COR Protocol for the Treatment of Binge Eating in Chilean Adults (COR)

NCT07435974 | Recruiting

• 1 other identifier: Fondecyt Iniciacion 11230678
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn whether a brief online psychological program called COR can be delivered in a feasible and acceptable way for adults who experience recurrent binge eating. The main questions this study aims to answer are:

• Is the COR program acceptable to participants, in terms of satisfaction, adherence, and dropout rates?
• Is the COR program feasible to deliver online, including recruitment, retention, and completion of sessions and questionnaires?
• Do participants show preliminary changes over time in binge eating-related distress and emotional well-being? Participants in this study are adults who experience recurrent episodes of binge eating. They will take part in an individual online intervention that includes eight weekly sessions, a brief pre-session, and a follow-up session one month after the end of treatment. During the study, participants will:
• Attend weekly online sessions focused on understanding binge eating, emotions, and the relationship with food and the body
• Practice simple exercises to help manage emotional distress and food-related urges
• Complete short questionnaires before, during, and after the intervention to describe their experiences The information from this study will help researchers understand whether this type of intervention can be used in future, larger studies and in real-world clinical settings.

Conditions

Binge Eating Disorder; Binge Eating

Keywords

Binge eating; Binge Eating Disorder; Body compassion; Emotion regulation; Intuitive eating

Outcome Measures

Primary Outcomes (7)

• Proportion of Eligible Participants Who Initiate the COR Intervention

  Recruitment rate is defined as the proportion of eligible individuals who begin the COR intervention, calculated as the number of eligible participants who start the intervention divided by the number of eligible individuals who were successfully contacted and formally invited to participate during the recruitment period.

  At enrollment.

• Proportion of Participants Who Complete All Eight COR Intervention Sessions

  Retention during the intervention is defined as the proportion of participants who complete all eight scheduled COR intervention sessions.

  Up to 8 weeks.

• Proportion of Participants Who Attend the 1-Month Follow-Up Session After Completing the COR Intervention

  Retention at follow-up is defined as the proportion of participants who completed the eighth COR intervention session and subsequently attended the 1-month follow-up session.

  Up to 12 weeks.

• Proportion of Participants Who Discontinue the COR Intervention Before Completing All Eight Sessions

  Dropout rate is defined as the proportion of participants who discontinue the COR intervention before completing all eight scheduled sessions. When available, participants' self-reported reasons for discontinuation will be recorded descriptively.

  Up to 8 weeks.

• Proportion of Scheduled Assessment Instruments Completed by Participants

  Assessment completeness is defined as the proportion of scheduled assessment instruments completed by participants relative to the total number of instruments planned. This includes both formal assessment batteries administered at predefined study time points and weekly monitoring measures collected during the intervention period. This outcome evaluates the feasibility of data collection procedures.

  From baseline through 12 weeks.

• Acceptability of the COR Protocol Among Participants and Interventionists

  Acceptability of the COR protocol will be assessed using both participant- and interventionist-reported indicators. Participant acceptability will be assessed at post-treatment using the Client Satisfaction Questionnaire (CRES-4), which captures overall satisfaction with the intervention and perceived usefulness. Participant experiences regarding the intervention format, duration, contents, and strategies will be further explored through semi-structured qualitative interviews conducted after completion of the intervention. Interventionist acceptability will be assessed through semi-structured qualitative interviews focused on perceived adequacy, usability, and fit of the COR protocol within the clinical context.

  At completion of the eighth COR intervention session (session 8).

• Implementation Fidelity of the COR Protocol

  Implementation fidelity of the COR protocol will be assessed by evaluating whether the intervention is delivered as intended. This includes assessment of (a) adherence to the core contents, objectives, and strategies specified for each session, (b) quality of intervention delivery (e.g., structure, clarity, and consistency with the COR model), and (c) participant exposure to the intervention (dose received), operationalized through session attendance, session duration, and completion of between-session tasks. Fidelity indicators will be primarily collected using a therapist-completed adherence checklist administered after each session, complemented by attendance and session-duration records. Descriptive information regarding implementation challenges and adaptations will also be recorded to support monitoring and future refinement of the protocol.

