CHARGE: Controlling Hunger and ReGulating Eating (CHARGE)
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ClinicalTrials.gov Identifier: NCT03678766 |
Recruitment Status :
Active, not recruiting
First Posted : September 20, 2018
Last Update Posted : April 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Binge-Eating Disorder Overweight Obesity | Behavioral: Regulation of Cues (ROC) Behavioral: Cognitive Behavior Therapy (CBT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 131 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight |
Actual Study Start Date : | September 30, 2018 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |
Arm | Intervention/treatment |
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Experimental: Regulation of Cues (ROC)
The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.
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Behavioral: Regulation of Cues (ROC)
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.
Other Name: ROC |
Experimental: Cognitive Behavior Therapy (CBT)
CBT provides coping skills, self-monitoring, and goal setting.
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Behavioral: Cognitive Behavior Therapy (CBT)
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.
Other Name: CBT |
- Attendance [ Time Frame: Post-Treatment (5 months following baseline) ]The number of treatment visits attended
- Acceptability [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q) [ Time Frame: 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.
- 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 [ Time Frame: 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
- Satiety Responsiveness [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
- Food Responsiveness [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
- Reward-Based Eating [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
- 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.
- Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678766
United States, California | |
UCSD Center for Healthy Eating and Activity Research (CHEAR) | |
La Jolla, California, United States, 92093 |
Principal Investigator: | Kerri Boutelle, Ph.D | UCSD |
Responsible Party: | Kerri Boutelle, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03678766 |
Other Study ID Numbers: |
181015 |
First Posted: | September 20, 2018 Key Record Dates |
Last Update Posted: | April 18, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Overweight Obesity Binge Eating Overeating Body Mass Index |
Weight Treatment Intervention Behavioral Treatment |
Overweight Bulimia Feeding and Eating Disorders Binge-Eating Disorder |
Body Weight Mental Disorders Hyperphagia Signs and Symptoms, Digestive |