Overweight (BMI > 25)NCT07430618
Real-World Two-Year Weight Loss Outcomes With Breath Biofeedback
An observational study of Overweight (BMI > 25) and Obesity (Body Mass Index >30 kg/m2), run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight (BMI > 25), Obesity (Body Mass Index >30 kg/m2), Obesity & Overweight
- What is being tested?
- Breath acetone biofeedback device with mHealth program
- Type of treatment
- Medical device
- How many people
- 11,524 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2018to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Commercial users of the Key to Health digital weight loss program (mobile app) who enrolled and used the program during the data collection window. Users are members of the general community who accessed the program through routine commercial availability (direct-to-consumer), and who recorded weight measurements during typical use of the app and/or a connected scale. De-identified backend program data were used for this retrospective analysis.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Durability of Weight Loss With a Breath Biofeedback mHealth Program: Two-Year Outcomes in Adults With Overweight or Obesity
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)?
Read more
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.
Read the detailed description
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.
- Being tested
- Breath acetone biofeedback device with mHealth program
- Keywords
- Overweight, Obesity, Breath sensor, Biofeedback, Digital Health, Weight loss, Weight management
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath acetone biofeedback device with mHealth programDevice
Also called Key to Health Breath Sensor, Key to Health Program, Keyto Breath Acetone Device, Keyto Breath Acetone Sensor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Breath acetone biofeedback device with mHealth program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Total Body Weight Loss (TBWL%) at Week 104.
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).
Measured: Week 104 (target Day 728; visit window Days 668-788 after program start).
Secondary outcomes (11)
Percent Total Body Weight Loss (TBWL%) at Week 52
TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100, where baseline weight is the self-reported onboarding weight. The Week-52 weight is the post-baseline weight entry closest to Day 364 within the visit window (Days 334-394; earlier selected if equidistant).
Measured: Week 52 (target Day 364; visit window Days 334-394)
Percent Total Body Weight Loss (TBWL%) at Week 24
TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100. The Week-24 weight is the post-baseline weight entry closest to Day 168 within the visit window (Days 138-198; earlier selected if equidistant).
Measured: Week 24 (target Day 168; visit window Days 138-198)
Percent Total Body Weight Loss (TBWL%) at Week 12
TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100. The Week-12 weight is the post-baseline weight entry closest to Day 84 within the visit window (Days 69-99; earlier selected if equidistant).
Measured: Week 12 (target Day 84; visit window Days 69-99)
Proportion Achieving ≥5% Weight Loss at Week 52 (Observed Case)
Proportion of users with TBWL% ≤ -5% at Week 52 among users with an observed in-window Week-52 weight (Days 334-394). TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100.
Measured: Week 52 (target Day 364; visit window Days 334-394)
Proportion Achieving ≥10% Weight Loss at Week 52 (Observed Case)
Proportion of users with TBWL% ≤ -10% at Week 52 among users with an observed in-window Week-52 weight (Days 334-394). TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100.
Measured: Week 52 (target Day 364; visit window Days 334-394)
Proportion Achieving ≥5% Weight Loss at Week 104 (Observed Case)
Proportion of users with TBWL% ≤ -5% at Week 104 among users with an observed in-window Week-104 weight (Days 668-788). TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100.
Measured: Week 104 (target Day 728; visit window Days 668-788)
Proportion Achieving ≥10% Weight Loss at Week 104 (Observed Case)
Proportion of users with TBWL% ≤ -10% at Week 104 among users with an observed in-window Week-104 weight (Days 668-788). TBWL% defined as (post-baseline weight - baseline weight) / baseline weight × 100.
Measured: Week 104 (target Day 728; visit window Days 668-788)
Absolute Weight Change (lb) at Week 104
Absolute weight change in pounds at Week 104, defined as post-baseline weight at Week 104 minus baseline self-reported onboarding weight. Week-104 weight selected as the entry closest to Day 728 within Days 668-788.
Measured: Week 104 (target Day 728; visit window Days 668-788)
Absolute Weight Change (lb) at Week 52
Absolute weight change in pounds at Week 52, defined as post-baseline weight at Week 52 minus baseline self-reported onboarding weight. Week-52 weight selected as the entry closest to Day 364 within Days 334-394.
Measured: Week 52 (target Day 364; visit window Days 334-394)
Absolute Weight Change (lb) at Week 24
Absolute weight change in pounds at Week 24, defined as post-baseline weight at Week 24 minus baseline self-reported onboarding weight. Week-24 weight selected as the entry closest to Day 168 within Days 138-198.
Measured: Week 24 (target Day 168; visit window Days 138-198)
Absolute Weight Change (lb) at Week 12
Absolute weight change in pounds at Week 12, defined as post-baseline weight at Week 12 minus baseline self-reported onboarding weight. Week-12 weight selected as the entry closest to Day 84 within Days 69-99.
Measured: Week 12 (target Day 84; visit window Days 69-99)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Nov 2018
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan Little, Principal investigator, UBC Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430618
- Sponsor's protocol ID
- 20260202
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset is derived from a commercial digital health program and contains sensitive user-level information. Only de-identified and aggregated results will be reported, and any data sharing would be subject to applicable privacy, consent, and contractual restrictions.
