Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Total weight loss
研究概览
简要总结
The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Type 2 diabetes
- •BMI 25-45 kg/m2
- •Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period
- •Able to comply with all required study procedures and schedule
- •Must live within the San Diego or Minneapolis area
排除标准
- •Pregnant, breastfeeding or planning to become pregnant in the next year
- •Serious medical condition or psychiatric illness
- •History of having an eating disorder, food allergy or food intolerance
- •Have food restrictions or requires a special diet
- •Objects to frozen, processed or prepackaged foods
- •Inability to be moderately physically active
- •Currently enrolled in a weight loss program or another diet intervention
- •Current use of weight loss medication or supplements
- •Planned surgical procedure that can impact the conduct of the study
- •Previous surgical procedures for weight reduction
- •Does not have own transportation
- •Have plans to relocate from area within 1 year
- •HbA1C >11%, fasting triglycerides >600 mg/dL, serum creatinine >1.4 mg/dL (women) or 1.5 mg/dL (men) -- to be screened at baseline visit
研究组 & 干预措施
Individualized Counseling
干预措施: Individualized Counseling (Other)
Higher Carbohydrate/Lower Fat Diet
干预措施: Higher Carbohydrate, Lower Fat Diet (Other)
Lower Carbohydrate/Higher Fat Diet
干预措施: Lower carbohydrate, Higher fat diet (Other)
结局指标
主要结局
Total weight loss
时间窗: 1 year
To test, in a randomized controlled trial, whether participation in a commercial weight loss program promotes greater weight loss and weight loss maintenance at one year in overweight or obese men and women with type 2 diabetes compared to usual care conditions.
次要结局
- Response to macronutrient composition(1 year)
- Biochemical/social outcomes(1 year)
研究者
Cheryl Rock
Principal Investigator
University of California, San Diego