Overview

This trial is active, not recruiting.

Condition physical activity
Treatments physical activity, wellness
Sponsor Arizona State University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2015
End date June 2020
Trial size 113 participants
Trial identifier NCT02823379, K99HL129012, STUDY00003131

Summary

The purpose of this project is to test a 12-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
A culturally relevant physical activity promotion program delivered using a Smartphone application.
physical activity
A Smartphone delivered physical activity program
(Active Comparator)
A wellness contract control condition delivered using a Smartphone application.
wellness
A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., sleep hygiene, oral health, and breast exams).

Primary Outcomes

Measure
Change in physical activity from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months

Secondary Outcomes

Measure
change in body mass index (BMI) from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in cardiorespiratory fitness from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in Aortic Pulse Wave Velocity from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in blood pressure from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in total serum cholesterol from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in serum high-density lipoprotein (HDL) from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in serum low-density lipoprotein (LDL) from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in serum triglycerides from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in serum insulin from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in insulin sensitivity from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in tumor necrosis factor alpha from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months
change in Interleukin 1 beta from baseline to 12-months
time frame: four assessment periods: baseline, 3 months, 6-months, and 12-months

Eligibility Criteria

Female participants from 24 years up to 49 years old.

Inclusion Criteria: - Self-reported African American - Insufficiently Active (< 60 mins 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) - Pregnant or plans to become pregnant in next 12 months - Plans to relocate out of Phoenix area in next 12 months

Additional Information

Official title Smart Walk: A Physical Activity Program for African American Women
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 6-month culturally relevant smartphone-delivered physical activity intervention or a 6-month wellness contact control condition
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Arizona State University.