Smart Walk: A Physical Activity Program for African American Women

Study Overview
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Brief Summary
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The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women.

Detailed Description
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A three-phase study will be used to refine and implement an established theory-based culturally relevant physical activity promotion intervention for obese African American women. Phase 1 (Aim 1a) will include formative research where 25 African American women provide feedback (via 9 focus groups) to further refine the physical activity intervention by specifying the deep structure cultural relevance of the theoretical mediators of self-regulation, self-efficacy, social support, behavioral capability, and outcome expectations.5 Phase 2 will focus on technical development of the refined culturally tailored intervention and 1-month demonstration trial of the Smartphone-delivered physical activity promotion program. Phase 3 (Aims 1b and 1c) will test the intervention and delivery strategy in a two-arm randomized trial where 60 sedentary, obese African American women will receive either the 8-month culturally relevant smartphone-delivered physical activity intervention or a 8-month wellness contact control condition

Official Title
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Smart Walk: A Physical Activity Program for African American Women

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Physical Activity
* Behavioral: Wellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported African American Insufficiently Active ( 60 mins or less of PA per wk measured by Exercise Vital Sign Questionnaire) BMI>30 English speaking and reading Own non-Kindle Smartphone iOS 7 or above, or Android 2.3 or above Exclusion Criteria: Concurrent participation in another physical activity, nutrition, or weight loss program Endorsement of an item on the Physical Activity Readiness Questionnaire (PAR-Q) unless physical note is provided Pregnant or plans to become pregnant in next 12 months Plans to relocate out of Phoenix area in next 12 months

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity<br>A culturally relevant physical activity promotion program delivered using a Smartphone application. | Behavioral: Physical Activity<br>* A Smartphone delivered physical activity program<br>|
| Active Comparator: Wellness Contact Control<br>A wellness contract control condition delivered using a Smartphone application. | Behavioral: Wellness<br>* A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity from baseline to 8-months | assessed by ActiGraph accelerometers | three assessment periods: baseline, 4-months, and 8-months | 
| Feasibility and acceptability of the Smartphone delivered physical activity program | Feasibility and acceptability will be assessed by examining recruitment, retention, adherence, self-reported treatment acceptance, and participant utilization of the Smartphone application provided by analytic tracking software. | 4-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body mass index (BMI) from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in cardiorespiratory fitness from baseline to 8-months | A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak). | three assessment periods: baseline, 4-months, and 8-months | 
| change in Aortic Pulse Wave Velocity from baseline to 8-months | A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology | three assessment periods: baseline, 4-months, and 8-months | 
| change in blood pressure from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in total serum cholesterol from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in serum high-density lipoprotein (HDL) from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in serum low-density lipoprotein (LDL) from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in serum triglycerides from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in serum insulin from baseline to 8-months | measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics) | three assessment periods: baseline, 4-months, and 8-months | 
| change in insulin sensitivity from baseline to 8-months | assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405. | three assessment periods: baseline, 4-months, and 8-months | 
| change in tumor necrosis factor alpha from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 
| change in Interleukin 1 beta from baseline to 8-months |  | three assessment periods: baseline, 4-months, and 8-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, overweight, obese, exercise, women, African American, Smartphone, cardiovascular disease risk