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

Arizona State University (ASU)

Status and phase: Enrolling; Phase 2

Conditions: Physical Inactivity; Physical Activity; Diabetes Mellitus; Heart Diseases; Exercise

Treatments: Behavioral: Smart Walk; Behavioral: Fitbit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06337708

STUDY00017286

R01HL168170 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 24 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-reported African American/Black female
• Aged of 24-65 years
• Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
• BMI > 30 kg/m2
• English speaking and reading
• Ownership of a smartphone with the ability to download applications (i.e., apps)
• Ownership of a smartphone with the ability to receive text messages
• Willingness to receive a physical activity intervention delivered through their smartphone
• Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app

Exclusion criteria

• Plans to relocate out of Phoenix area in next 12 months
• Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
• Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
• Self-reported participation in another diet or weight loss study at screening
• Pregnant or planning to become pregnant in the next 12 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Smart Walk

Experimental group

Description:

Participants will receive a culturally tailored smartphone-delivered physical activity intervention.

Treatment:

Behavioral: Smart Walk

Fitbit

Active Comparator group

Description:

Participants will receive a Fitbit Inspire 3 activity monitor.

Treatment:

Behavioral: Fitbit