NCT01730196已完成不适用
Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 604
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-described African American
- •BMI ≥25kg/m2
- •Planning to remain within the community for 1 year
- •Non-diabetic
排除标准
- •Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
- •Active tuberculosis
- •Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
- •Stroke within the past 6 months
- •Cirrhosis of the liver
- •Currently pregnant or planning pregnancy within the study period
- •Gastric weight-loss surgery
- •Weight loss > 10% in past three months for any reason other than childbirth
- •Anti-diabetic medications
- •Prescription weight- loss medications
- •Anti-neoplastic agents
- •Anti-psychotic agents that have gluco-corticoid effect
- •Oral corticosteroid use >6 weeks
- •Unwilling or unable to give informed consent
- •Unable to communicate with the church team or research group
- •Participation in another research study that would interfere with FBAS
结局指标
主要结局
Weight change
时间窗: 12-weeks post intervention
次要结局
- Fasting plasma glucose(12 week post intervention)
- quality of life measures(12 week post-intervention)
- hemoglobin A1C(12 week intervention)
- physical activity level(12 week post-intervention)
- cost-effectiveness(12 week post-intervetnion)
研究者
Richard Sattin
Professor and Research Director, Department of Emergency Medicine
Augusta University
研究点 (2)
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