Physical Activity App for Increasing Physical Activity

(PA4HealthRCT Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Stony Brook University

Disqualifiers: Physical limitations, Heart failure, Surgery, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a physical activity app (PA4Health app) or wellness text messages more effectively encourage Black women to increase their activity levels. The app provides motivational messages, educational topics, and a chatroom for support, while both groups use a Fitbit to track activity. Women who identify as Black, own a smartphone, and engage in less than 90 minutes of moderate exercise per week may be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to research that could soon benefit many others.

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 mainly focuses on your physical activity level and medical clearance for physical activity.

What prior data suggests that the PA4Health app is safe for increasing physical activity?

Research shows that mobile health apps like the PA4Health app can improve exercise habits in both teens and adults. Studies have found that people generally enjoy using these apps, and they rarely cause serious problems. Reviews of similar exercise apps suggest they are safe and help increase activity levels.

This trial tests whether the PA4Health app is more engaging than receiving wellness text messages. Since the trial is in a later stage, earlier studies have likely demonstrated the app's safety. Participants use the app to set goals, track progress, and receive motivational messages, which are common features in health and fitness apps. While the trial is ongoing, existing research suggests the PA4Health app is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PA4Health app because it offers a fresh, tech-driven approach to boosting physical activity. Unlike traditional methods that might rely on just advice or gym sessions, this app integrates personalized goal setting, motivational messaging, and interactive education right at your fingertips. It also features a unique chatroom for peer support and a locator for nearby community resources, making it easier for users to stay active and engaged. This blend of technology and community support could make staying active more accessible and enjoyable for everyone.

What evidence suggests that the PA4Health app is effective for increasing physical activity?

Research has shown that mobile health apps like PA4Health, which participants in this trial may use, can help people become more active. One study found that these apps led to more physical activity than not using any tools. Another review highlighted that mobile apps encourage users to stay active and meet their exercise goals. Staying motivated is crucial for making lasting changes. Overall, evidence suggests that using an app for exercise can increase activity levels and help people remain active. Meanwhile, participants in the trial's Wellness Text Messaging arm will receive daily wellness-related messages as a contact control, which also aims to support physical activity. ^{6 7 8 9 10}

Who Is on the Research Team?

Marie Aline Sillice, PHD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for African American women aged 18-64 who want to be more active but currently exercise less than 90 minutes a week. They must own a smartphone, have an email address, and be medically cleared for physical activity. It's not for those with physical limitations, significant medical conditions like heart failure, upcoming surgeries, or pregnancy plans within six months.

Inclusion Criteria

No previous engagement in the study

I have a valid email address.

I am between 18 and 64 years old.

Exclusion Criteria

I have physical limitations that restrict my ability to engage in physical activities.

Have significant medical conditions (e.g. heart failure)

Be pregnant or plan to become pregnant in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling Session

Participants complete a single counseling session prior to starting the program

1 session

Treatment

Participants engage in an 8-week physical activity intervention using the PA4Health app or receive wellness text messages, with goal setting and monitoring using a Fitbit tracker

8 weeks

3 assessments (baseline, post-intervention, 6 months)

Follow-up

Participants are monitored for changes in physical activity constructs and device data, with assessments at 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PA4Health app

Trial Overview The study compares two methods to increase physical activity: one group uses the PA4Health app designed for workouts while the other receives wellness tips via text messages. The goal is to see which method Black women prefer and stick with more.

How Is the Trial Designed?

Group I: Behavioral: PA4Health app physical activity intervention Experimental Treatment 1 Intervention

The arm for the PA4health app intervention consists of six components: 1) Goal setting and monitoring, 2) Tailored motivational messages based on survey data on barriers and facilitators of physical activity, 3) Education, which consists of twenty-two physical activity (PA) related topics, 4) a semi-structured chatroom where 3-5 participants per chatroom interact with one another to receive and provide peer support for PA, 5) Locator, which provides information about community resources (e.g., community parks, museums) based on participant's zip code, and 6) Steps, which allow participant to monitor their daily level of exercise. Participants wear a Fitbit tracker during the program Edit

Group II: Wellness Text Messaging Active Control 1 Intervention

Participants set goal for PA and are encouraged to monitor their level of physical throughout the program. They receive a daily wellness related message during the program as a contact control. They also wear Fitbit tracker during the program.

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38687568/

Effectiveness of mHealth App-Based Interventions for ... Objective: This study aims to review and analyze the effectiveness of mHealth app-based interventions in promoting PA and improving PF and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892298/

Mobile applications, physical activity, and health promotion This paper studies the role of mobile applications in promoting physical activity and user loyalty to them.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743517305145

Effectiveness of eHealth interventions for the promotion of ... Participation in eHealth interventions to promote PA led to increased levels of PA in adults aged 55 years and above when compared to no intervention control ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(13)00394-2/abstract

Current mHealth Technologies for Physical Activity ... A systematic review of e-health interventions for physical activity: an analysis of study design, intervention characteristics, and outcomes. Telemed J E Health ...

5. researchgate.net researchgate.net/publication/356922808_Effectiveness_of_Social_Media-Based_Interventions_for_the_Promotion_of_Physical_Activity_Scoping_Review

Effectiveness of Social Media-Based Interventions for the ... More than one third of the studies revealed positive effects regarding the promotion of PA. Additionally, social media-based interventions ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07114900

Randomized Controlled Physical Activity App Intervention ... The goal of this study is test whether a physical activity app intervention compared to wellness text messaging intervention is more acceptable/engaging among ...

7. play.google.com play.google.com/store/apps/details?id=com.mooseworkssoftware.pa4health&hl=en

PA4Health - Apps on Google Play PA4Health lets users set goals, report progress, get messages and find resources.

8. withpower.com withpower.com/trial/phase-test-acceptabilityusability-of-a-physical-activity-app-developed-for-african-american-women-1-2023-acfe4

PA4Health Physical Activity App for African American Women This trial is for African American women aged 18-64 who own a smartphone and do not regularly exercise (less than 90 minutes of moderate to vigorous activity ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8339983/

Smartphone-Based Interventions for Physical Activity ... Several reviews of mobile health (mHealth) physical activity (PA) interventions suggest their beneficial effects on behavior change in adolescents and adults.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31858828/

Physical Activity Support Predicts Safety-Net Patients ... Physical activity (PA) counseling predicted knowledge and health apps use. Respondents receiving PA counseling were 2.61 times more likely to be knowledgeable.