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临床试验/NCT02823379
NCT02823379已完成不适用

Smart Walk: A Physical Activity Program for African American Women

Arizona State University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Feasibility and acceptability of the Smartphone delivered physical activity program

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Physical Activity

Experimental

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

干预措施: Physical Activity (Behavioral)

Wellness Contact Control

Active Comparator

A wellness contract control condition delivered using a Smartphone application.

干预措施: Wellness (Behavioral)

结局指标

主要结局

Feasibility and acceptability of the Smartphone delivered physical activity program

时间窗: 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

时间窗: three assessment periods: baseline, 4-months, and 8-months

assessed by ActiGraph accelerometers

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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