Physical ActivityPhase 3PA4HealthRCTNCT07114900
Randomized Controlled Physical Activity App Intervention for Black Women
A Phase 3 study testing PA4Health app physical activity intervention and Wellness Text Messaging Program in people with Physical Activity, run by Stony Brook University at 1 site in United States.
Trial summary
The goal of this study is test whether a physical activity app intervention compared to wellness text messaging intervention is more acceptable/engaging among Black women who want to increase their level of physical activity. 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
- Physical Activity
- What is being tested?
- PA4Health app physical activity intervention and Wellness Text Messaging Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2025to 30 Jun 2026
- Phase
- Phase 3
- 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
- Eligible participants were:
- 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,
- medically cleared for PA
- have a valid email address, and 9) no previous engagement in the study.
Who cannot join
- individuals were 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Tailored, Theoretically-Driven Smartphone Physical Activity Intervention for African American Women: RCT
The goal of this study is test whether a physical activity app intervention compared to wellness text messaging intervention is more acceptable/engaging among Black women who want to increase their level of physical activity.
Read the detailed description
The goal of this K23 aim is to examine the acceptability and feasibility of the 8-week PA4Health intervention compared to a general wellness text program with 3 assessments (baseline, post-intervention [8 weeks] and 6 months). Participants will complete a single counseling session prior to starting the program. They complete an objective measure of physical activity by wearing an accelerometer for one week at each assessment time point. During the intervention, they will provided with a Fitbit wrist tracker, that will be synchronized to the app, to be worn during the 8-week intervention. Participants will be able to set goals for physical activity as well as monitor their progress toward achieving their goals. Following the trial, they will complete self-reports survey as well as objective measures of physical activity. They will also complete a single qualitative interview to assess their experience with the intervention and to provide feedback for modification.
- Conditions
- Physical Activity
- Being tested
- PA4Health app physical activity intervention, Wellness Text Messaging Program
- Keywords
- Physical activity app, Wellness Text messaging, RCT
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA4Health app physical activity interventionBehavioural
Also called Behavioral PA4Health app physical activity intervention, PA4Health
PA4Health app intervention Arm Description: During the 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
Wellness Text Messaging ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: PA4Health app physical activity intervention | Experimental | 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 Receives: Behavioral: PA4Health app physical activity intervention |
| Wellness Text Messaging | Active comparator | 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. Receives: Behavioral: Wellness Text Messaging Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)--app satisfaction
Description: 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.
Time Frame: 8 weeks study
Measured: End of 8 weeks
Metada data collected from 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 Time Frame: 8weeks
Measured: 8 weeks
Secondary outcomes (3)
Accelerometer/actigraph data
Actigraph data will be analyzed to explore potential changes over time objectively collected min/week of MVPA
Measured: baseline, 8 weeks, 6-month follow-up
Physical activity constructs
Assess changes in theoretical related constructs for physical activity, Stages of Change, Self-efficacy for Exercise, Physical Activity Enjoyment. Changes in mean scores from baseline to end intervention (8 weeks) will be assessed. Additionally changes in mean scores for these measures from end of intervention (8 weeks) and 6 month follow-up after controlling for baseline will be be explored.
Measured: baseline, 8 weeks, 6-month follow-up
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 active phase of the 8-week intervention and also until follow-up/ 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start9 Mar 2025
- Primary completion18 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Aline Sillice, PHD, Stony Brook University
- Investigators
- Marie Aline Sillice, PHD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114900
- Sponsor's protocol ID
- PA4Health RCT
- Other IDs
- K23MD014164, RB2023-00444
- Acronym
- PA4HealthRCT
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This was not part of the study protocol or informed consent. However, we will consider request to provide that information on an individual basis
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 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: RCT
- ClinicalTrials.gov ID
- NCT07114900
- Acronym / sponsor ID
- PA4HealthRCT / PA4Health RCT
- Conditions
- Physical Activity
- Keywords
- Physical activity app, Wellness Text messaging, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
The goal of this study is test whether a physical activity app intervention compared to wellness text messaging intervention is more acceptable/engaging among Black women who want to increase their level of physical activity.
Detailed description
The goal of this K23 aim is to examine the acceptability and feasibility of the 8-week PA4Health intervention compared to a general wellness text program with 3 assessments (baseline, post-intervention [8 weeks] and 6 months). Participants will complete a single counseling session prior to starting the program. They complete an objective measure of physical activity by wearing an accelerometer for one week at each assessment time point. During the intervention, they will provided with a Fitbit wrist tracker, that will be synchronized to the app, to be worn during the 8-week intervention. Participants will be able to set goals for physical activity as well as monitor their progress toward achieving their goals. Following the trial, they will complete self-reports survey as well as objective measures of physical activity. They will also complete a single qualitative interview to assess their experience with the intervention and to provide feedback for modification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: PA4Health app physical activity intervention | Experimental | Behavioral: PA4Health app physical activity interventionThe 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 |
| Wellness Text Messaging | Active comparator | Behavioral: Wellness Text Messaging ProgramParticipants 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 may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- individuals were 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
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 app physical activity interventionAlso: Behavioral PA4Health app physical activity intervention, PA4HealthPA4Health app intervention Arm Description: During the 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 | Behavioural | Behavioral: PA4Health app physical activity intervention |
| Wellness Text Messaging ProgramParticipants 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. | Behavioural | Wellness Text Messaging |
Primary outcome
System Usability Scale (SUS)--app satisfaction
Time frame: End of 8 weeks
Description: 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. Time Frame: 8 weeks study
Metada data collected from app system
Time frame: 8 weeks
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 Time Frame: 8weeks
3 secondary outcomes
Accelerometer/actigraph data
Time frame: baseline, 8 weeks, 6-month follow-up
Physical activity constructs
Time frame: baseline, 8 weeks, 6-month follow-up
Fitbit data
Time frame: Participants will wear this device daily during the active phase of the 8-week intervention and also until follow-up/ 6-month follow up
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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided. This was not part of the study protocol or informed consent. However, we will consider request to provide that information on an individual basis
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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.
Marie Aline Sillice, PHD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PA4Health app physical activity intervention and Wellness Text Messaging Program in people with Physical Activity, run by Stony Brook University 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 8 inclusion and 5 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 3 Sep 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: End of 8 weeks). 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 3 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.