Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
- Conditions
- Diabetes MellitusHeart DiseasesPhysical InactivityPhysical ActivityExercise
- Interventions
- Behavioral: FitbitBehavioral: Smart Walk
- Registration Number
- NCT06337708
- Lead Sponsor
- Arizona State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fitbit Fitbit Participants will receive a Fitbit Inspire 3 activity monitor. Smart Walk Smart Walk Participants will receive a culturally tailored smartphone-delivered physical activity intervention.
- Primary Outcome Measures
Name Time Method Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months 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 Assessed at baseline, 4-months, 12-months Assessed by the 7-Day Physical Activity Recall
- Secondary Outcome Measures
Name Time Method Change in cardiorespiratory fitness from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months A modified Balke treadmill protocol will be used to estimate maximal aerobic capacity (i.e., VO2 peak).
Change in waste circumference from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Measured in centimeters
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Change in interleukin 6 (IL-6) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Change in interleukin 10 (IL-10) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Change in serum insulin from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Serum insulin collected after a 10 hour fasting blood draw.
Change in blood pressure (mmHG) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest
Change in self-regulation for physical activity from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed by the 10- item Self-Regulation Scale from the Health Beliefs Survey (Anderson-Bill 2006). This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.
Change in aortic pulse wave velocity from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months A measure of aortic stiffness and will be assessed using SphygmoCor XCEL system using validated methodology.
Change in body weight from baseline to 4- and 12-months. Assessed at baseline, 4-months, 12-months Measured in kilograms using an electronic scale
Change in behavioral capability for physical activity from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed using a 6-item scale developed by the research team in previous research. The range of possible scores for this measure is 1-6, with higher scores indicating higher levels of behavioral capability of physical activity.
Change in body mass index from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Calculated using the formula: weight (in kilograms) / height (in meters)squared
Change in serum lipids (mg/DL) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
Change in exercise self-efficacy from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.
Change in interleukin 15 (IL-15) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Change in fasting blood glucose glucose from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Plasma glucose assessed after a 10 hour fasting blood draw. Measured using an automated chemistry analyzer.
Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405.
Change in social support for physical activity from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed by the Social Support for Exercise survey developed by Sallis et al (1987). This scale assesses social support from family support (10-items, with a possible range of scores from 10-50) and friends (8-items, with a possible score range from from 8-40). Higher scores indicate greater levels of social support.
Change in outcome expectations for physical activity from baseline to 4- and 12-months Assessed at baseline, 4-months, 12-months Assessed using the 9-item Outcome Expectation Scale for Exercise scale, developed by Resnick (2000). The range of possible scores for this measure is 1-5, with higher scores indicating more positive expectancies associated with physical activity engagement.
Trial Locations
- Locations (1)
Arizona State University
🇺🇸Phoenix, Arizona, United States