Using the Energy Gap to Prevent Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All ethnic groups and both genders
- •Age: Lower age limit: 19 years; Upper age limit: 45 years
- •Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
- •A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.
排除标准
- •History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)
- •Currently smoking or stopped smoking in the last 12 months
- •Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- •Use of oral steroids within the last 12 months
- •History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
- •Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
- •Infectious diseases: Self-reported HIV positivity or Active tuberculosis
- •Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss
- •Likely to move away in next 1.5 years
- •Inability to adhere to the program such as inability to increase walking
- •Currently pregnant, lactating or less than 6 months post-partum
- •Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)
- •Current depression by history or Beck Depression Inventory (BDI)
- •Currently being treated for psychological condition
研究组 & 干预措施
1
Increased amount of exercise to maintain weight loss.
干预措施: increased exercise (Behavioral)
2
Combination of Exercise and Diet to maintain weight loss
干预措施: Exercise and Diet (Behavioral)
3
Use diet alone to maintain weight loss.
干预措施: diet (Behavioral)
结局指标
主要结局
Change in Weight
时间窗: 18 Months
次要结局
未报告次要终点