Changing Lifestyles for Better Health: A Model Program for Community Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style intervention (ILI) program that has been developed and implemented at the FHCHC to prevent the development of diabetes.
详细描述
This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community expertise of the FHCHC Diabetes Team, and the high-need patient population of FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for this study, the following criteria must be met:
- •Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
- •Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
- •Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
- •Subjects must have no medical contraindications to exercise or dieting.
排除标准
- •Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
- •Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
- •Women who are pregnant or planning to become pregnant will not be enrolled in this study.
- •Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
- •Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.
结局指标
主要结局
Change in Weight
时间窗: Baseline and 12 Months
The change is weight is reported from baseline to 12 months.
Change in Waist Circumference
时间窗: Baseline and 12 Months
Change in waist circumference was measured from baseline to 12 months
Change in BMI
时间窗: Baseline and 12 Months
The change in BMI is reported from baseline to 12 months.
Change in Percent Body Fat
时间窗: Baseline and 12 Months
Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used.
Change in Blood Pressure
时间窗: Baseline and 12 Months
Change in blood pressure was measured from baseline to 12 months
次要结局
- Physical Activity Levels (Self-reported)(12 months)