๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-06

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

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: BetterMe Limited

๐Ÿฉบ 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) โ‰ฅ25 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

๐Ÿงช Interventions in This Study

  • App + Fitness Tracker (BEHAVIORAL)
  • App Only (BEHAVIORAL)
  • Control Group (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Sterling Institutional Review Board - Remote/Virtual Participation Only โ€” Atlanta, Georgia

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—