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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

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:

  1. All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
  2. Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
  3. Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
  4. Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
  5. Participants will be willing to maintain contact with the investigators for 11 months.
  6. 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.
  7. 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.
  8. Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
  9. Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
  10. Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
  11. 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.
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 Names:
  • ROC
Experimental: Cognitive Behavior Therapy (CBT)
CBT provides coping skills, self-monitoring, and goal setting.
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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: Post-Treatment (5 months following baseline)
The number of treatment visits attended
Post-Treatment (5 months following baseline)
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?"
Post-Treatment (5 months following baseline)
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.
Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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.
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)
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.
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
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
Changes from baseline at an average of 20 weeks and 44 weeks

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
Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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)
Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
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)
Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

United States Department of Defense
San Diego Veterans Healthcare System

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

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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