KU Alternate Meal Energy Level Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.
详细描述
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
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 (Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-65 years.
- •Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI >35 may require more aggressive weight management strategies.
- •Clearance for participation from their PCP.
排除标准
- •Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
- •Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34].
- •Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire
- •Unwilling to be randomized to one of two diet strategies for weight loss.
- •Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
- •Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
- •Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater [35]. This score indicates the need for counseling outside the scope of this study.
- •Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
- •Medications known to significantly influence weight.
- •Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
- •Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
- •If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.
结局指标
主要结局
Body composition
时间窗: Change from baseline to 24 weeks
Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks
Weight (lbs, % change from baseline)
时间窗: Change from baseline to 24 weeks
Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)
次要结局
- Program adherence(weekly through study completion (24 weeks))
- Nutrition-related quality of life(baseline, week 12, week 24)
- Dietary restraint(baseline, week 12, week 24)
研究者
Debra K. Sullivan, PhD, RD
Professor
University of Kansas Medical Center