Testing a wellness app, with or without a fitness tracker, for weight loss
Tests a wellness app, with or without a wearable, in adults with overweight.
Key facts
- Who runs it
- BetterMe Limited
- Where
- Atlanta, United StatesSee the site
- Trial code
- Registry title
- Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes
- Status
- Not yet recruiting
- People taking part
- 300 people, planned
- Started
- Mar 2026
- Planned end
- Aug 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- App + Fitness Tracker
- App Only
- Control Group
- Record updated
- 11 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for inactive adults with a BMI of 25 or more who are willing to use the BetterMe app and a fitness tracker for the whole study.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Baseline BMI of 25 or more; currently inactive.
- Earlier treatment
- Cannot have used the same app or tracker in the last year, taken weight loss medicines in the last 6 months or be in another weight loss program.
Main reasons for not taking part
- BMI below 25
- Pregnant, planning pregnancy, breast-feeding or less than 6 months postpartum
- Sleep disorder, or thyroid, liver, kidney, heart, serious mental illness or cancer-related disease
- Recent significant weight loss (for example >5-10% in the last 6 months)
- Current or planned use of weight loss medications (for example Ozempic, Wegovy)
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Age: 18+ years
- A baseline BMI ≥ 25
- Willing to use the BetterMe mobile wellness app and fitness tracker for the entirety of the study
- Ownership of a smartphone
- Currently inactive, as defined by acknowledging "several times a month" or "never" to the exercise frequency question in the screener
- Acknowledging "I believe I can do it" or "I'm uncertain, but willing to try" to the confidence to succeed question in the screener
- Willingness to use scales for body weighing and submit video recording
Who cannot take part
- Current, previous (in the last 6 months), or planned use of weight loss medications (e.g., Ozempic, Wegovy, etc.) (in the next 6 months)
- Currently diagnosed with insomnia, sleep apnea, or other clinical sleep disorder
- Diagnosed thyroid, liver, kidney, cardiovascular, moderate-severe depression or anxiety, bipolar disorder, schizophrenia, or cancer-related disease
- Extreme life circumstances (e.g. family illness, recently lost job, going through a divorce)
- A baseline BMI < 25
- Pregnant or planning to become pregnant
- Breast-feeding or less than 6 months postpartum
- Recent significant weight loss (e.g., >5-10% in the last 6 months)
- Cannot participate in a regular exercise routine for any reason during the course of the study (i.e. contraindications to exercise)
- Used the same mobile wellness app and/or fitness tracker in the last year
- Currently enrolled in an additional weight loss program (e.g. Noom, WW, health coaching) and/or working with a dietician
Where in United States
- Sterling Institutional Review Board - Remote/Virtual Participation OnlyAtlanta, United StatesNot yet recruiting
About the trial
What the trial wants to find out
This randomized controlled trial aims to evaluate the effectiveness of a mobile wellness application, both alone and in combination with a wearable fitness tracker, for supporting weight management, physical activity, and mental well-being. Adults with a body mass index (BMI) ≥25 will be randomized to one of three groups: (1) mobile wellness application + wearable tracker, (2) mobile wellness application only, or (3) control receiving standard health information. Participants will use the interventions over a 12-week period, and outcomes including weight change, activity levels, and self-reported mental health will be assessed.
The 3 groups in the trial
- App + Fitness TrackerTreatment being tested
Participants using both a mobile wellness app and a wearable fitness tracker.
- App OnlyTreatment being tested
participants using only the mobile wellness app.
- Control GroupExisting treatment, for comparison
Participants who follow their normal health/ exercise routines, and will receive access to the BetterMe wellness blog and weekly email content to provide general wellness information.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform
- Plain-language title
- Testing a wellness app, with or without a fitness tracker, for weight lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 11 March 2026