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临床试验/NCT00669630
NCT00669630已完成不适用

The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2008年9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
392
试验地点
2
主要终点
Diet History Questionnaire; 7 - Day Physical Activity Recall

研究概览

简要总结

This study will train Lay Health Promoters (LHPs) from African-American churches to administer healthy living lessons and activities to their congregations in order to improve overall health and address cardiovascular disease. The primary hypothesis is that LHP training combined with a well supported maintenance strategy will be more effective than LHP training alone in reducing risk factors for cardiovascular disease.

详细描述

The GoodNEWS Trial is an 18-month effectiveness trial with an 18-month extended maintenance study, among 20 African-American and low-income congregations participating in the GoodNEWS faith-based lay health promotion program. After training, congregations will be randomized to either GoodNEWS with a health maintenance intervention (GoodNEWS-I) or GoodNEWS program alone (GoodNEWS-PA). The maintenance intervention combines elements of the medical care model and features of community-based support. Primary data collection will occur at baseline, 18, and 36 months with the two primary outcomes being levels of physical activity as measured by 7- Day Physical Activity Recall (PAR) and dietary change as measured by the Diet History Questionnaire (DHQ). The primary hypothesis is that the maintenance group will significantly increase physical activity and healthy eating behavior compared to the program only group. We also hypothesize that lipoprotein and glucose levels, and blood pressure will be significantly improved over baseline in the GoodNEWS-I group and that these changes will be significantly greater than in the GoodNEWS-PA group. At the end of the trial, both groups will continue in an 18-month extended maintenance study.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Member of selected church congregations in the predominantly African-American geographical area of Dallas, Texas, known as South Dallas or the Southern Sector.
  • Between the ages of 18 -70 years

排除标准

  • Anyone under the age of 18
  • Anyone who is not an active member of one of the participating churches

结局指标

主要结局

Diet History Questionnaire; 7 - Day Physical Activity Recall

时间窗: Baseline, 18 months, and 36 months

次要结局

  • Blood pressure; Total cholesterol, HDL, LDL, Triglycerides; Glucose level; Hemoglobin A1C (Diabetics only)(Baseline, 18-months, and 36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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