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

NCT07430618 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11524

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

  • Overweight (BMI > 25)
  • Obesity (Body Mass Index >30 kg/m2)
  • Obesity & Overweight

Interventions

DEVICE

Breath acetone biofeedback device with mHealth program

A breath acetone biofeedback device used alongside the Key to Health mobile app as part of a comprehensive weight-loss program. Users obtain breath acetone readings via the device and record body weight via manual entry and/or connected scale. The app provides program resources to support behavior change, including a food database/food logging tools, nutrition and exercise education (lessons, articles, and other content), alerts/notifications, and engagement features (e.g., streaks and progress tracking). This study retrospectively analyzes de-identified data generated during routine program use; no study-specific procedures are administered.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jonathan Little · UBC Okanagan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-18
Primary Completion
2025-04-25
Completion
2025-04-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430618 on ClinicalTrials.gov