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临床试验/NCT00156351
NCT00156351已完成不适用

Evaluation of the National Black Women's Health Project Walking for Wellness Program

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Physical activity level

研究概览

简要总结

The overall purpose of this project is to conduct an innovative, culturally-tailored demonstration project designed to facilitate the adoption and maintenance of regular, moderate physical activity (i.e., brisk walking) in a sample of sedentary African American women. In addition, we will test the impact of varying types of counseling and social support on the adoption and maintenance of regular physical activity and help women improve their weight control. The core behavioral change program will be based on a comprehensive wellness oriented website offered by the National Black Women's Health Project (NBWHP). Comparisons will be made between the effects of the web-based program with only minimal face to face contacts, primarily for enrollment, data collection, and participant retention, the web-based program with the addition of telephone counseling and support, and the web-based program with face to face group counseling and support.

Hypotheses. Hypothesis 1. Participation in the intervention will result in increased physical activity levels, regardless of the level of social support.

Hypothesis 2. The intervention arm involving the lowest level of social support will be marginally effective for increasing physical activity levels, and additional social support will result in significantly improved physical activity levels when compared with the lowest level of social support.

The specific intervention questions are:

  1. How well do the interventions address the program objectives ((quality of implementation), to be determined through protocol review for operationalization of theoretical constructs)?
  2. Was the program implemented as planned ((fidelity to protocol and dose of intervention), to be determined from implementation process variables, including characteristics of women recruited, fidelity to protocols for contact with participants, and quality of counseling given, where applicable)?
  3. Did the program (separately for each format tested) have a significant effect on potential mediators of behavior change (influence on presumed intermediate outcomes)? For the purpose of this proposal, a mediator is defined as any barrier to or facilitator of physical activity participation (e.g., time, self efficacy, social support, access, perceived norms) as implied in the 12 behavioral objectives that have been specified.
  4. What is the optimum type of counseling and support to enhance the on-line activities in order to produce significant behavior change (importance of various program components)?
  5. Did the program (separately for each format tested) have a significant effect on the primary study outcomes (influence on primary behavioral outcome, e.g., physical activity by self-report of activity levels or pedometer counts)?
  6. Do changes in mediators explain changes in the primary outcomes (multivariate models to understand if presumed process of behavioral change was observed in practice)?
  7. Does the internet only program appear to result in increased physical activity participation when compared to extant data on trends among Black women in the U.S. population (what is accomplished with very minimal intervention and how does it compare with a more extensive program)?

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • African American Women
  • 18 years of age and older
  • Have a working telephone
  • Have reliable internet service

排除标准

  • Physical limitations and/or disabilities that would preclude a walking program
  • Report currently meeting the minimum physical activity guidelines, as they relate to health and/or weight loss

结局指标

主要结局

Physical activity level

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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Walking For Wellness Program Evaluation | 临床试验