PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Regulation of Cues (ROC); Behavioral Weight Loss (BWL); BWL + ROC; Nutrition Education, Stress Management and Social Support
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger,satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.; All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.; BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure sessions in the clinic.; Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.
Other intervention name(s): ROC; BWL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Overeating; Body Mass Index; Weight; Treatment; Cravings; Intervention; Behavioral Treatment