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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Behavioral: App + Fitness Tracker; Behavioral: App Only; Behavioral: Control Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Sterling Institutional Review Board - Remote/Virtual Participation Only

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App + Fitness Tracker; Participants using both a mobile wellness app and a wearable fitness tracker.	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.
Experimental: App Only; participants using only the mobile wellness app.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Change in % body weight	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Physical activity levels (self-reported via IPAQ (International Physical Activity Questionnaire) and wearable devices. Scale: IPAQ score ranges from 0 to 1000+ MET-minutes/week (where higher scores indicate higher activity levels). Wearable Tracking: Data from wearable devices will be summarized in minutes of activity per week.	3 months
Mental Health: Total Anxiety Score	Measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report questionnaire used to assess the severity of generalized anxiety disorder. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score is calculated by summing the scores of all 7 items, resulting in a single value ranging from 0 to 21. Higher scores indicate greater anxiety severity.	3 months
Mental Health: Depression Total Score	Measured using the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 is an 8-item self-report instrument used to measure the severity of depressive symptoms. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is calculated by summing the scores of all 8 items, resulting in a single value ranging from 0 to 24. Higher scores indicate greater severity of depressive symptoms.	3 months
Health-Related Quality of Life	Short Form 12 (SF-12), Health-Related Quality of Life Scale Scale: Scores range from 0 to 100 (where higher scores indicate better health-related quality of life).	3 months
App usage metrics: Time	Metric: Time spent in app (minutes)	3 months
App usage metrics: Exercise Count	Metric: Exercises started/completed (count)	3 months
App usage metrics: Frequency	Metric: Frequency of logging (number of logins).	3 months

Collaborators and Investigators

• Sponsor: BetterMe Limited

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Equipment and Supplies; Macromolecular Substances; Multiprotein Complexes; Electrical Equipment and Supplies; Diagnostic Equipment; Wearable Electronic Devices; Control Groups; Amyloid; Fitness Trackers
• Other Study ID Numbers: 12192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the consent obtained from participants does not include permission for sharing de-identified data beyond the study team, and maintaining confidentiality is a priority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No