Diet & Activity Community Trial: High-Risk Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 2
- 主要终点
- Change in C-Reactive Protein (CRP) levels from baseline to post intervention
研究概览
简要总结
South Carolina has many gaps in health status of our citizens. Some of the biggest gaps are higher cancer rates among African Americans. The purpose of this study is to find people who have increased inflammation and study how well a community-based dietary and physical activity program works at reducing the risk of African Americans developing inflammation-related diseases.
详细描述
A diet and physical activity intervention was developed to provide knowledge and skills to facilitate health behavior change in African-American Baptist Church members in South Carolina and promote healthy lifestyles to reduce colon cancer disparities. The intervention entitled, "H.E.A.L.S. (Healthy Eating and Active Living in the Spirit)" was used to train church education teams to deliver church and community educational activities promoting a diet rich in fruits and vegetables and an active lifestyle. The training focused leadership and empowerment skills to enable church lay leaders to become Church Education Teams (CETs) . The educational activities made it easier for church and community members to eat more fruits and vegetables, reduce fat intake, increase physical activity, and increase dietary intake of anti-inflammatory foods associated with colon cancer risk.
This 12 week healthy eating and physical activity program is tailored to meet a church's needs and goals by:
- providing cooking classes, recipes,
- tips for increasing the level of physical activity in their daily routine
- assistance tracking basic measurements like
- Weight
- Blood pressure,
- Inflammation levels
Education Goals:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American
排除标准
- •History of Cancer
- •History of Ulcerative colitis
- •Chrome Disease
结局指标
主要结局
Change in C-Reactive Protein (CRP) levels from baseline to post intervention
时间窗: Baseline, Post Intervention (90) days) and 12 months beyond baseline
Data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.
次要结局
- Change in waist-to-hip ratio(WHR) values from baseline to either 90 days or 12 months or both.(Baseline, Post intervention (90 days) and 12 months beyond baseline.)
- Change in Interleukin 6 (IL6) values from baseline to either 90 days or 12 months or both.(Baseline, Post intervention (90 days) and 12 months beyond baseline.)
- Change in body mass index (BMI) values from baseline to either 90 days or 12 months or both.(Baseline, Post intervention (90 days) and 12 months beyond baseline.)
- Change in mcp-1 values from baseline to either 90 days or 12 months or both.(Baseline, Post intervention (90 days) and 12 months beyond baseline.)
- Change in body fat mass (BFM) values from baseline to either 90 days or 12 months or both.(Baseline, Post intervention (90 days) and 12 months beyond baseline.)
研究者
James hebert
James R. Hebert, MSPH, ScD, Director
University of South Carolina