Targeting Food Cue Responsiveness for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index
研究概览
简要总结
The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.
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 Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; 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 BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).
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
- •high Food Responsiveness
- •BMI between 25kg/m^2 and 45kg/m^2
- •able to read English at a 5th grade reading level
- •willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
- •able to provide data through questionnaires
- •has a smart phone through which they can complete Ecological Momentary Assessments
排除标准
- •major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
- •bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)
- •medical or psychological problems that could make adherence with the study protocol difficult or dangerous
- •pregnant, lactating, or planning to become pregnant in the next 18 months
- •participating in other weight control programs and/or taking medication for weight loss
- •previous bariatric surgery
- •moving out of the San Diego area for the duration of their study enrollment (18 months)
研究组 & 干预措施
Regulation of Cues Enhanced Treatment
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.
干预措施: Regulation of Cues Enhanced (Behavioral)
Behavioral Weight Loss
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.
干预措施: Behavioral Weight Loss (Behavioral)
Nutrition, Stress Management, and 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
Change in Body Mass Index
时间窗: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Body Mass Index as measured by height and weight
次要结局
- Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ(Change from baseline at an average of 6 months, 12 months, and 18 months)
- Change in Eating Cognitions As Measured by the FCQ-T-reduced(Change from baseline at an average of 6 months, 12 months, and 18 months)
- Change in Food Responsiveness As Measured by the FR Scale of the AEBQ(Change from baseline at an average of 6 months, 12 months, and 18 months)
- Change in Restriction As Measured by the TFEQ(Change from baseline at an average of 6 months, 12 months, and 18 months)
- Change in Inhibition As Measured by the Stop Signal Task(Change from baseline at an average of 6 months, 12 months, and 18 months)
- Change in Caloric Intake As Measured by the DHQ III(Change from baseline at an average of 6 months, 12 months, and 18 months)
研究者
Kerri Boutelle
Kerri Boutelle, Ph.D., Professor, Herbert Wertheim School of Public Health and Longevity Science and School of Medicine Departments of Pediatrics and Psychiatry
University of California, San Diego