Randomized Controlled Physical Activity App Intervention for Black Women

NCT07114900 | Active Not Recruiting Phase 3

• 3 other identifiers: PA4Health RCTK23MD014164RB2023-00444
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity

Keywords

Physical activity app, Wellness Text messaging, RCT

Outcome Measures

Primary Outcomes (2)

• 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

  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

  8 weeks

Secondary Outcomes (3)

• Accelerometer/actigraph data

  baseline, 8 weeks, 6-month follow-up

• Physical activity constructs

  baseline, 8 weeks, 6-month follow-up

• Fitbit data

  Participants will wear this device daily during the active phase of the 8-week intervention and also until follow-up/ 6-month follow up

Study Arms (2)

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

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.

Behavioral: Wellness Text Messaging Program

Interventions

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

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

Behavioral: PA4Health app physical activity intervention

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.

Wellness Text Messaging

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Participants identified as female or woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marie Aline Sillice, PHD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 11, 2025
• Study Start: March 9, 2025
• Primary Completion: May 18, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

US (1)