Comparison of Two Approaches to Weight Loss Follow-Up Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Obesity
研究概览
简要总结
This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet.
We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.
详细描述
***PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study***
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 30 and 40
- •Live and work within 1 hour of the study site
- •Stable psychological status
排除标准
- •History of heart disease, heart attack, or stroke
- •Blood pressure >140/90 mmHg
- •Abnormal cholesterol levels
- •Significant psychiatric illness
- •Any medication that affects weight or metabolic rate
- •Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
- •Currently using antidepressants, steroids, tobacco, or illegal drugs
- •Pregnant, breastfeeding, or planning pregnancy
- •10 lb change in weight within 6 months of study entry
- •History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
- •History of protein wasting diseases or gout
- •Severe arthritis
- •Osteoporosis
- •Certain types of hormone replacement therapy
- •Currently following a vegetarian diet
结局指标
主要结局
Obesity
次要结局
未报告次要终点