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

BetterMe Limited

Status: Not yet enrolling

Conditions: Obesity & Overweight

Treatments: Behavioral: App Only; Behavioral: Control Group; Behavioral: App + Fitness Tracker

Study type: Interventional

Funder types: Industry

Identifiers

NCT07463144

12192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

App + Fitness Tracker

Experimental group

Description:

Participants using both a mobile wellness app and a wearable fitness tracker.

Treatment:

Behavioral: App + Fitness Tracker

App Only

Experimental group

Description:

participants using only the mobile wellness app.

Treatment:

Behavioral: App Only

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Group