Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.
详细描述
None needed
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
- •The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)
排除标准
- •Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
- •Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
- •Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program
结局指标
主要结局
Weight loss
时间窗: Six months
Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.
次要结局
- Functional capacity(6 months)