FitBros App for Exercise Engagement

Enrolling by invitation at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called FitBrothers, designed to help African American men begin and maintain regular physical activity. The app sends reminders, tracks progress, and offers tailored motivational messages. To evaluate its effectiveness, the trial compares FitBrothers with the Nike Training Club app. The trial seeks African American men who are at least 30 years old, have a BMI (a measure of body fat) between 18.5 and 45, and are currently not very active. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance health and fitness in the community.

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 prior data suggests that the FitBrothers app is safe for increasing physical activity in African American men?

Research shows that the FitBrothers app helps African American men become more active and maintain their activity levels. However, specific safety information for the FitBrothers app is not available. Fitness apps like FitBrothers can raise concerns about data privacy and security because they store personal information. Users should exercise caution, particularly regarding online threats such as phishing (attempts to steal personal information) and malware (harmful software). While the app encourages healthy habits, understanding how to protect personal information when using these apps is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FitBrothers smartphone app is unique because it offers a tailored exercise engagement experience specifically developed with input from African American men. Unlike other fitness apps like Nike Training Club, FitBrothers not only helps track physical activity but also incorporates health monitoring, such as blood pressure and blood glucose levels. Researchers are excited about this app because it adapts to user behavior with personalized prompts and goals, potentially leading to better long-term fitness outcomes and adherence.

What evidence suggests that the FitBrothers app is effective for increasing physical activity in African American men?

Research has shown that the FitBrothers app, available to participants in this trial, can help African American men become more active and maintain that activity. The app employs strategies proven to encourage a more active lifestyle. Its game-like features, which have increased user interest and activity levels, make the FitBrothers app special. Additionally, input from African American men guided its creation to meet their specific needs and preferences. This personalized approach makes it promising for encouraging long-term physical activity. Meanwhile, another group in this trial will use the Nike Training Club app, which offers fitness tracking and personalized plans but was not specifically developed with input from African American men. ^{2 6 7 8 9}

Who Is on the Research Team?

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/nct05621044

Physical Activity Smartphone App for African American Men ... 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 ...

2. reporter.nih.gov reporter.nih.gov/search/mzBu__Vkv0m_bdkYGZDxVw/project-details/10691385

Smartphone App to Increase and Maintain Physical Activity in ... Behavioral interventions have proven to be effective in promoting increases in physical activity. While behavior change programs have been shown to assist ...

3. withpower.com withpower.com/trial/fitbros-app-for-exercise-engagement-6ef63

FitBros App for Exercise Engagement · Info for Participants The FitBrothers app is unique because it likely incorporates gamification features, which have been shown to enhance user engagement and increase physical ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05621044/physical-activity-smartphone-app-for-african-american-men-fitbros-ph-ii

Physical Activity Smartphone App for African American ... The FitBrothers app was developed through a Phase I consisting of (1) iterative focus groups, (2) developing a conceptual model, and (3) ...

5. bohrium.com bohrium.com/paper-details/a-focus-group-study-among-insufficiently-physically-active-african-american-adults-regarding-technology-delivered-team-based-gamification-for-physical-activity-promotion/977543441711890442-43987

A focus group study among insufficiently physically active African ... A focus group study among insufficiently physically active African American adults regarding technology-delivered team-based gamification for physical activity ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05621044

Physical Activity Smartphone App for African American ... The FitBrothers smartphone active app is designed to assist African American men with adopting and maintaining PA. The app will be developed with significant ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000207566

Determinants of Inequities in Neurologic Disease, Health, ... Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers). NIH R42 Funded by the National Institute on ...

8. reporter.nih.gov reporter.nih.gov/project-details/9271229

MI-BP: mHealth to Improve Blood Pressure Control in ... Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) ... safety, and reduce cardiovascular risk. 442, 1K01HL175188 ...

9. elevaterope.com elevaterope.com/blogs/articles/fitness-apps-by-cyber-threats?srsltid=AfmBOoruwnFssXjyZA_yXHmsSIKHCzbBuclbpNrA7ST_J7hRN3WUg3S3

Fitness Apps and Cyber Threats: 5 Ways to Protect Yourself Fitness apps store sensitive data and face cyber threats like phishing and malware. Learn how to stay safe and protect your privacy.