Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes (NCT07463144)
Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform
๐ฉบ Plain-English Summary (8th-Grade Level)
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) โฅ25 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 join: Review the eligibility criteria below.
Location: Sterling Institutional Review Board - Remote/Virtual Participation Only โ Atlanta, Georgia
Age range: 18 Years
๐งช Interventions in This Study
- App + Fitness Tracker (BEHAVIORAL)
- App Only (BEHAVIORAL)
- Control Group (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Sterling Institutional Review Board - Remote/Virtual Participation Only โ Atlanta, Georgia
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.