Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age24-65
SponsorArizona State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 > 25 kg/m2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smart Walk
BehavioralSmart 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).
Fitbit
BehavioralThis intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Smart WalkExperimental treatment 1 intervention
Group B: FitbitActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-months2
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-monthsSecondary outcomes
1
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-months2
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-months3
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-months4
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-monthsOther outcomes
1
Treatment acceptance
Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
Time frame
Assessed at 4-months and 12-months2
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-months3
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-months4
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-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov