跳至主要内容
临床试验/NCT00991731
NCT00991731已完成不适用

A Faith-Based Intervention to Increase Physical Activity Among Blacks

Melicia Whitt-Glover1 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2009年7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
发起方
入组人数
496
试验地点
1
主要终点
Comparing the efficacy of faith-based vs non-faith-based to a control condition in increasing daily physical activity measured as steps/day.

研究概览

简要总结

The purpose of this research study is to evaluate three different approaches for increasing physical activity in African American women who are not currently doing enough physical activity. One approach will teach people about physical activity, in groups, using general principles (general physical activity program). The second approach will teach people about physical activity, in groups, using principles from the bible (faith-based physical activity program). The third approach will teach people about physical activity by giving them written materials created at the National Institutes of Health (control group). Control groups are used in research studies to see if the program being studied really does have an effect on physical activity. At the end of the study, people in the control group will also participate in either the general physical activity program or the faith-based physical activity program.

详细描述

The intervention will be conducted in 24 churches. Participating churches will be recruited from the list of churches that participated in the Health Ministry Institute, a program including ~40 minority-serving churches in Forsyth County conducted by Dr. Whitt-Glover 2 years ago. We will enroll churches from the list of participating HMI churches over a two-year period until 24 churches have been recruited for randomization. If we exhaust the list of HMI before we have 24 churches enrolled in the study, we will place advertisements in local newspapers and send out directed mailings to the ~210 minority-serving churches in Forsyth County, NC explaining the study and inviting them to send a representative to a study information session to learn more.

Eligible participants will include 480 African American women > 18 years of age who report that they are not currently meeting the guidelines for regular moderate or vigorous physical activity. Participants should have no physical limitations or disabilities that would limit physical activity participation. In addition, participants should have no contraindications for increasing daily physical activity, such as recent myocardial infarction or congestive heart failure, and should be willing to participate in a two-year study.

Participants in the active intervention will participate in 24 group sessions. Sessions 1 - 16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur monthly. Sessions will be scheduled to last for 90 minutes each. This will include a 30-minute physical activity session (led by a trained exercise leader) and 60 minutes of group discussion (led by a Community Health Worker trained in group facilitation, familiarity with theology and health ministry education, and experience implementing group-based activities in faith settings). Group discussion content will be standardized to ensure consistent delivery.

Thirty-Minute Physical Activity Session. At the beginning of each weekly meeting and immediately prior to the group discussion, participants will engage in a standard 30-minute physical activity session led by a trained exercise leader. The 30-minute physical activity session will include warm-up, an activity period, and cool down. Inclusion of an exercise period during the weekly sessions proved to be a motivator for on-time arrival to weekly sessions during the pilot study, as well as an opportunity for participants to learn methods for proper warm-up and cool-down prior to and following physical activity, as well as time to rehearse using physical activity incentives (e.g., exercise tapes, hand weights), and to understand the body's physiological reactions to moderate-intensity physical activity (i.e., many participants in the pilot study were not exactly sure what moderate-intensity physical activity felt like (e.g., how hard should they be breathing, what should heart rate be?) and may not have engaged in the appropriate intensity-level for physical activity outside of class without opportunities to rehearse activity in class).

Group-Based Intervention Sessions. The group discussion sessions will be led by a Community Health Worker and the format will be similar for each group and will include five segments:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •African American women > 18 years of age who report that they are not currently meeting the guidelines for regular moderate or vigorous physical activity.
  • •No physical limitations or disabilities that would limit physical activity participation.
  • •No contraindications for increasing daily physical activity, such as recent myocardial infarction or congestive heart failure, and should be willing to participate in a two-year study.

排除标准

  • •Individuals <18 years of age will be ineligible for participation.
  • •Those with walking aids (e.g., walkers, canes).
  • •Those who may need additional medical clearance (e.g., severe obesity) will be asked to obtain clearance prior to formal enrollment into the study.

研究组 & 干预措施

Faith-based

Active Comparator

Faith-based interventions incorporate tenets of the faith-based organization (e.g., religious beliefs, scriptural references) and involve the faith-based organization in the planning of the intervention from beginning to end

干预措施: Faith-based (Behavioral)

Non-faith-based

Active Comparator

A curriculum designed for delivery without biblical references. In the traditional teachings of how to increase physical activity.

干预措施: Non-faith-based (Behavioral)

Control

No Intervention

This group will receive a printed pamphlet "Energize Yourself! Stay Physically Active", published by the National Heart Lung and Blood Institute, that encourages participation in at least 30 minutes of daily physical activity all at once or in bouts lasting 10 minutes at a time.

结局指标

主要结局

Comparing the efficacy of faith-based vs non-faith-based to a control condition in increasing daily physical activity measured as steps/day.

时间窗: baseline, 10 months, and 22 months

次要结局

未报告次要终点

研究者

发起方
Melicia Whitt-Glover
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melicia Whitt-Glover

President & CEO

Gramercy Research Group

研究点 (1)

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