A Phase 2 interventional study of Smart Walk and Fitbit in Physical Activity, Exercise and Heart Diseases, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to female participants aged 24 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Arizona State University · Phase 2, Interventional, and Prevention
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:
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 210 is above the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
Compared within Heart Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a culturally tailored smartphone-delivered physical activity intervention.
Behavioral: Smart Walk
Participants will receive a Fitbit Inspire 3 activity monitor.
Behavioral: Fitbit
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.
Change 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
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
Treatment acceptance
Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
Time frame: Assessed at 4-months and 12-months
Protocol Adherence
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
Program costs
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
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-months
Cost-effectiveness
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 4-months and 12-month
Objectively-measured home neighborhood characteristics
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
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
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
Perceived Structural Racism
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.
Time frame: Assessed at baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2028, 47 months after the start.
Of 28 phase 2 interventional studies under Heart Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 49. This study's planned 47 months is above that.
How these figures are worked out, and which studies are left out of them.
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