NCT07463144

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

Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: BetterMe Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obesity is a growing public health concern worldwide, contributing to chronic conditions such as type 2 diabetes, cardiovascular disease, and mental health challenges. Digital wellness interventions, including mobile apps and wearable devices, have the potential to support behavior change, physical activity, and weight management. This study will examine whether adding a wearable fitness tracker to a mobile wellness application enhances health outcomes compared with app-only use or standard health information. The trial is decentralized, conducted remotely, and does not require in-person visits. Participants will complete baseline assessments, be randomized into one of three study arms, and follow a structured program for 12 weeks. Self-reported surveys, weight measurements (with optional video verification), app usage data, and wearable-collected data (for the tracker group) will be used to evaluate outcomes.

Conditions

• Obesity & Overweight

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States