NCT07463144Not yet recruiting
Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes
Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- BetterMe Limited
- Diseases
- Obesity
- NCT number
- NCT07463144
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Mar 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current, previous (in the last 6 months), or planned use of weight loss medications (e.g., Ozempic, Wegovy, etc.) (in the next 6 months)
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sterling Institutional Review Board - Remote/Virtual Participation Only Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.