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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
Smart 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).
This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.
Arizona State University
Phoenix, Arizona, United States
RECRUITINGChange in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 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
Time frame: Assessed at baseline, 4-months, 12-months
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
Assessed by the 7-Day Physical Activity Recall
Time frame: Assessed at baseline, 4-months, 12-months
Change in cardiorespiratory fitness from baseline to 4- and 12-months
A modified Balke treadmill protocol will be used to estimate maximal aerobic capacity (i.e., VO2 peak).
Time frame: Assessed at baseline, 4-months, 12-months
Change in aortic pulse wave velocity from baseline to 4- and 12-months
A measure of aortic stiffness and will be assessed using SphygmoCor XCEL system using validated methodology.
Time frame: Assessed at baseline, 4-months, 12-months
Change in body weight from baseline to 4- and 12-months.
Measured in kilograms using an electronic scale
Time frame: Assessed at baseline, 4-months, 12-months
Change in body mass index from baseline to 4- and 12-months
Calculated using the formula: weight (in kilograms) / height (in meters)squared
Time frame: Assessed at baseline, 4-months, 12-months
Change in waste circumference from baseline to 4- and 12-months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measured in centimeters
Time frame: Assessed at baseline, 4-months, 12-months
Change in blood pressure (mmHG) from baseline to 4- and 12-months
Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest
Time frame: Assessed at baseline, 4-months, 12-months
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months
Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Time frame: Assessed at baseline, 4-months, 12-months
Change in interleukin 6 (IL-6) from baseline to 4- and 12-months
Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Time frame: Assessed at baseline, 4-months, 12-months
Change in interleukin 10 (IL-10) from baseline to 4- and 12-months
Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Time frame: Assessed at baseline, 4-months, 12-months
Change in interleukin 15 (IL-15) from baseline to 4- and 12-months
Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.
Time frame: Assessed at baseline, 4-months, 12-months
Change in fasting blood glucose glucose from baseline to 4- and 12-months
Plasma glucose assessed after a 10 hour fasting blood draw. Measured using an automated chemistry analyzer.
Time frame: Assessed at baseline, 4-months, 12-months
Change in serum insulin from baseline to 4- and 12-months
Serum insulin collected after a 10 hour fasting blood draw.
Time frame: Assessed at baseline, 4-months, 12-months
Change in serum lipids (mg/DL) from baseline to 4- and 12-months
Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
Time frame: Assessed at baseline, 4-months, 12-months
Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months
Assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405.
Time frame: Assessed at baseline, 4-months, 12-months
Change in exercise self-efficacy from baseline to 4- and 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.
Time frame: Assessed at baseline, 4-months, 12-months
Change in self-regulation for physical activity from baseline to 4- and 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.
Time frame: Assessed at baseline, 4-months, 12-months
Change in social support for physical activity from baseline to 4- and 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.
Time frame: Assessed at baseline, 4-months, 12-months
Change in outcome expectations for physical activity from baseline to 4- and 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.
Time frame: Assessed at baseline, 4-months, 12-months
Change in behavioral capability for physical activity from baseline to 4- and 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.
Time frame: Assessed at baseline, 4-months, 12-months