Obesity & Overweight
Conditions
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.
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.
Interventions
BEHAVIORALApp + 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.
BEHAVIORALApp 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.
BEHAVIORALControl 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.
Sponsors
BetterMe Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 3 months | Change in % body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 3 months | 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. |
| Mental Health: Total Anxiety Score | 3 months | 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. |
| Mental Health: Depression Total Score | 3 months | 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. |
| Health-Related Quality of Life | 3 months | 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). |
| App usage metrics: Time | 3 months | Metric: Time spent in app (minutes) |
| App usage metrics: Exercise Count | 3 months | Metric: Exercises started/completed (count) |
| App usage metrics: Frequency | 3 months | Metric: Frequency of logging (number of logins). |
Countries
United States
Outcome results
None listed