NCT05714280

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

June 28, 2022

Last Update Submit

August 18, 2025

Conditions

Keywords

PA4Health Open PilotPhysical Activity AppAfrican American Women

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Accelerometer

    Participants will wear this device for 7 consecutive days at baseline and at 8 weeks(end of the intervention)

  • Fitbit data

    Participants will wear this device daily during the 8-week intervention

Interventions

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.

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • \) have a valid email address, and 9) no previous engagement in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of New York School of Public Health & Health Policy

New York, New York, 10027, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

February 6, 2023

Study Start

February 25, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations