Physical Activity Clinical Trial
Official title:
Smart Walk: A Physical Activity Program for African American Women
Verified date | July 2020 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 24 Years to 49 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rodney P. Joseph | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in physical activity from baseline to 8-months | assessed by ActiGraph accelerometers | three assessment periods: baseline, 4-months, and 8-months | |
Primary | 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 | change in body mass index (BMI) from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | change in blood pressure from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | change in total serum cholesterol from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | change in serum high-density lipoprotein (HDL) from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | change in serum low-density lipoprotein (LDL) from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | change in serum triglycerides from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | change in tumor necrosis factor alpha from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | ||
Secondary | change in Interleukin 1 beta from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months |
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