Not Yet RecruitingNot Applicable

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

United States300 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight Change

Timeframe: 3 months

Trial details

NCT IDNCT07463144

SponsorBetterMe Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Obesity & Overweight trials