MedPath

Smart Walk: A Physical Activity Program for African American Women

Not Applicable
Completed
Conditions
Physical Activity
Interventions
Behavioral: Physical Activity
Behavioral: Wellness
Registration Number
NCT02823379
Lead Sponsor
Arizona State University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
62
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Physical ActivityPhysical ActivityA culturally relevant physical activity promotion program delivered using a Smartphone application.
Wellness Contact ControlWellnessA wellness contract control condition delivered using a Smartphone application.
Primary Outcome Measures
NameTimeMethod
Feasibility and acceptability of the Smartphone delivered physical activity program4-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.

Change in physical activity from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months

assessed by ActiGraph accelerometers

Secondary Outcome Measures
NameTimeMethod
change in Aortic Pulse Wave Velocity from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months

A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology

change in blood pressure from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in serum triglycerides from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in body mass index (BMI) from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in total serum cholesterol from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in serum low-density lipoprotein (LDL) from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in serum insulin from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months

measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics)

change in tumor necrosis factor alpha from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in Interleukin 1 beta from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in serum high-density lipoprotein (HDL) from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months
change in insulin sensitivity from baseline to 8-monthsthree 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 cardiorespiratory fitness from baseline to 8-monthsthree assessment periods: baseline, 4-months, and 8-months

A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak).

Trial Locations

Locations (1)

Rodney P. Joseph

🇺🇸

Phoenix, Arizona, United States

© Copyright 2025. All Rights Reserved by MedPath