  From the first COR intervention session (session 1) through completion of the eighth COR intervention session (session 8), assessed over 8 weeks.

Secondary Outcomes (5)

• Change in Binge-Eating Symptoms

  From baseline through 12 weeks.

• Change in General Psychological Distress (CORE-OM)

  From baseline through 12 weeks.

• Change in Difficulties in Emotion Regulation (DERS)

  From baseline through 12 weeks.

• Change in Body Compassion

  From baseline through 12 weeks.

• Change in Emotional Eating

  From baseline through 12 weeks.

Study Arms (1)

COR Protocol

EXPERIMENTAL

Behavioral: COR Protocol (Body Compassion - Emotional Regulation - Conscious Reconnection with Food)

Interventions

COR Protocol (Body Compassion - Emotional Regulation - Conscious Reconnection with Food) BEHAVIORAL

The COR protocol (Body Compassion-Emotional Regulation-Conscious Reconnection with Food) is a brief, manualized psychological intervention designed to address recurrent binge eating in adults. The intervention is delivered individually in an online format and consists of eight weekly sessions, preceded by an initial pre-session and followed by a one-month follow-up session. COR integrates elements from cognitive-behavioral therapy for eating disorders, dialectical behavior therapy skills, and principles of intuitive eating, within a non-weight-centered and compassion-focused framework. The intervention targets key psychological processes involved in binge eating, including emotional regulation, responses to food-related urges and cravings, and the development of a more compassionate relationship with the body and eating. Sessions include psychoeducation, functional analysis of binge episodes, experiential exercises, brief regulation practices, and reflective between-session activities.

COR Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Overweight or obesity, based on self-report.
• At least three binge-eating episodes in the past 30 days, associated with psychological distress.
• The presence of chronic medical conditions commonly associated with overweight or obesity (e.g., hypothyroidism, hyperthyroidism, dyslipidemia, hypertension, type 2 diabetes mellitus, or polycystic ovary syndrome) is permitted, provided that such conditions are medically stable.
• If present, chronic medical conditions must be medically stable, defined as:
• stable medical treatment for at least 12 weeks,
• no recent changes in medication,
• no acute clinical decompensation or recent major cardiovascular events,
• at least one related medical follow-up visit in the past 12 months.
• If present, psychopharmacological treatment must be stable, defined as no changes in medication type or dosage during the 12 weeks prior to enrollment.
• Daily access to the internet and to a computer or smartphone that allows participation in online sessions and assessments.

You may not qualify if:

• Current compensatory behaviors associated with binge eating, such as self-induced vomiting and/or regular use of laxatives, within the past 60 days.
• Pregnancy or breastfeeding at the time of the initial assessment.
• History of bariatric surgery.
• Active suicidal ideation
• Current symptoms consistent with severe mental disorders, such as psychotic disorders, bipolar disorder, complex post-traumatic stress disorder, or severe personality disorders, when associated with marked functional impairment or the need for specialized or higher-intensity clinical care.
• Current substance use pattern that, due to its severity or functional impact, requires specialized clinical treatment.
• Ongoing psychological and/or nutritional treatment at the time of enrollment, defined as regular sessions or an active treatment plan, regardless of treatment focus or therapeutic approach.
• Presence of active or medically unstable conditions, characterized by clinically significant symptoms, lack of medical follow-up, or recent changes in medication, that could interfere with participation in the intervention or substantially affect eating behavior or mood.
• Significant functional impairment that, in the clinical judgment of the research team, would limit the participant's ability to engage safely and consistently in the intervention.

Sponsors & Collaborators

• Universidad Catolica de Temuco: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Universidad Católica de Temuco

Temuco, La Araucanía, 4780000, Chile

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia; Emotional Regulation

Interventions

Food

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Neli Escandon, PhD

  Universidad Catolica de Temuco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neli Escandon, PhD

CONTACT

+56452685078; nescandon@uct.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychology and Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)