Randomized Controlled Physical Activity App Intervention for Black Women

NCT ID: NCT07114900

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-09
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PA4Health app physical activity intervention

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Wellness Text Messaging Program

Intervention Type: 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.

Interventions

PA4Health 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

Intervention Type: BEHAVIORAL

Wellness 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavioral PA4Health app physical activity intervention; PA4Health

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Marie Aline Sillice, PHD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Aline Sillice, PHD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

Other Identifiers

K23MD014164

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RB2023-00444

Identifier Type: OTHER

Identifier Source: secondary_id

PA4Health RCT

Identifier Type: -

Identifier Source: org_study_id