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

NCT07463144 | Not Yet Recruiting

• 1 other identifier: 12192
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Change in % body weight

  3 months

Secondary Outcomes (7)

• Physical Activity

  3 months

• Mental Health: Total Anxiety Score

  3 months

• Mental Health: Depression Total Score

  3 months

• Health-Related Quality of Life

  3 months

• App usage metrics: Time

  3 months

Study Arms (3)

App + Fitness Tracker

EXPERIMENTAL

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

Behavioral: App + Fitness Tracker

App Only

EXPERIMENTAL

participants using only the mobile wellness app.

Behavioral: App Only

Control Group

ACTIVE COMPARATOR

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

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 + Fitness Tracker

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.

App Only

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• BetterMe Limited: lead

Study Sites (1)

Sterling Institutional Review Board - Remote/Virtual Participation Only

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Amyloid; Fitness Trackers; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)