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CHARGE: Controlling Hunger and ReGulating Eating (CHARGE)

Primary Purpose

Binge-Eating Disorder, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulation of Cues (ROC)
Cognitive Behavior Therapy (CBT)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Overweight, Obesity, Binge Eating, Overeating, Body Mass Index, Weight, Treatment, Intervention, Behavioral Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regulation of Cues (ROC)

Cognitive Behavior Therapy (CBT)

Arm Description

The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.

CBT provides coping skills, self-monitoring, and goal setting.

Outcomes

Primary Outcome Measures

Attendance
The number of treatment visits attended
Acceptability
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)
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)
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)
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
Energy intake
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days

Secondary Outcome Measures

Satiety Responsiveness
Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Food Responsiveness
Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
Reward-Based Eating
Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)

Full Information

First Posted
September 18, 2018
Last Updated
May 10, 2023
Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03678766
Brief Title
CHARGE: Controlling Hunger and ReGulating Eating
Acronym
CHARGE
Official Title
Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Overweight, Obesity
Keywords
Overweight, Obesity, Binge Eating, Overeating, Body Mass Index, Weight, Treatment, Intervention, Behavioral Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regulation of Cues (ROC)
Arm Type
Experimental
Arm Description
The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.
Arm Title
Cognitive Behavior Therapy (CBT)
Arm Type
Experimental
Arm Description
CBT provides coping skills, self-monitoring, and goal setting.
Intervention Type
Behavioral
Intervention Name(s)
Regulation of Cues (ROC)
Other Intervention Name(s)
ROC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance
Description
The number of treatment visits attended
Time Frame
Post-Treatment (5 months following baseline)
Title
Acceptability
Description
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)
Title
Binge Eating as measured by the Eating Disorder Examination (EDE)
Description
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
Title
Binge Eating as measured by the Binge Eating Scale (BES)
Description
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
Title
Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q)
Description
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
Title
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
Title
Energy intake
Description
Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
Time Frame
Changes from baseline at an average of 20 weeks and 44 weeks
Secondary Outcome Measure Information:
Title
Satiety Responsiveness
Description
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
Title
Food Responsiveness
Description
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
Title
Reward-Based Eating
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, Ph.D
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Healthy Eating and Activity Research (CHEAR)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22122291
Citation
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.
Results Reference
background
PubMed Identifier
24459240
Citation
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.
Results Reference
background

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CHARGE: Controlling Hunger and ReGulating Eating

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