Real-World Durability of Weight Loss With a Breath Biofeedback mHealth Program: Two-Year Outcomes in Adults With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,524
- 试验地点
- 1
- 主要终点
- Percent Total Body Weight Loss (TBWL%) at Week 104.
研究概览
简要总结
The goal of this retrospective observational study is to evaluate the real-world durability of weight loss among adults with overweight or obesity who used the Key to Health breath-biofeedback mHealth program. The main questions it aims to answer are:
- What is the mean percent total body weight loss (TBWL%) at 104 weeks after program start?
- What are the TBWL% estimates at 12, 24, and 52 weeks, and what proportion of users achieve clinically meaningful weight loss (≥5% and ≥10%) at 52 and 104 weeks (observed case)?
Users initiated the program between Nov 2018 and Apr 2023; follow-up data (weights/engagement) were collected through Apr 2025 to allow up to 104 weeks of observation.
There is no randomized comparison group. Participants will not be asked to do anything beyond normal app use; the study will analyze existing, de-identified weight and engagement data collected during routine program use.
详细描述
This is a retrospective, observational real-world evidence study using de-identified backend data from commercially active users of the Key to Health digital weight loss program between November 2018 and April 2025. Eligible users are adults (≥18 years) with a valid onboarding baseline weight and at least one post-baseline weight entry; users must meet the pre-specified baseline BMI threshold for overweight/obesity. Baseline weight is defined as the self-reported onboarding weight. Follow-up weights are defined as user-entered or connected-scale weights recorded after onboarding.
Weight outcomes are assigned to prespecified follow-up windows at Weeks 12, 24, 52, and 104 using a deterministic rule: the weight entry closest to each target day within its window (earlier chosen if equidistant). The primary endpoint is TBWL% at Week 104, defined as (post-baseline weight - baseline weight) / baseline weight × 100. Secondary outcomes include TBWL% at Weeks 12, 24, and 52; absolute weight change; and observed-case responder summaries at Weeks 52 and 104.
The primary analysis will estimate longitudinal TBWL% across visits using a Mixed Model for Repeated Measures (MMRM) with visit as a categorical factor and adjustment for baseline covariates (e.g., baseline weight, age, sex, cohort year). Missing data will be handled under a Missing At Random (MAR) framework inherent to the MMRM approach (no single-value imputation in the primary analysis). Pre-specified sensitivity analyses may be conducted as feasible (e.g., conservative assumptions for missing Week-104 outcomes and weighted approaches for differential observation), with any deviations from the prespecified plan documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years at program start/onboarding
- •Program start date between November 2018 and April 2023
- •Valid baseline (onboarding) self-reported weight recorded
- •Baseline BMI >25 kg/m²
- •At least one valid post-baseline weight entry recorded after onboarding (manual and/or connected scale)
排除标准
- •Missing or invalid baseline weight
- •Biologically implausible baseline weight (per prespecified data-quality checks)
- •No post-baseline weight data recorded after the baseline date/onboarding timestamp
研究组 & 干预措施
Key to Health Program Users (Commercial Cohort)
Adults with overweight or obesity who enrolled in and used the Key to Health breath-biofeedback mHealth weight-loss program during the data collection window and had a valid onboarding baseline weight plus at least one post-baseline weight entry recorded via the app and/or a connected scale.
干预措施: Breath acetone biofeedback device with mHealth program (Device)
结局指标
主要结局
Percent Total Body Weight Loss (TBWL%) at Week 104.
时间窗: Week 104 (target Day 728; visit window Days 668-788 after program start).
TBWL% at Week 104 is defined as: (post-baseline weight - baseline weight) / baseline weight × 100, where baseline weight is the self-reported onboarding weight. The Week-104 weight is the post-baseline weight entry closest to Day 728 within the prespecified visit window (Days 668-788; earlier selected if equidistant).
次要结局
- Percent Total Body Weight Loss (TBWL%) at Week 52(Week 52 (target Day 364; visit window Days 334-394))
- Percent Total Body Weight Loss (TBWL%) at Week 24(Week 24 (target Day 168; visit window Days 138-198))
- Percent Total Body Weight Loss (TBWL%) at Week 12(Week 12 (target Day 84; visit window Days 69-99))
- Proportion Achieving ≥5% Weight Loss at Week 52 (Observed Case)(Week 52 (target Day 364; visit window Days 334-394))
- Proportion Achieving ≥10% Weight Loss at Week 52 (Observed Case)(Week 52 (target Day 364; visit window Days 334-394))
- Proportion Achieving ≥5% Weight Loss at Week 104 (Observed Case)(Week 104 (target Day 728; visit window Days 668-788))
- Proportion Achieving ≥10% Weight Loss at Week 104 (Observed Case)(Week 104 (target Day 728; visit window Days 668-788))
- Absolute Weight Change (lb) at Week 104(Week 104 (target Day 728; visit window Days 668-788))
- Absolute Weight Change (lb) at Week 52(Week 52 (target Day 364; visit window Days 334-394))
- Absolute Weight Change (lb) at Week 24(Week 24 (target Day 168; visit window Days 138-198))
- Absolute Weight Change (lb) at Week 12(Week 12 (target Day 84; visit window Days 69-99))
研究者
Jonathan Little
Professor
University of British Columbia