AzTrials
AzTrials

Obesity & OverweightNCT07463144

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

A study testing App + Fitness Tracker and App Only in people with Obesity & Overweight, run by BetterMe Limited at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity & Overweight
What is being tested?
App + Fitness Tracker and App Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Mar 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Sterling Institutional Review Board - Remote/Virtual Participation Only

    Atlanta, Georgia, 30328

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
App + Fitness Tracker, App Only, Control Group
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App + Fitness TrackerBehavioural

    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 OnlyBehavioural

    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.

  • Control GroupBehavioural

    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.

Study groups in NCT07463144
Study groupRoleWhat they receive
App + Fitness TrackerExperimentalParticipants using both a mobile wellness app and a wearable fitness tracker.
Receives: Behavioral: App + Fitness Tracker
App OnlyExperimentalparticipants using only the mobile wellness app.
Receives: Behavioral: App Only
Control GroupActive comparatorParticipants 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.
Receives: Behavioral: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change

    Change in % body weight

    Measured: 3 months

Secondary outcomes (7)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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).

    Measured: 3 months

  5. App usage metrics: Time

    Metric: Time spent in app (minutes)

    Measured: 3 months

  6. App usage metrics: Exercise Count

    Metric: Exercises started/completed (count)

    Measured: 3 months

  7. App usage metrics: Frequency

    Metric: Frequency of logging (number of logins).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07463144
Sponsor's protocol ID
12192
Status last verified
Mar 2026
First submitted
12 Jan 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing App + Fitness Tracker and App Only in people with Obesity & Overweight, run by BetterMe Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07463144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in