contact/support, additional programs, crossover use and baseline-condition management remain unverified. Existing content review remains incomplete. - Reason for missing information: Control content, contact/support, additional programs, crossover use and baseline-condition management remain unverified. - Required materials and conditions: Actual control management, contact and additional-exposure conditions - Materials to obtain first: Usual-care and concurrent-exposure/contact records - Further research: Proposed follow-up trial disclosing actual comparison conditions; no new investigation, calculation or trial was performed in this production. - Conditions for verification: Corresponding original materials and analysis scope for actual control management, contact and additional-exposure conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing actual control management, contact and additional-exposure conditions to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N13 · 12-month assessment, maintenance and regain Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The responder result in the 12-month study context is preserved. Attaining the threshold once during follow-up, sustained attainment and maintenance/regain beyond 12 months are not made into the same outcome. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Exact evaluation windows, earlier responses, maintained attainment/regain and long-term/discontinuation follow-up remain unverified. Existing content review remains incomplete. - Reason for missing information: Exact evaluation windows, earlier responses, maintained attainment/regain and long-term/discontinuation follow-up remain unverified. - Required materials and conditions: Distinction between the selected responder time point and persistence during or beyond follow-up - Materials to obtain first: Responder visit/time-point definitions and long-term follow-up materials - Further research: A proposed study reporting threshold attainment separately from maintenance/regain; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between the selected responder time point and persistence during or beyond follow-up must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between the selected responder time point and persistence during or beyond follow-up to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed - Related sources: S01 ### N14 · Randomization and allocation concealment Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records sequence generation by a statistician and concealment from study staff before allocation. It is not described as current original-source review or verification of allocation records. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Allocation records, implementation/exceptions, baseline balance and correspondence with the original protocol remain unread. Existing content review remains incomplete. - Reason for missing information: Allocation records, implementation/exceptions, baseline balance and correspondence with the original protocol remain unread. - Required materials and conditions: Historical allocation-procedure narrative and current access to originals - Materials to obtain first: Original allocation/concealment, baseline and protocol materials - Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production. - Conditions for verification: Corresponding original materials and analysis scope for historical allocation-procedure narrative and current access to originals must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing historical allocation-procedure narrative and current access to originals to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N15 · Assessor masking and participant expectations Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records masked measurement staff and unmasked participants. This is not extended into verification of every responder-calculation/analysis role or exclusion of expectation effects. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Original materials on responder-adjudication/analysis roles, maintained masking and expectation/behavior effects remain unread. Existing content review remains incomplete. - Reason for missing information: Original materials on responder-adjudication/analysis roles, maintained masking and expectation/behavior effects remain unread. - Required materials and conditions: Scope of masking for outcome assessors and participants - Materials to obtain first: Masking-role materials for measurement, adjudication and analysis - Further research: A proposed study distinguishing masking from participant behavior/expectation scope; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for scope of masking for outcome assessors and participants must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing scope of masking for outcome assessors and participants to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N16 · ITT and responder-analysis population Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript’s statement of following ITT is preserved. It is not automatically transferred into details of populations/handling used for the 5% proportions or verification of observation of all participants. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Responder-analysis inclusion/exclusion, actual population definitions, primary/sensitivity analyses and PPS correspondence remain unverified. Existing content review remains incomplete. - Reason for missing information: Responder-analysis inclusion/exclusion, actual population definitions, primary/sensitivity analyses and PPS correspondence remain unverified. - Required materials and conditions: Overall ITT principle versus actual denominators/populations for secondary proportions - Materials to obtain first: Original responder-analysis populations, ITT application and sensitivity materials - Further research: A proposed study separately disclosing analysis populations for continuous and responder outcomes; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for overall ITT principle versus actual denominators/populations for secondary proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing overall ITT principle versus actual denominators/populations for secondary proportions to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house. - Related sources: S01 ### N17 · Maximum-likelihood missing data and proportion handling Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript’s prespecified-model maximum-likelihood estimation is preserved. This is not used as identical verification of missing-data handling or denominator rules for responder proportions. