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Clinical Trials/NCT02823379
NCT02823379CompletedNot Applicable

Smart Walk: A Physical Activity Program for African American Women

Arizona State University1 site in 1 country62 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Feasibility and acceptability of the Smartphone delivered physical activity program

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
24 Years to 49 Years (Adult)
Sex
Female
Accepts 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)
  • •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

Arms & Interventions

Physical Activity

Experimental

A culturally relevant physical activity promotion program delivered using a Smartphone application.

Intervention: Physical Activity (Behavioral)

Wellness Contact Control

Active Comparator

A wellness contract control condition delivered using a Smartphone application.

Intervention: Wellness (Behavioral)

Outcomes

Primary Outcomes

Feasibility and acceptability of the Smartphone delivered physical activity program

Time Frame: 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.

Change in physical activity from baseline to 8-months

Time Frame: three assessment periods: baseline, 4-months, and 8-months

assessed by ActiGraph accelerometers

Secondary Outcomes

  • change in Aortic Pulse Wave Velocity from baseline to 8-months(three assessment periods: baseline, 4-months, and 8-months)
  • change in blood pressure 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)
  • change in body mass index (BMI) 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 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)
  • 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 insulin sensitivity 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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