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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
BetterMe Limited
Study ID
NCT07463144
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • App + Fitness Tracker — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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 Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: App + Fitness Tracker
    Participants using both a mobile wellness app and a wearable fitness tracker.
  • Experimental: App Only
    participants using only the mobile wellness app.
  • Active Comparator: Control Group
    Participants who follow their normal health/ exercise routines, and will receive access to the BetterMe wellness blog and weekly email content to provide general wellness information.

Primary Outcome Measure

Weight Change [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sterling Institutional Review Board - Remote/Virtual Participation OnlyAtlantaGeorgia30328-

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Sterling Institutional Review Board - Remote/Virtual Participation Only· Atlanta, GA

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