Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Attendance
概览
简要总结
The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).
详细描述
The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators will recruit and randomize 120 male and female Veterans with BED and subclinical BED with comorbid overweight/obesity, provide 5 months of treatment and follow participants for 6-months post-treatment. Participants will complete assessments at baseline, mid-treatment (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the first to contribute to a body of literature developing treatments for BED and overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.
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 (Outcomes Assessor)
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
- 否
入选标准
- •All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥
- •Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
- •Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
- •Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
- •Participants will be willing to maintain contact with the investigators for 11 months.
- •Participants will be free of serious or unstable medical (current symptoms of angina, stroke, heart disease or other serious medical condition that would make physical activity unsafe or impossible at a moderate level) or psychiatric illness (i.e., active suicidal ideation, history of suicide attempt within 1 year, current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation.
- •Participants will be free from conditions in which exercise or weight loss will be detrimental to the participant's health (e.g., pregnancy); pharmacotherapy for obesity or binge eating disorder (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 11 months.
- •Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
- •Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
- •Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
排除标准
- 未提供
结局指标
主要结局
Attendance
时间窗: Post-Treatment (5 months following baseline)
The number of treatment visits attended
Body Mass Index (BMI) as measured by weight and height
时间窗: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q)
时间窗: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
Acceptability
时间窗: Post-Treatment (5 months following baseline)
Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
Binge Eating as measured by the Eating Disorder Examination (EDE)
时间窗: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Diagnosis of Binge Eating Disorder (BED) and subclinical BED, number of OBEs (large amount of food and loss of control), objective overeating episodes (large amount of food without loss of control), and SBEs (lack of large amount of food with loss of control) determined by responses to the EDE.
Binge Eating as measured by the Binge Eating Scale (BES)
时间窗: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
Energy intake
时间窗: Changes from baseline at an average of 20 weeks and 44 weeks
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
次要结局
- Satiety Responsiveness(Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks)
- Food Responsiveness(Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks)
- Reward-Based Eating(Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks)
研究者
Kerri Boutelle
Professor
University of California, San Diego