Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study.
Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study.
复制标题
非裔美国教会糖尿病预防计划的整群随机对照试验设计：健康的身体和灵魂研究。
DOI：
10.1016/j.cct.2013.01.002
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发表时间：
2013
影响因子：
2.2
通讯作者：
Narayan,KMVenkat
中科院分区：
文献类型：
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作者：
Williams,LovoriaB;Sattin,RichardW;Dias,James;Garvin,JaneT;Marion,Lucy;Joshua,Thomas;Kriska,Andrea;Kramer,MKaye;Echouffo-Tcheugui,JustinB;Freeman,Arin;Narayan,KMVenkat
来自不同社区环境的证据表明，群体生活方式平衡（GLB）计划和糖尿病预防计划（DPP）干预的其他调整对降低糖尿病风险有效。大多数DPP数据来自糖尿病前期白人的研究，只有很少的证据表明DPP对社区环境中的非洲裔美国人（AAs）的影响。本文描述了一项基于信仰的GLB项目适应性的单盲、集群随机试验的设计、方法、基线特征和成本效益措施，Fit Body and Soul （FBAS）。主要目的是在20个AA教会中测试FBAS的有效性和成本效用。随机化发生在教会水平，604名AA超重/肥胖（BMI≥25kg/m2）空腹血糖范围从正常到糖尿病前期的成年人接受了FBAS或健康教育比较计划。FBAS是一种基于群体的多层次干预，由训练有素的教会健康顾问（教会内部的健康专业人员）提供，目标是通过增加体育活动、健康饮食和行为改变来实现体重减轻≥7%。主要结果是干预后12周的体重变化。次要结局包括糖化血红蛋白、空腹血糖、腰围、血压、体力活动水平、生活质量指标和成本效益。依靠教会内部的卫生专业人员进行项目实施和成本分析是这项试验的独特之处。该设计为基于信仰的dpp提供了一个模型，并有望实现项目的可持续性和广泛传播。
Evidence from varied community settings has shown that the Group Lifestyle Balance (GLB) Program and other adaptations of the Diabetes Prevention Program (DPP) intervention are effective in lowering diabetes risk. Most DPP data originated from studies of pre-diabetic whites, with only sparse evidence of the effect of DPP in African Americans (AAs) in community settings. This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster-randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul (FBAS). The major aims are to test efficacy and cost utility of FBAS in twenty AA churches. Randomization occurred at the church level and 604 AA overweight/obese (BMI≥25kg/m2) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program. FBAS is a group-based, multi-level intervention delivered by trained church health advisors (health professionals from within the church), with the goal of ≥7% weight loss, achieved through increasing physical activity, healthy eating and behavior modification. The primary outcome is weight change at 12weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination.