Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Weight Loss
研究概览
简要总结
A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.
详细描述
Objective
To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction.
Design, Setting, and Participants: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.
Intervention: A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence.
Main Outcome Measures: One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report. Outcome measures included body weight, total cholesterol, LDL-C, HDL-C, triglycerides, hsCRP, insulin, glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 27-42;
- •At least one metabolic cardiac risk factor
排除标准
- •Age under 18 years;
- •Insulin therapy;
- •Unstable chronic illness;
- •Unwilling to follow dietary advice
研究组 & 干预措施
Atkins Diet
Atkins Diet (dietary counseling)
干预措施: Atkins Diet (Behavioral)
Zone Diet
Zone Diet (dietary counseling)
干预措施: Zone Diet (Behavioral)
Weight Watchers Diet
Weight Watchers Diet (dietary counseling)
干预措施: Weight Watchers Diet (Behavioral)
Ornish Diet
Ornish Diet (dietary counseling)
干预措施: Ornish Diet (Behavioral)
结局指标
主要结局
Weight Loss
时间窗: 1 year
Change from baseline body weight at 1 year, measured in kilograms
次要结局
- Total Cholesterol(1 year)
- LDL Cholesterol(1 year)
- HDL Cholesterol(1 year)
- Triglycerides(1 year)
- Glucose(1 year)
- Insulin(1 year)
- C-reactive Protein(1 year)