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Active, Not Recruiting

NCT Number: NCT07114900

Randomized Controlled Physical Activity App Intervention for Black Women

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stony Brook University

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

PA4Health app physical activity intervention

Behavioral

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

Other names: Behavioral PA4Health app physical activity intervention, PA4Health

Wellness Text Messaging Program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Accelerometer/actigraph data

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

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

  2. Physical activity constructs

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

    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.

  3. 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

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

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

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

Acronym: PA4HealthRCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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