Arizona State University
Phoenix, Arizona, 85004, United States
Location status: Recruiting
Location contact
Carina Platte, PhD
CONTACT
Rodney Joseph, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06337708
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.
Interested in participating?
Request Info24 year–65 year
Female
Interventional
Phase 2
Phoenix, Arizona, 85004, United States
Location status: Recruiting
Carina Platte, PhD
CONTACT
Rodney Joseph, PhD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Assessed at baseline, 4-months, 12-months
Assessed by the 7-Day Physical Activity Recall
Time frame: Assessed at baseline, 4-months, 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
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
Measured in kilograms using an electronic scale
Time frame: Assessed at baseline, 4-months, 12-months
Calculated using the formula: weight (in kilograms) / height (in meters)squared
Time frame: Assessed at baseline, 4-months, 12-months
Measured in centimeters
Time frame: Assessed at baseline, 4-months, 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
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
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
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
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
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
Serum insulin collected after a 10 hour fasting blood draw.
Time frame: Assessed at baseline, 4-months, 12-months
Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
Time frame: Assessed at baseline, 4-months, 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
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
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
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
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
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 4-months and 12-months
Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
Time frame: Assessed at 4-months and 12-months
Fitbit wear, app utilization, and adherence to physical activity coaching session protocols will be assessed as moderators.
Time frame: Assessed at 4-months and 12-months
Costs borne by the program, including Fitbit activity monitors, Smart Walk app development, and all personnel salaries/hourly wages.
Time frame: Assessed at 4-months and 12-months
Participant costs associated with study participation, including time spent using the Smart Walk app, time spent in physical activity coaching, and cellular phone data charges over their plan limit.
Time frame: Assessed at 4-months and 12-month
Cost effectiveness will be evaluated by combining the mean total cost per participant with effectiveness (baseline to 12-month changes in minutes/week of moderate-to-vigorous physical activity). We will calculate the incremental cost effectiveness ratios (ICER) for the Smart Walk intervention compared to the Fitbit comparison arm.
Time frame: Assessed at baseline
GIS mapping and computer vision techniques will be used to assess macro-scale and micro-scale home neighborhood environment characteristics of participants.
Time frame: Assessed at baseline
Subjectively-measured Neighborhood Environment Walkability will be measured using the Neighborhood Environment Walkability Scale (NEWS). This measure includes 43 items and assesses the following environmental characteristics: residential density (6-items, possible range of scores range 1-5), land use mix-diversity (22 items, possible range of scores range 1-5), street connectivity (2 items, possible range of scores range 1-4), walking/cycling facilities (6 items, possible range of scores range 1-4), aesthetics (4 items, possible range of scores 1-4), pedestrian/traffic safety (3 items, possible range of scores 1-4). Higher scores indicate greater walkability.
Time frame: Assessed at baseline
Race-related stress, as a result of experiencing individual, cultural and institutional racism, will be assessed using the 22-item Index of Race-Related Stress-Brief survey. This survey has a possible score range of 0 to 88, with higher scored indicating greater stress as a result of experiencing racism.
Time frame: Assessed at baseline
Structural racism will be assessed using the 20-item Perceived Structural Racism Scale. This scale has a possible scoring range of 20-120 with higher scores indicating greater levels of perceived structural racism.
Contact information is provided by the study sponsor or research team.
Arizona State University
Other
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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