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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
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.
Participants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of "forbidden" foods that are typically consumed during a binge.
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States
Attendance
The number of treatment visits attended
Time frame: Post-Treatment (5 months following baseline)
Acceptability
Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
Time frame: Post-Treatment (5 months following baseline)
Binge Eating as measured by the Eating Disorder Examination (EDE)
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.
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Binge Eating as measured by the Binge Eating Scale (BES)
Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
Time frame: 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)
Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Body Mass Index (BMI) as measured by weight and height
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Energy intake
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
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Time frame: Changes from baseline at an average of 20 weeks and 44 weeks
Satiety Responsiveness
Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Food Responsiveness
Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Reward-Based Eating
Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)
Time frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks