Preference and Vegetarian Diet in Weight Loss Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- weight change at 18 months
研究概览
简要总结
We propose to add a treatment preference component to a larger study testing standard behavioral treatment (SBT) for weight loss without specific food group restriction vs standard behavioral treatment with gradual elimination of meat, poultry, and fish [a lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be randomized to either SBT or SBT+LOV without regard to their preference.
详细描述
Both groups will receive the behavioral treatment program (32 sessions over 12 months) that has been used successfully in numerous behavioral weight loss studies conducted by Dr. Wing.42-44 The Treatment Preference-Yes and -No Groups will meet on separate evenings to avoid contamination across the conditions but will be led by the same multidisciplinary team (behavioral scientists, nutritionist, exercise physiologist). A brief description of elements common to both groups follows:
Group Sessions: Groups will meet for 45-60 minutes weekly for Months 1-6, bi-weekly for Months 7-9, and monthly for Months 10-12. Participants will be weighed, receive nutritional and behavioral counseling, turn in the weekly diaries, and receive homework assignments at the sessions.
Dietary Restrictions: Calorie Goal. Participants will receive an individualized calorie goal calculated from baseline body weight (1200 calories < 200 lbs; 1500 calories for > 200 lbs), used successfully in previous studies.42 Fat Goal. Fat gram goals will approximate 25% of calories.
Physical Activity and Exercise: Participants will gradually increase their exercise, primarily walking, until they reach a minimum goal of 150 minutes per week (a caloric expenditure of 1000 calories/wk).
Behavioral Strategies to Use in Changing Eating and Exercise Habits: The central features follow:
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) be 18 to 55 years of age; (2) have a BMI of at least 27 but not greater than 43; (3) be willing to be randomized to one of the two preference conditions (Yes/No) and one of the two treatment conditions (SBT or SBT+LOV); and (4) have successfully completed a 5-day diary
排除标准
- •(1) presence of a current serious illness or unstable condition (e.g., acute myocardial infarction or diabetes) for which physician supervision of diet and exercise prescription is needed; (2) presence of cardiovascular or orthopedic condition that would require physician clearance prior to participation; (3) limitations precluding ability to exercise; (4) pregnancy or intention to become pregnant in the next 18 months; (5) current treatment for a psychological disorder; (6) reported alcohol intake >4 drinks/day; (7) current or recent (past 6 months) participation in a weight loss treatment program or use of weight loss medication; (8) reporting no regular intake of meat, fish, and fowl; or presence of a serious binge eating problem
研究组 & 干预措施
Standard Behavioral Treatment
Goal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change.
Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors.
Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement.
干预措施: Standard Behavioral Treatment (Behavioral)
SBT+LOV Group
In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). .
干预措施: Standard Behavioral Treatment (Behavioral)
SBT+LOV Group
In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). .
干预措施: SBT+LOV (Behavioral)
结局指标
主要结局
weight change at 18 months
时间窗: 18 months
次要结局
未报告次要终点
研究者
Lora Burke
Professor
University of Pittsburgh