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Missing-data adjudication, imputation/estimation, nonresponse handling and model/sensitivity for the 5% result remain unverified. Existing content review remains incomplete. - Reason for missing information: Missing-data adjudication, imputation/estimation, nonresponse handling and model/sensitivity for the 5% result remain unverified. - Required materials and conditions: Distinction between primary-analysis missing-data estimation and handling of unobserved responders - Materials to obtain first: Continuous/responder missing-data handling, models and sensitivity materials - Further research: A proposed study reporting endpoint-specific missing-data handling and effects separately; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between primary-analysis missing-data estimation and handling of unobserved responders must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between primary-analysis missing-data estimation and handling of unobserved responders to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N18 · Attrition, non-observation and missed visits Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: 351 participants and 176/175 describe the randomized population. Without distinguishing observed/unobserved measurements and participant attrition, these are not used as outcomes for everyone or absence of missing-data effects. - Why unverified: Information currently needed is unverified in the preserved summary. Visit/group-specific observed counts, attrition causes, response-related missingness and follow-up status remain unverified. Existing content review remains incomplete. - Reason for missing information: Visit/group-specific observed counts, attrition causes, response-related missingness and follow-up status remain unverified. - Required materials and conditions: Group-specific timing, causes and response effects of attrition/missingness - Materials to obtain first: Flow diagrams, visit/group denominators and attrition/follow-up materials - Further research: A proposed follow-up study disclosing effects of non-observation and response adjudication; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for group-specific timing, causes and response effects of attrition/missingness must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing group-specific timing, causes and response effects of attrition/missingness to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N19 · Proportion tests, within/between groups and adjustment Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The group correspondence of 40% versus 17% and P<0.001 is preserved as recorded. Within-group changes or rounded proportions are not converted into new adjusted effects or event risk ratios. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Exact tests, models/covariates, observed/estimated proportions, adjustment/advance plans and CIs remain unverified. Existing content review remains incomplete. - Reason for missing information: Exact tests, models/covariates, observed/estimated proportions, adjustment/advance plans and CIs remain unverified. - Required materials and conditions: Proportion contrasts and original model, test and adjustment conditions - Materials to obtain first: Original proportion-analysis models, contrasts, adjustments and CIs - Further research: A proposed study clearly reporting proportion estimands and tests; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for proportion contrasts and original model, test and adjustment conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing proportion contrasts and original model, test and adjustment conditions to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application - Related sources: S01 ### N20 · Registration and advance responder plans Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Original NCT01827800, posting on 2013-04-10 and allocation starting on 2013-06-18 are preserved. Prospective registration and agreement with the primary 12-month mean endpoint do not substitute for verification of all 5% analysis conditions. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Secondary responder plans/definitions, pre-recruitment SAP, change history and full registration remain unread. Existing content review remains incomplete. - Reason for missing information: Secondary responder plans/definitions, pre-recruitment SAP, change history and full registration remain unread. - Required materials and conditions: NCT identifier and scope of advance plans for primary/secondary proportion endpoints - Materials to obtain first: Responder plans in registration history, protocol and SAP - Further research: A proposed study openly linking registration with actual secondary analyses; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for nCT identifier and scope of advance plans for primary/secondary proportion endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing nCT identifier and scope of advance plans for primary/secondary proportion endpoints to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N21 · Multiple outcomes, hierarchy and time points Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 5% is a secondary outcome distinct from mean weight. Success at multiple time points, blood-pressure/glucose/other outcomes or independent replication is not newly created. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Complete lists of secondary outcomes/time points, adjustment, hierarchy and analysis/reporting changes remain unverified. Existing content review remains incomplete. - Reason for missing information: Complete lists of secondary outcomes/time points, adjustment, hierarchy and analysis/reporting changes remain unverified. - Required materials and conditions: Multiplicity in testing responders and other time points/endpoints - Materials to obtain first: Complete results, SAP and hierarchy/multiplicity materials - Further research: A proposed study separating primary endpoints from secondary proportions and other outcomes; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for multiplicity in testing responders and other time points/endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing multiplicity in testing responders and other time points/endpoints to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed - Related sources: S01 ### N22 · Thresholds, importance and disease events Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records no declared prespecified success threshold or externally validated minimum clinically important difference. The secondary 5% threshold is not repurposed as a trial-success boundary or reductions in blood pressure/glucose/disease events. