Skip to main content
Clinical Trials/NCT07114900
NCT07114900Active, not recruitingPhase 3

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

Stony Brook University1 site in 1 country50 target enrollmentStarted: March 9, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Enrollment
50
Locations
1
Primary Endpoint
System Usability Scale (SUS)--app satisfaction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
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

  • •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

Arms & Interventions

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

Intervention: PA4Health app physical activity intervention (Behavioral)

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.

Intervention: Wellness Text Messaging Program (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie Aline Sillice, PHD

Assistant Professor

Stony Brook University

Study Sites (1)

Loading locations...

Similar Trials