Clinical Trial

Real-World Two-Year Weight Loss Outcomes With Breath Biofeedback

Completed
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Summary
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: 1. What is the mean percent total body weight loss (TBWL%) at 104 weeks after program start? 2. 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.
Trial Details
NCT Number NCT07430618
Lead Sponsor University of British Columbia
Conditions Overweight (BMI > 25), Obesity (Body Mass Index >30 kg/m2), Obesity & Overweight
Enrollment 11,524 participants
Start Date 2018-11-18
Primary Completion 2025-04-25 (estimated)
Study Completion 2025-04-25 (estimated)
Updated on ClinicalTrials.gov 2026-02-24