PA4Health Physical Activity App Open Pilot Study for African American Women

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

Test the acceptability of a smartphone physical activity app for African American women

Study Overview

• Status: Active, not recruiting
• Conditions: Test Acceptability/Usability of a Physical Activity App Developed for African American Women
• Intervention / Treatment: Behavioral: PA4Health Open Pilot

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • City University of New York School of Public Health & Health Policy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion: Eligible participants must:

1. be ages 18-64
2. identify as AA and female
3. own a smartphone
4. be able to provide consent
5. 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:

1. physical limitations to PA engagement
2. significant medical conditions (e.g., heart failure)
3. planned surgery in the next 6 months,
4. pregnant or plan to become pregnant in the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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.	8 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	8weeks

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 8 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 8-week intervention

Collaborators and Investigators

• Sponsor: City University of New York, School of Public Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: African American Women; PA4Health Open Pilot; Physical Activity App
• Other Study ID Numbers: CityUNYSPH; K23MD014164 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No