Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes
Starting soon · Not applicable
Conditions studied: Obesity & Overweight
In brief
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.
Key facts
- Study ID
- NCT07463144
- Run by
- BetterMe Limited
- People needed
- 300
- Starts
- 2026-03-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- A baseline BMI < 25
- Pregnant or planning to become pregnant
- Breast-feeding or less than 6 months postpartum
- 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
- Recent significant weight loss (e.g., >5-10% in the last 6 months)
- Extreme life circumstances (e.g. family illness, recently lost job, going through a divorce)
- 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
- Current, previous (in the last 6 months), or planned use of weight loss medications (e.g., Ozempic, Wegovy, etc.) (in the next 6 months)
Where it is running
- Sterling Institutional Review Board - Remote/Virtual Participation Only — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.