Test Acceptability/Usability of a Physical Activity App Developed for African American WomenNCT05714280
PA4Health Physical Activity App Open Pilot Study for African American Women
A study testing PA4Health Open Pilot in people with Test Acceptability/Usability of a Physical Activity App Developed for African American Women, run by City University of New York, School of Public Health at 1 site in United States.
Trial summary
Test the acceptability of a smartphone physical activity app for African American women Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Test Acceptability/Usability of a Physical Activity App Developed for African American Women
- What is being tested?
- PA4Health Open Pilot
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
City University of New York School of Public Health & Health Policy
New York, New York, 10027
About this study
Official title: 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
Read the 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.
- Conditions
- Test Acceptability/Usability of a Physical Activity App Developed for African American Women
- Being tested
- PA4Health Open Pilot
- Keywords
- PA4Health Open Pilot, Physical Activity App, African American Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA4Health Open PilotBehavioural
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 8weeks
Secondary outcomes (2)
Accelerometer
actigraph data will be analyzed to explore potential changes over time objectively collected min/week of MVPA
Measured: 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
Measured: Participants will wear this device daily during the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start25 Feb 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test Acceptability/Usability of a Physical Activity App Developed for African American WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714280
- Sponsor's protocol ID
- CityUNYSPH
- Other IDs
- K23MD014164
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Tailored, Theoretically-Driven Smartphone Physical Activity Intervention for African American Women
- ClinicalTrials.gov ID
- NCT05714280
- Acronym / sponsor ID
- CityUNYSPH
- Conditions
- Test Acceptability/Usability of a Physical Activity App Developed for African American Women
- Keywords
- PA4Health Open Pilot, Physical Activity App, African American Women
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test the acceptability of a smartphone physical activity app for African American women
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA4Health Open PilotThe 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. | Behavioural | – |
Primary outcome
System usability scale (SUS)-- app satisfaction
Time frame: 8 weeks study
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.
Metada; collected through app system
Time frame: 8weeks
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
2 secondary outcomes
Accelerometer
Time frame: Participants will wear this device for 7 consecutive days at baseline and at 8 weeks(end of the intervention)
Fitbit data
Time frame: Participants will wear this device daily during the 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA4Health Open Pilot in people with Test Acceptability/Usability of a Physical Activity App Developed for African American Women, run by City University of New York, School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System usability scale (SUS)-- app satisfaction (time frame: 8 weeks study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.