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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
- Procedures mentioned: Wearing a device, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 12-week study tests whether the BetterMe wellness app, with or without a fitness tracker, helps with weight, exercise, and mental well-being. It is for adults with a BMI of 25 or higher who rarely or never exercise. People are placed by chance into one of three groups: app plus tracker, app only, or standard health information.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Have a BMI of 25 or higher. BMI is a measure based on height and weight.
- Willing to use the BetterMe app and fitness tracker for the whole study.
- Own a smartphone.
- Report exercising only several times a month or never.
- Say you believe you can succeed, or are unsure but willing to try.
- Willing to use a scale to weigh yourself and send a video recording.
Who can't join
- Have a BMI below 25.
- Are pregnant, plan to become pregnant, are breast-feeding, or gave birth less than 6 months ago.
- Have a diagnosed sleep disorder, such as insomnia (trouble sleeping) or sleep apnea (breathing pauses during sleep).
- Have a diagnosed thyroid, liver, kidney, heart or blood vessel disease; cancer-related disease; moderate to severe depression or anxiety; bipolar disorder; or schizophrenia.
- Recently lost a large amount of weight, such as more than 5–10% in the last 6 months.
- Face major life stress, such as family illness, recent job loss, or divorce; or cannot exercise regularly during the study for any reason.
- Used the same wellness app or fitness tracker in the last year, or are now in another weight loss program or working with a dietitian.
- Use weight loss medicines, used them in the last 6 months, or plan to use them in the next 6 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
GA
- Sterling Institutional Review Board - Remote/Virtual Participation Only · Atlanta, GA 30328More trials in Atlanta