Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart Walk, Fitbit.
- Who it may be relevant to
- Registry conditions: Physical Activity, Exercise, Heart Diseases, Diabetes Mellitus. Basic parameters: 24 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Overview
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.
Interventions
- Behavioral Smart Walk
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 - Behavioral Fitbit
This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.
Primary outcome measures
- Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months [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 [Time frame: Assessed at baseline, 4-months, 12-months]
Secondary outcome measures (12)
- Change in cardiorespiratory fitness from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in aortic pulse wave velocity from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in body weight from baseline to 4- and 12-months. [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in body mass index from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in waste circumference from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in blood pressure (mmHG) from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 6 (IL-6) from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 10 (IL-10) from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 15 (IL-15) from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in fasting blood glucose glucose from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
- Change in serum insulin from baseline to 4- and 12-months [Time frame: Assessed at baseline, 4-months, 12-months]
Eligibility criteria
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Arizona State University — Phoenix
Identifiers
NCT: NCT06337708 · STUDY00017286 · R01HL168170