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Evidence for threshold importance, advance success definitions and patient-important clinical/long-term outcomes remain unverified. Existing content review remains incomplete. - Reason for missing information: Evidence for threshold importance, advance success definitions and patient-important clinical/long-term outcomes remain unverified. - Required materials and conditions: Distinction between 5% response, advance success/importance criteria and clinical outcomes - Materials to obtain first: Threshold/importance criteria and clinical-outcome/follow-up materials - Further research: A proposed follow-up study distinguishing responders from clinical outcomes; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between 5% response, advance success/importance criteria and clinical outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between 5% response, advance success/importance criteria and clinical outcomes to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M04 §4.6.3; custom application - Related sources: S01 ### N23 · Concurrent management, medication and lifestyle Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: This bundled trial involved baseline conditions and clinician counseling. Absence of medication/diet/activity/contact differences or effects on attaining 5% loss is not assumed. - Why unverified: Information currently needed is unverified in the preserved summary. Group-specific concurrent management/medication changes, lifestyle, additional support and their analyses remain unverified. Existing content review remains incomplete. - Reason for missing information: Group-specific concurrent management/medication changes, lifestyle, additional support and their analyses remain unverified. - Required materials and conditions: Concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes - Materials to obtain first: Concurrent-exposure, lifestyle/condition-management and analysis materials - Further research: A proposed follow-up study distinguishing concurrent management from responder outcomes; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N24 · NIH public support Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: NIH NIDDK R01DK093829 provided support. This is not used as absence of all commercial/author relationships or new independence certification. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Funder/researcher roles, agreements, data/publication rights and complete disclosures remain unread. Existing content review remains incomplete. - Reason for missing information: Funder/researcher roles, agreements, data/publication rights and complete disclosures remain unread. - Required materials and conditions: Distinction between funder/grant, support roles and independence - Materials to obtain first: Funding, support-role and agreement disclosures - Further research: Proposed follow-up trial disclosing support/research roles; no new investigation, calculation or trial was performed in this production. - Conditions for verification: Corresponding original materials and analysis scope for distinction between funder/grant, support roles and independence must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between funder/grant, support roles and independence to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items. - Related sources: S01 ### N25 · Non-reporting of support in the pivotal paper Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript states that commercial sponsorship, donated scales, outsourced analysis, medical writing and publication-fee support were not reported in the pivotal paper. Non-reporting is not judged as actual absence of support. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Actual presence/scope of each support category, agreements, analysis/writing roles and original disclosures remain unread. Existing content review remains incomplete. - Reason for missing information: Actual presence/scope of each support category, agreements, analysis/writing roles and original disclosures remain unread. - Required materials and conditions: Category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support - Materials to obtain first: Commercial/in-kind, analysis and writing/publication support disclosures - Further research: A proposed study disclosing support categories distinctly; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N26 · Later author relationships and disclosure timing Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original record places later-paper disclosures of Gary Bennett’s WW advisory role and equity in Coeus Health after the pivotal trial. Funding/COI during that trial are not retrospectively established. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific later bibliography, disclosure timing, relationships/agreements during the original trial and complete COI remain unlinked/unread. Existing content review remains incomplete. - Reason for missing information: Specific later bibliography, disclosure timing, relationships/agreements during the original trial and complete COI remain unlinked/unread. - Required materials and conditions: Distinction between later WW/Coeus disclosures and original-trial timing/roles - Materials to obtain first: Later disclosures, dates and relationship materials with original-trial statements - Further research: A proposed study distinguishing relationship/support attribution by period; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between later WW/Coeus disclosures and original-trial timing/roles must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between later WW/Coeus disclosures and original-trial timing/roles to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N27 · References to null results from other programs Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: References to null trials of app-only or low-intensity technology support limit generalization because composition/intensity differ. Those reports are not newly created or combined as direct refutations or independent replications of Track’s responder result. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific bibliography, populations, proportions/endpoints, denominators and results for other programs remain unlinked. Existing content review remains incomplete. - Reason for missing information: Specific bibliography, populations, proportions/endpoints, denominators and results for other programs remain unlinked. - Required materials and conditions: Directness of Track’s bundle versus app-only/low-intensity programs - Materials to obtain first: Other-program originals and composition/endpoint relationships - Further research: A proposed direct follow-up comparison matching composition and intensity; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for directness of Track’s bundle versus app-only/low-intensity programs must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing directness of Track’s bundle versus app-only/low-intensity programs to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N28 · Same report, sibling sheets and independence Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The 5% and mean sheets share the same Bennett2018 Track trial of 351 participants. Groups, time points, thresholds, bibliography/registration and sibling sheets are not added as new independent trials or participants. