Mobile App + Fitness Tracker for Obesity

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile wellness app, alone or with a fitness tracker, can help people manage weight, stay active, and improve mental well-being. Participants will divide into three groups: one using both the app and tracker, one using just the app, and a control group receiving standard health tips. Individuals with a BMI of 25 or higher, who own a smartphone, and currently exercise rarely or never, might be a good fit. The study lasts 12 weeks and measures changes in weight, activity, and mental health. As an unphased trial, this study offers a unique opportunity to explore new ways to enhance health and well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using or plan to use weight loss medications.

What prior data suggests that this mobile app and fitness tracker are safe for weight management?

Research has shown that mobile wellness apps and fitness trackers are generally safe. Previous studies explored using a smartphone app with a wearable fitness tracker to manage weight and increase physical activity. These studies found no major safety issues, and most participants used the app and tracker without problems.

For the mobile app alone, other studies also reported no major safety concerns. Users generally had a positive experience, and the app helped them manage their weight without harmful effects.

Overall, both the app and the combination with a fitness tracker are well-tolerated. Research has reported no serious side effects, indicating that most people can safely use these tools for weight management and physical activity.12345

Why are researchers excited about this trial?

Researchers are excited about the use of a mobile wellness app combined with a fitness tracker to tackle obesity. Unlike traditional options like diet plans, medication, or surgery, this approach leverages technology to promote healthier habits in real-time. The app offers personalized guidance and feedback, while the fitness tracker provides instant data on activity levels, encouraging users to stay active. This tech-driven method could empower individuals to make sustainable lifestyle changes, which is why it's generating interest.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will evaluate the effectiveness of a mobile wellness app, both with and without a wearable fitness tracker, for weight management. Research has shown that using a mobile wellness app, particularly with a wearable fitness tracker, can aid in weight loss and increase physical activity. One study found that participants using both the app and tracker lost about 1.99 kg (approximately 4.4 pounds) in just three months. Another study discovered that a smartphone app combined with a fitness tracker helped individuals lose weight and become more active over a longer period. Even using the app alone yielded positive results, with users losing some weight and lowering their Body Mass Index (BMI) over several months. Overall, these tools appear effective for managing weight and improving health. Participants in this trial will be assigned to one of three groups: using both the app and tracker, using the app only, or following their normal routines with access to wellness information.13678

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have a BMI of 25 or higher, are not regularly active, own a smartphone, and are willing to use a wellness app (and possibly a fitness tracker) for 12 weeks. Participants must be open to tracking their weight and submitting video recordings.

Inclusion Criteria

I am confident or willing to try participating in this study.
I am 18 years old or older.
* A baseline BMI ≥ 25
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline assessments and are randomized into study arms

1 week

Treatment

Participants use the mobile wellness application, with or without a wearable tracker, for weight management and health outcomes

12 weeks
Remote participation, no in-person visits required

Follow-up

Participants are monitored for weight change, physical activity, and mental health outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • App + Fitness Tracker
  • App Only
  • Control Group

Trial Overview

The study compares three groups: one uses both a mobile wellness app and wearable fitness tracker, another uses just the app, and the third receives standard health info. The goal is to see which approach best supports weight loss, activity levels, and mental well-being over 12 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: App OnlyExperimental Treatment1 Intervention
Group II: App + Fitness TrackerExperimental Treatment1 Intervention
Group III: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BetterMe Limited

Lead Sponsor

Citations

Long-term Effectiveness of a Smartphone App Combined With ...

This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention—combining a smartphone app, ...

Evaluation of a Mobile Wellness Application and Wearable ...

This study will examine whether adding a wearable fitness tracker to a mobile wellness application enhances health outcomes compared with app- ...

The Effectiveness of Combining Nonmobile Interventions With ...

Compared with controls, the use of a smartphone app–based intervention showed a significant weight loss of –1.99 kg (95% CI –2.19 to –1.79 kg; I2=81%) at 3 ...

The effectiveness of mobile app usage in facilitating weight loss

This study demonstrates the effectiveness of engaging with the SIMPLE mobile application in achieving WL in adults with overweight and obesity in a real‐world ...

Smartphone app-based interventions targeting physical ...

This study aimed to explore the efficacy of smartphone app-based interventions targeting physical activity for obesity-related outcomes

Mobile App + Fitness Tracker for Obesity · Info for Participants

Participants will use the interventions over a 12-week period, and outcomes including weight change, activity levels, and self-reported mental ...

Mobile Apps to Improve Health Parameters in Healthy Adults

Recently, mobile health and mobile apps have been proposed as a potential tool to improve different outcomes (eg, daily steps, blood glucose) in ...

Long-term Effectiveness of a Smartphone App Combined ...

Objective: This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an ...