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Clinical Trials in the USA / NCT07463144
Starting soon Not applicable

Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes

NCT07463144 · tracked via the Priya Life Science USA tracker
Sponsor
BetterMe Limited
Phase
Not applicable
Started
2026-03
Last updated
2026-03-11

Condition(s) studied

Obesity & Overweight

Investigational drug(s) / intervention(s)

App + Fitness TrackerApp OnlyControl Group

App + Fitness Tracker: Participants will use a commercially available mobile wellness app alongside a wearable fitness tracker. The app provides personalized exercise programs, habit tracking, progress monitoring, and motivational support. The wearable collects daily steps, heart rate, heart rate variability, and sleep metrics to enhance personalized feedback. Participants are encouraged to engage with both tools daily over a 12-week period to support weight management, physical activity, and overall well-being.

App Only: Participants will use the same mobile wellness app without the wearable fitness tracker. The app delivers personalized exercise programs, habit tracking, progress monitoring, and motivational support. Participants are encouraged to use the app daily over 12 weeks to support weight management, physical activity, and overall well-being.

Control Group: Participants will continue their usual health and exercise routines without access to the app or wearable tracker. They will receive standard wellness information via email or blog posts over the 12-week study period. This group serves as a comparison to evaluate the effects of the interventions on weight management, physical activity, and well-being.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, Wegovy, etc.) (in the next 6 months)

Primary outcome measure(s)

  • Weight Change — 3 months
    Change in % body weight

Trial sites (1)

FacilityCityRegionStatus
Sterling Institutional Review Board - Remote/Virtual Participation Only Atlanta Georgia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07463144 on ClinicalTrials.gov ↗ ← All trials in the USA