Clinical trial NCT02823379: Smart Walk: A Physical Activity Program for African American Women
Official title: Smart Walk: A Physical Activity Program for African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
overweight
obese
exercise
women
African American
Smartphone
cardiovascular disease risk
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-07-06
Enrollment: 62
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: Feasibility and acceptability of the Smartphone delivered physical activity program
timeFrame: 4-months
Secondary outcomes:
measure: change in body mass index (BMI) from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in cardiorespiratory fitness from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in Aortic Pulse Wave Velocity from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in blood pressure from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in total serum cholesterol from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in serum high-density lipoprotein (HDL) from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in serum low-density lipoprotein (LDL) from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in serum triglycerides from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in serum insulin from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in insulin sensitivity from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in tumor necrosis factor alpha from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
measure: change in Interleukin 1 beta from baseline to 8-months
timeFrame: three assessment periods: baseline, 4-months, and 8-months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Rodney P. Joseph
state: Arizona
Study officials:
References:
citation: Joseph RP, Ainsworth BE, Vega-Lopez S, Adams MA, Todd M, Gaesser GA, Keller C. Cardiometabolic Risk Factors Among Insufficiently Active African American Women With Obesity: Baseline Findings From Smart Walk. J Cardiovasc Nurs. 2023 Mar-Apr 01;38(2):198-204. doi: 10.1097/JCN.0000000000000930. Epub 2022 Jul 5.
citation: Joseph RP, Ainsworth BE, Mathis L, Hooker SP, Keller C. Incorporating religion and spirituality into the design of community-based physical activity programs for African American women: a qualitative inquiry. BMC Res Notes. 2017 Oct 23;10(1):506. doi: 10.1186/s13104-017-2830-3.