PA4Health Physical Activity App Open Pilot Study for African American Women

Study Overview
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Brief Summary
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Test the acceptability of a smartphone physical activity app for African American women

Detailed Description
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The goal of this aim is to collect data that guide the refinement of intervention components and structure to increase appeal to AA women. Fifteen physically inactive AA women will participate in a 12-week study examining the feasibility, acceptability, and usage of the PA4Health app. They will receive a Fitbit tracker to be worn during the trial. Following the trial, participants will complete self-report measures as well as a semi-structured interview to learn about their experience in using the app, any experienced difficulties, and recommendations for improving the acceptance and usage of the app. Intervention components: The intervention components include: tailored daily text intervention text message, educational feature, goal setting and monitoring, and an activity locator that allow participants to enter their zip code and view available resources for physical activity.

Official Title
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Developing a Tailored, Theoretically-Driven Smartphone Physical Activity Intervention for African American Women

Conditions
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Test Acceptability/Usability of a Physical Activity App Developed for African American Women

Intervention / Treatment
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* Behavioral: PA4Health Open Pilot


Participation Criteria
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Eligibility Criteria
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Inclusion: Eligible participants must: be ages 18-64 identify as AA and female own a smartphone be able to provide consent not regularly physically active (i.e. less than 90 mins. of MVPA per week), 6) medically cleared for PA, 7) have a valid email address, and 9) no previous engagement in the study. Exclusion: Individuals will be excluded if they report: physical limitations to PA engagement significant medical conditions (e.g., heart failure) planned surgery in the next 6 months, pregnant or plan to become pregnant in the next 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: PA4Health Open Pilot|The goal of this aim is to collect data that guide the refinement of intervention components and structure to increase appeal to AA women. Fifteen physically inactive AA women will participate in a 12-week study examining the feasibility, acceptability, and usage of the PA4Health app. They will receive a Fitbit tracker to be worn during the trial. Following the trial, participants will complete self-report measures as well as a semi-structured interview to learn about their experience in using the app, any experienced difficulties, and recommendations for improving the acceptance and usage of the app.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System usability scale (SUS)-- app satisfaction | The SUS measures ability of technology software. High levels of usability and acceptability of the app will be determined by a score greater than 70 on the SUS. Information will be used for improvement of the software. | 12 weeks study | 
| Metada; collected through app system | This information will inform usage of patterns of participants, including how frequently the logged into the app system and the component of the app the more frequently or less frequently | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer | actigraph data will be analyzed to explore potential changes over time objectively collected min/week of MVPA | Participants will wear this device for 7 consecutive days at baseline and at 12 weeks(end of the intervention) | 
| Fitbit data | Fitbit data will be explored to estimate the effect of the intervention on mean steps/week over time | Participants will wear this device daily during the 12-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PA4Health Open Pilot, Physical Activity App, African American Women