Publications
Falkenhain K, Lowe DA, Locke SR, Singer J, Weiss EJ, Little JP. Long-Term Weight Loss in Adults With Overweight or Obesity Using a Breath Biofeedback mHealth App: A One-Year Follow-Up of a Randomized Trial. Obes Sci Pract. 2025 Dec 5;11(6):e70106. doi: 10.1002/osp4.70106. eCollection 2025 Dec.
PubMed 41356752Falkenhain K, Locke SR, Lowe DA, Lee T, Singer J, Weiss EJ, Little JP. Use of an mHealth Ketogenic Diet App Intervention and User Behaviors Associated With Weight Loss in Adults With Overweight or Obesity: Secondary Analysis of a Randomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Mar 14;10(3):e33940. doi: 10.2196/33940.
PubMed 35285809Falkenhain K, Locke SR, Lowe DA, Reitsma NJ, Lee T, Singer J, Weiss EJ, Little JP. Keyto app and device versus WW app on weight loss and metabolic risk in adults with overweight or obesity: A randomized trial. Obesity (Silver Spring). 2021 Oct;29(10):1606-1614. doi: 10.1002/oby.23242. Epub 2021 Sep 14.
PubMed 34124856
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Durability of Weight Loss With a Breath Biofeedback mHealth Program: Two-Year Outcomes in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07430618
- Acronym / sponsor ID
- 20260202
- Keywords
- Overweight, Obesity, Breath sensor, Biofeedback, Digital Health, Weight loss, Weight management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,524 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Key to Health Program Users (Commercial Cohort) | – | Device: Breath acetone biofeedback device with mHealth programAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Commercial users of the Key to Health digital weight loss program (mobile app) who enrolled and used the program during the data collection window. Users are members of the general community who accessed the program through routine commercial availability (direct-to-consumer), and who recorded weight measurements during typical use of the app and/or a connected scale. De-identified backend program data were used for this retrospective analysis.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath acetone biofeedback device with mHealth programAlso: Key to Health Breath Sensor, Key to Health Program, Keyto Breath Acetone Device, Keyto Breath Acetone SensorA 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. | Device | Key to Health Program Users (Commercial Cohort) |
Primary outcome
Percent Total Body Weight Loss (TBWL%) at Week 104.
Time frame: 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).
11 secondary outcomes
Percent Total Body Weight Loss (TBWL%) at Week 52
Time frame: Week 52 (target Day 364; visit window Days 334-394)
Percent Total Body Weight Loss (TBWL%) at Week 24
Time frame: Week 24 (target Day 168; visit window Days 138-198)
Percent Total Body Weight Loss (TBWL%) at Week 12
Time frame: Week 12 (target Day 84; visit window Days 69-99)
Proportion Achieving ≥5% Weight Loss at Week 52 (Observed Case)
Time frame: Week 52 (target Day 364; visit window Days 334-394)
Proportion Achieving ≥10% Weight Loss at Week 52 (Observed Case)
Time frame: Week 52 (target Day 364; visit window Days 334-394)
Proportion Achieving ≥5% Weight Loss at Week 104 (Observed Case)
Time frame: Week 104 (target Day 728; visit window Days 668-788)
Proportion Achieving ≥10% Weight Loss at Week 104 (Observed Case)
Time frame: Week 104 (target Day 728; visit window Days 668-788)
Absolute Weight Change (lb) at Week 104
Time frame: Week 104 (target Day 728; visit window Days 668-788)
Absolute Weight Change (lb) at Week 52
Time frame: Week 52 (target Day 364; visit window Days 334-394)
Absolute Weight Change (lb) at Week 24
Time frame: Week 24 (target Day 168; visit window Days 138-198)
Absolute Weight Change (lb) at Week 12
Time frame: Week 12 (target Day 84; visit window Days 69-99)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 41356752Falkenhain K, Lowe DA, Locke SR, Singer J, Weiss EJ, Little JP. Long-Term Weight Loss in Adults With Overweight or Obesity Using a Breath Biofeedback mHealth App: A One-Year Follow-Up of a Randomized Trial. Obes Sci Pract. 2025 Dec 5;11(6):e70106. doi: 10.1002/osp4.70106. eCollection 2025 Dec.
- Background: PubMed 35285809Falkenhain K, Locke SR, Lowe DA, Lee T, Singer J, Weiss EJ, Little JP. Use of an mHealth Ketogenic Diet App Intervention and User Behaviors Associated With Weight Loss in Adults With Overweight or Obesity: Secondary Analysis of a Randomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Mar 14;10(3):e33940. doi: 10.2196/33940.
- Background: PubMed 34124856Falkenhain K, Locke SR, Lowe DA, Reitsma NJ, Lee T, Singer J, Weiss EJ, Little JP. Keyto app and device versus WW app on weight loss and metabolic risk in adults with overweight or obesity: A randomized trial. Obesity (Silver Spring). 2021 Oct;29(10):1606-1614. doi: 10.1002/oby.23242. Epub 2021 Sep 14.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset is derived from a commercial digital health program and contains sensitive user-level information. Only de-identified and aggregated results will be reported, and any data sharing would be subject to applicable privacy, consent, and contractual restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Little principal investigator
UBC Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight (BMI > 25) and Obesity (Body Mass Index >30 kg/m2), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Total Body Weight Loss (TBWL%) at Week 104. (time frame: Week 104 (target Day 728; visit window Days 668-788 after program start).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.