FitBros App for Exercise Engagement

Recruiting at 2 trial locations

Overseen By Amanda Brice

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Klein Buendel, Inc.

Disqualifiers: Exercise-preventing conditions, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Low physical activity levels contribute to African American men experiencing health disparities across a number of chronic diseases. Studies have been effective in increasing physical activity levels in African American men; but few have targeted maintenance of behavior change and none have utilized emerging technologies. The purpose of the current study is to further develop a mobile phone application for African American men that will help them initiate and maintain their physical activity levels.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the FitBrothers smartphone active app, Nike Training Club treatment?

Research shows that smartphone apps can help people stay active after rehabilitation, with some studies indicating that app users tend to maintain higher activity levels in the short term. Additionally, mobile apps and activity trackers with self-monitoring features have been found to effectively increase physical activity in adults. ^{1 2 3 4 5}

Is the FitBros App safe for use in humans?

The research does not provide specific safety data for the FitBros App or similar apps like the Nike Training Club. However, wearable activity trackers, in general, are considered safe and are widely used to increase physical activity without significant safety concerns. ^{3 6 7 8 9}

How is the FitBrothers smartphone app treatment different from other exercise engagement treatments?

The FitBrothers app is unique because it likely incorporates gamification features, which have been shown to enhance user engagement and increase physical activity levels. This approach is different from traditional exercise programs as it uses game-like elements to motivate users, making the exercise experience more enjoyable and engaging. ^{10 11 12 13 14}

Research Team

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for African American men who are at least 30 years old, have a BMI between 18.5 and 45, can safely do aerobic and resistance training, don't exercise regularly, own a smartphone, and agree to participate. Men with medical conditions that prevent regular exercise or deemed unsuitable by the investigators cannot join.

Inclusion Criteria

I am an African American male.

I am 30 years old or older.

BMI > 18.5 kg/m2 and < 45 kg/m2

Exclusion Criteria

Conditions that the medical or principal investigator determine to warrant exclusion

Unwilling to give written informed consent

Conditions that prevent regular exercise

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Development and Usability Testing

Development of the full-scale FitBrothers app and conducting usability testing

3 months

Comparative Effectiveness Trial

Conducting a trial to assess the effectiveness of the FitBrothers app compared to a similar app

9 months

Follow-up

Participants are monitored for changes in physical activity, dietary habits, weight, blood pressure, and quality of life

9 months

Treatment Details

Interventions

• FitBrothers smartphone active app
• Nike Training Club

Trial Overview The study is testing a mobile phone app called FitBrothers designed to help African American men start and keep up with physical activity. It's compared against another app called Nike Training Club to see which one works better for maintaining health behaviors through technology.

Participant Groups

Group I: FitBrothers smartphone active app Experimental Treatment 1 Intervention

Participants will be expected to engage with the FitBrothers app on a daily basis. Daily alerts and notifications will engage users in daily use of the app and provide up-to-date information on users' progress. Participant responses will also be used to evaluate additional or on-going support of users' needs (e.g., increase/ decrease prompts based on user preferences, tailored messages around a set goal, etc.). To protect privacy and to ensure that the participant is the person completing the app activities, KB will uniquely identify the user's smartphone based off the device's "hardware footprint". The app will upload all app activity data to the KB secured web server database.

Group II: Comparator app Active Control 1 Intervention

Nike Training Club is a free app available on iOS and Android platforms. The app is designed to increase fitness in users through a variety of mechanisms. Similar to FitBrothers, men will be able to track and monitor their physical activity level, set goals, engage in competitions, and upload activity data from a wearable. They will also be provided with preset workouts, receive guidance from an expert, and receive personalized plans that automatically adapt to user behavior. Unlike the FitBrothers app, the Nike Training Club app was not developed with input from African American men, does not track health information (e.g. blood pressure, blood glucose), does not have a theoretical basis, and does not have specific strategies for maintenance.

Who Is Running the Clinical Trial?

Klein Buendel, Inc.

Lead Sponsor

Trials

41

Recruited

20,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Findings from Research

A systematic review of 35 studies involving 7454 participants found that mobile app and tracker interventions led to a small-to-moderate increase in physical activity, equating to an average of 1850 additional steps per day.

Interventions that included text messaging and personalized features were particularly effective, suggesting that these elements enhance user engagement and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. Laranjo, L., Ding, D., Heleno, B., et al.[2021]

In a study of 616 low-income, majority Latina patients with obesity, one in three participants did not meet the step count criterion for valid Fitbit wear, highlighting challenges in using wearable activity monitors for accurate physical activity assessment.

Barriers such as older age, higher BMI, smartphone use issues, and negative emotional responses were identified as predictors of invalid data collection, suggesting that these factors need to be addressed to improve the effectiveness of wearable activity monitors in weight-loss interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Valid Activity Monitor Data: A Multimethod Analysis of Weight-Loss Intervention Participants' Barriers to Wear and First 100 Days of Physical Activity. Orstad, SL., Gerchow, L., Patel, NR., et al.[2022]

In a study of 67 overweight and obese adults using the Fitbit One for 6 weeks, participants showed a significant increase in moderate- to vigorous-intensity physical activity (MVPA) by 4.3 minutes per week, indicating that self-monitoring can enhance physical activity levels.

The addition of SMS text prompts initially boosted physical activity, leading to an increase of 1,266 steps and 17.8 minutes of MVPA in the intervention group, but this effect diminished after one week, suggesting that while prompts can be effective, their impact may be short-lived.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensor/Device (Fitbit One) and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight and Obese Adults: A Randomized Controlled Trial. Wang, JB., Cadmus-Bertram, LA., Natarajan, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

App-based supplemental exercise in rehabilitation, adherence, and effect on outcomes: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Can mobile-health applications contribute to long-term increase in physical activity after medical rehabilitation?-A pilot-study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Covertly Measured Home Exercise Adherence on Patient Outcomes Among Older Adults With Chronic Knee Pain. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Defining Valid Activity Monitor Data: A Multimethod Analysis of Weight-Loss Intervention Participants' Barriers to Wear and First 100 Days of Physical Activity. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Validity and Reliability of Fitbit Flex for Step Count, Moderate to Vigorous Physical Activity and Activity Energy Expenditure. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Smartphones and tooth brushing: content analysis of the current available mobile health apps for motivation and training. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Gamification in a Physical Activity App: What Gamification Features Are Being Used, by Whom, and Does It Make a Difference? [2022]

12. England pubmed.ncbi.nlm.nih.gov

Simulated Partners and Collaborative Exercise (SPACE) to boost motivation for astronauts: study protocol. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Wearable Sensor/Device (Fitbit One) and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight and Obese Adults: A Randomized Controlled Trial. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Quality assessment of smartphone fitness apps used to increase physical activity level and improve general health in adults: A systematic review. [2022]