NCT03678766

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

September 18, 2018

Last Update Submit

May 10, 2023

Conditions

Binge-Eating DisorderOverweightObesity

Keywords

OverweightObesityBinge EatingOvereatingBody Mass IndexWeightTreatmentInterventionBehavioral Treatment

Outcome Measures

Primary Outcomes (7)

  • Attendance

    The number of treatment visits attended

    Post-Treatment (5 months following baseline)

  • 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)

  • 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

  • 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

  • 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

  • Body Mass Index (BMI) as measured by weight and height

    Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks

  • 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 Outcomes (3)

  • Satiety Responsiveness

    Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks

  • Food Responsiveness

    Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks

  • Reward-Based Eating

    Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks

Study Arms (2)

Regulation of Cues (ROC)

EXPERIMENTAL

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

Behavioral: Regulation of Cues (ROC)

Cognitive Behavior Therapy (CBT)

EXPERIMENTAL

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

Behavioral: Cognitive Behavior Therapy (CBT)

Interventions

Regulation of Cues (ROC)BEHAVIORAL

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.

Also known as: ROC
Regulation of Cues (ROC)
Cognitive Behavior Therapy (CBT)BEHAVIORAL

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.

Also known as: CBT
Cognitive Behavior Therapy (CBT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

Related Publications (4)

  • 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.

    PMID: 22122291BACKGROUND

  • 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.

    PMID: 24459240BACKGROUND

  • Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Pasquale EK, Peterson CB. Regulation of Cues vs Cognitive Behavioral Therapy for Binge Eating and Weight Loss Among Veterans: A Feasibility and Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525064. doi: 10.1001/jamanetworkopen.2025.25064.

    PMID: 40758351DERIVED

  • Boutelle KN, Afari N, Obayashi S, Eichen DM, Strong DR, Peterson CB. Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity. Contemp Clin Trials. 2023 Jul;130:107234. doi: 10.1016/j.cct.2023.107234. Epub 2023 May 19.

    PMID: 37210072DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderOverweightObesityBulimiaHyperphagiaBody Weight

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kerri Boutelle, Ph.D

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 20, 2018

Study Start

September 30, 2018

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

US(1)