Treatment of Obesity Targeting Appetite and Cue Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- binge eating as measured by the Eating Disorder Examination
研究概览
简要总结
The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.
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. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare ROC, BWL, ROC+BWL combined and an active comparator (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
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 between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and
- •Participants will provide written informed consent for study participation.
- •Participants will possess English language skills at the 5th grade reading level.
- •Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.
- •Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
- •Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months).
- •Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating.
- •Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
- •Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
- •Participants cannot have a history of bariatric surgery
- •Participants cannot currently be enrolled in an organized weight control program.
排除标准
- 未提供
研究组 & 干预措施
Regulation of Cues (ROC)
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.
干预措施: Regulation of Cues (ROC) (Behavioral)
Behavioral Weight Loss (BWL)
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
干预措施: Behavioral Weight Loss (BWL) (Behavioral)
BWL+ ROC
BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.
干预措施: BWL + ROC (Behavioral)
Nutrition Education, Stress Management Social Support
Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
干预措施: Nutrition Education, Stress Management and Social Support (Behavioral)
结局指标
主要结局
binge eating as measured by the Eating Disorder Examination
时间窗: Change from baseline at an average of 12 months and 24 months
body mass index as measured by height and weight
时间窗: Time Frame: Change from baseline at an average of 12 months and 24 months
次要结局
未报告次要终点
研究者
Kerri Boutelle
Professor
University of California, San Diego