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent reproduction under the same bundle/responder conditions and unique clinical totals are not established. Existing content review remains incomplete. - Reason for missing information: Independent reproduction under the same bundle/responder conditions and unique clinical totals are not established. - Required materials and conditions: Mean/responder, report/registration and group/time-point relationships - Materials to obtain first: Report/cohort relationships and originals of separate independent trials - Further research: A proposed independent follow-up comparison specifying the same secondary threshold; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for mean/responder, report/registration and group/time-point relationships must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing mean/responder, report/registration and group/time-point relationships to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N29 · Persistence and applicability to other compositions/populations Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The 12-month bundled trial’s responder result is not extended to all apps/products, other populations, maintenance after stopping the intervention or disease treatment. No new recommendations or weight-loss instructions are created. - Why unverified: 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 compositions/populations and direct single-component comparisons remain unverified. Existing content review remains incomplete. - Reason for missing information: Long-term/discontinuation follow-up, other compositions/populations and direct single-component comparisons remain unverified. - Required materials and conditions: Distinction between Track responder results and long-term/stand-alone-app/other-population effects - Materials to obtain first: Long-term follow-up and direct comparisons by composition/population - Further research: A proposed study distinguishing threshold attainment from persistence/applicability; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for distinction between Track responder results and long-term/stand-alone-app/other-population effects must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing distinction between Track responder results and long-term/stand-alone-app/other-population effects to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design - Related sources: S01 ### N30 · Unknown safety and collection gaps Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original record states that parent safety is unknown and adverse events from a prespecified safety endpoint were not systematically presented in the pivotal paper. Attaining 5% loss is not converted into absence of harm or treatment safety. - Why unverified: 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 types/frequencies/denominators, discontinuation and vulnerable-population/long-term harms remain unverified. Existing content review remains incomplete. - Reason for missing information: Adverse-event collection/adjudication, group-specific types/frequencies/denominators, discontinuation and vulnerable-population/long-term harms remain unverified. - Required materials and conditions: Prespecification, collection/denominators and follow-up for adverse events - Materials to obtain first: Safety plans, adverse events and discontinuation/long-term follow-up - Further research: A proposed follow-up study specifying harm collection and follow-up; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for prespecification, collection/denominators and follow-up for adverse events must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing prespecification, collection/denominators and follow-up for adverse events to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N31 · Parent/subclaim, Korean/English, corrections and history Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 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 inherited as current review or a subclaim score. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Absent subclaim score/status/axes are not filled with parent values, and no new certification is created. Existing content review remains incomplete. - Reason for missing information: Absent subclaim score/status/axes are not filled with parent values, and no new certification is created. - Required materials and conditions: Separate preservation of original values/axes, reference dates and verification narratives - Materials to obtain first: Original corrections, versions and user correction comments - Further research: Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production. - Conditions for verification: Corresponding original materials and analysis scope for separate preservation of original values/axes, reference dates and verification narratives must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing separate preservation of original values/axes, reference dates and verification narratives to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ### N32 · Summary reading, external links and updates Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 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. - Why unverified: Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. External originals, exact responder denominators/models and actual accessibility remain unverified. Existing content review remains incomplete. - Reason for missing information: External originals, exact responder denominators/models and actual accessibility remain unverified. - Required materials and conditions: Actually read scope and access status of external materials - Materials to obtain first: Originals, registration, protocol, SAP, support/COI materials or user comments - Further research: A proposed study updating acquisition, timing and scope of materials separately; no new investigation, calculation or trial was performed. - Conditions for verification: Corresponding original materials and analysis scope for actually read scope and access status of external materials must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete. - Why this condition is needed: An applied item distinguishing actually read scope and access status of external materials to connect the selected question’s needed materials with current materials. - Application exceptions: 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: 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 - Related sources: S01 ## Evidence and sources ### S01 Bennett GG et al. 2018 Track [PubMed](https://pubmed.ncbi.nlm.nih.gov/30361140/) Materials actually read: Summary read; external material unread Findings recorded in the summary: −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. Record level: Outcome wording in the stored summary Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution ## What the statuses mean - 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. ## Change history 2026-10-14 · Public page/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.