CHARGE: Controlling Hunger and ReGulating Eating

Obesity Clinical Trial

— CHARGE  

Official title:

Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678766
• Other study ID #: 181015
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego Veterans Healthcare System, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	The number of treatment visits attended	Post-Treatment (5 months following baseline)
Primary	Acceptability	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)
Primary	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.	Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Primary	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.	Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Primary	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.	Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Primary	Body Mass Index (BMI) as measured by weight and height		Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks
Primary	Energy intake	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	Satiety Responsiveness	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
Secondary	Food Responsiveness	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
Secondary	Reward-Based Eating	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