Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Physical Activity
- Sponsor
- Arizona State University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
Time Frame: Assessed at baseline, 4-months, 12-months
Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
Time Frame: Assessed at baseline, 4-months, 12-months
Assessed by the 7-Day Physical Activity Recall
Secondary Outcomes
- Change in cardiorespiratory fitness from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in waste circumference from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 6 (IL-6) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 10 (IL-10) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in serum insulin from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in blood pressure (mmHG) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in self-regulation for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in aortic pulse wave velocity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in body weight from baseline to 4- and 12-months.(Assessed at baseline, 4-months, 12-months)
- Change in behavioral capability for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in body mass index from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in serum lipids (mg/DL) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in exercise self-efficacy from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 15 (IL-15) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in fasting blood glucose glucose from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in social support for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in outcome expectations for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)