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Active, not recruitingNCT07114900PA4HealthRCTUpdated Sep 3, 2025

Randomized Controlled Physical Activity App Intervention for Black Women

A Phase 3 interventional study of PA4Health app physical activity intervention and Wellness Text Messaging Program in Physical Activity, sponsored by Stony Brook University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Stony Brook University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as active, not recruiting.
  • Registered 4 months after the study started (first participant enrolled Mar 2025, registered Jul 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Physical Activity

Browse trials for

Keywords

  • Physical activity app, Wellness Text messaging, RCT
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Behavioral: PA4Health app physical activity intervention

    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

    Behavioral: PA4Health app physical activity intervention

  • Active comparator
    Wellness Text Messaging

    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.

    Behavioral: Wellness Text Messaging Program

Interventions

  • BehavioralPA4Health app physical activity intervention

    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

    Also known as: Behavioral PA4Health app physical activity intervention, PA4Health

  • BehavioralWellness Text Messaging Program

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: End of 8 weeks

  2. 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

    Time frame: 8 weeks

Secondary outcomes

  1. Accelerometer/actigraph data

    Actigraph data will be analyzed to explore potential changes over time objectively collected min/week of MVPA

    Time frame: baseline, 8 weeks, 6-month follow-up

  2. 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.

    Time frame: baseline, 8 weeks, 6-month follow-up

  3. Fitbit data

    Fitbit data will be explored to estimate the effect of the intervention on mean steps/week over time

    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

07

Study locations

1 site
  • Stony Brook University
    Stony Brook, New York 11794, United States
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07114900
Lead sponsor
Stony Brook University
Responsible party
Marie Aline Sillice, PHD (Assistant Professor, Stony Brook University) — Principal investigator
First posted
Aug 11, 2025
Start date
Mar 9, 2025
Primary completion
May 18, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 3, 2025

Study contacts

Marie Aline Sillice, PHD
principal investigator · Stony Brook University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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