Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and… (NCT07463144) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes
United States300 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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, …