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RecruitingNCT06337708

Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
Arizona State University · Academic / Other
Sex
Female
Age
24 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.

Detailed description

This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk. African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines. This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period. Specific Aims: 1. Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group. 2. Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group. 3. Compare cost and cost effectiveness of the two intervention groups from a societal perspective. 4. Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSmart WalkSmart Walk is a culturally tailored, Social Cognitive Theory-based multi-component smartphone delivered physical activity (PA) promotion intervention that delivered through the Smart Walk application, virtual physical activity coaching, and text messages. The Smart Walk smartphone application includes four key features: 1) personal profile pages, 2) culturally relevant multi-media physical activity promotion modules, 3) discussion boards, and 4) physical activity self-monitoring/tracking feature that integrates with Fitbit activity monitors for participants to track their daily, weekly, and monthly activity. Virtual physical activity coaches will actively engage and facilitate group-based dialogue among participants on the app discussion boards and provide individualized, one-on-one PA coaching via telephone or commercially available app-based video teleconferencing software (i.e., FaceTime, Zoom, Google hangouts).
BEHAVIORALFitbitThis intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.

Timeline

Start date
2024-04-08
Primary completion
2027-03-31
Completion
2028-03-31
First posted
2024-03-29
Last updated
2025-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06337708. Inclusion in this directory is not an endorsement.