NCT07201662

Brief Summary

Obesity, recognized as a chronic disease by the WHO since 1998, affects 22.1% of adults in the Hauts-de-France region. Beyond the physiological aspects, it is associated with psychological difficulties, particularly eating disorders such as binge eating disorder (BED), as well as interpersonal difficulties related to empathy. Empathy, which consists of cognitive (decoding emotion) and affective (sharing emotion) dimensions, appears to be reduced in obese adults compared to adults of normal weight. However, existing research remains limited and heterogeneous. It is therefore essential to explore the links between obesity, cognitive and affective empathy in greater detail, taking into account the role of BED, in order to better understand their impact on interpersonal relationships.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Nov 2025Mar 2027

First Submitted

Initial submission to the registry

August 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

August 29, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

obesitybinge eating disorderEmpathy

Outcome Measures

Primary Outcomes (1)

  • MET-Core

    Compare cognitive empathy skills obtained on the MET-Core between participants who are obese

    Enrollment

Secondary Outcomes (2)

  • Empathy skills

    Enrollment

  • Interpersonal difficulties assessed with the Inventory of Interpersonal Problems - Circumplex Scales (IIP-C)

    Enrollment

Study Arms (1)

Patient Nutritional Rehabilitation

EXPERIMENTAL

Patients presenting for a "standard" stay, preparation for bariatric surgery, or post-surgical follow-up in the Nutritional Rehabilitation department

Other: Condensed and Revised Multifaceted Empathy TestOther: Hospital Anxiety and Depression ScaleOther: Interpersonal Reactivity IndexOther: Vicarious Distress QuestionnaireOther: Binge Eating Scale

Interventions

A self-administered scale with 14 items, divided into two subscales of seven items, used to detect the presence of depression and anxiety. Non-cases or asymptomatic individuals (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11). The administration time is approximately 5 minutes.

Patient Nutritional Rehabilitation

The Interpersonal Reactivity Index (Davis, 1980; Guttman \& Laporte, 2002) is a 28-item self-report questionnaire measuring four dimensions of empathy: fantasy, perspective taking, empathic concern, and personal distress. Each item is rated on a 1-to-5 scale and provides a subscore for each dimension, with no overall total score. Administration takes approximately 5 minutes.

Patient Nutritional Rehabilitation

Experimental emotional decoding task that measures the cognitive and affective dimensions of empathy based on performance (Edele et al., 2013; Grynberg et al., 2017).Participants view 40 photos of faces expressing either a positive or negative emotion and must identify the emotion (decoding) and then rate on a 1-9 scale the extent to which they share it (emotional sharing). The task lasts approximately 10 minutes on average.

Patient Nutritional Rehabilitation

The Vicarious Distress Questionnaire (Grynberg et al., 2012) is an 18-item self-report scale assessing distress experienced in response to others' suffering and its impact on prosocial behaviors. It includes three dimensions-distress, support, and avoidance-each yielding a specific subscore. Administration takes approximately 5 minutes.

Patient Nutritional Rehabilitation

The Binge Eating Scale (Gormally et al., 1982; Brunault et al., 2016) is a 16-item self-report questionnaire assessing the behavioral, emotional, and cognitive manifestations of binge eating disorder (BED) according to DSM-V criteria. The total score (0-46) reflects symptom severity and can be interpreted dimensionally or categorically (≥ 18 indicating significant symptomatology). Administration takes approximately 5 minutes.

Patient Nutritional Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • BMI ≥ 30 kg/m2
  • French-speaking
  • Enrolled in nutritional rehabilitation
  • Written consent signed by the patient
  • Affiliation with a social security system

You may not qualify if:

  • Insufficient proficiency in the French language
  • Minor patients, or patients under legal protection measures or deprived of liberty
  • Lack of health insurance coverage
  • Refusal to participate in the study
  • Presence of neurological disorders
  • Presence of cognitive disorders
  • Presence of psychiatric disorders
  • Presence of eating disorders such as anorexia or bulimia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique les Peupliers

Villeneuve-d'Ascq, France

Location

MeSH Terms

Conditions

ObesityOverweightBinge-Eating Disorder

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single-center type 2 trial (interventional study with minimal risks and constraints)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

October 1, 2025

Study Start

November 5, 2025

Primary Completion

November 5, 2025

Study Completion (Estimated)

March 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations