- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678766
CHARGE: Controlling Hunger and ReGulating Eating (CHARGE)
May 10, 2023 updated by: Kerri Boutelle, University of California, San Diego
Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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
Enrollment (Actual)
129
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regulation of Cues (ROC)
The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.
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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 Names:
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Experimental: Cognitive Behavior Therapy (CBT)
CBT provides coping skills, self-monitoring, and goal setting.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance
Time Frame: Post-Treatment (5 months following baseline)
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The number of treatment visits attended
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Post-Treatment (5 months following baseline)
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Acceptability
Time Frame: Post-Treatment (5 months following baseline)
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Average likert ratings to questions, such as "How much did you enjoy the treatment?"
and "How helpful did you find the treatment?"
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Post-Treatment (5 months following baseline)
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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
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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.
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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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
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Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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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
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Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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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
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Energy intake
Time Frame: Changes from baseline at an average of 20 weeks and 44 weeks
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Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
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Changes from baseline at an average of 20 weeks and 44 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety Responsiveness
Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Food Responsiveness
Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Reward-Based Eating
Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)
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Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kerri Boutelle, Ph.D, UCSD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
- Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2018
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
September 18, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 10, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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