Physical Activity
Conditions
Keywords
physical activity, overweight, obese, exercise, women, African American, Smartphone, cardiovascular disease risk
Brief summary
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
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
Interventions
BEHAVIORALPhysical Activity
A Smartphone delivered physical activity program
BEHAVIORALWellness
A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | assessed by ActiGraph accelerometers |
| Feasibility and acceptability of the Smartphone delivered physical activity program | 4-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | three assessment periods: baseline, 4-months, and 8-months | A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak). |
| change in Aortic Pulse Wave Velocity from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology |
| change in serum low-density lipoprotein (LDL) from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | — |
| change in serum insulin from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics) |
| change in insulin sensitivity from baseline to 8-months | three assessment periods: baseline, 4-months, and 8-months | assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405. |
| 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 | — |
| change in serum high-density lipoprotein (HDL) 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 | — |
Countries
United States
Outcome results
None listed