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Obesity &Amp;Amp; OverweightEMBED_OBNCT07201662

The Role of Empathy in the Links Between Binge Eating Disorder and Interpersonal Difficulties

A study testing Condensed and Revised Multifaceted Empathy Test, Hospital Anxiety and Depression Scale and Interpersonal Reactivity Index in people with Obesity &Amp;Amp; Overweight, run by Clinique de la Mitterie at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity &Amp;Amp; Overweight
What is being tested?
Condensed and Revised Multifaceted Empathy Test, Hospital Anxiety and Depression Scale and Interpersonal Reactivity Index
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteFrance
Study dates
5 Nov 2025to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clinique les Peupliers

    Villeneuve-d'Ascq

Other trials in France

About this study

Official title: Role of Empathy in the Links Between Binge Eating Disorder and Interpersonal Difficulties in the Context of Obesity in a Clinical Population

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.

Read the detailed description

Obesity has been recognized as a chronic disease by the World Health Organization since 1998. In the Hauts-de-France region, obesity affects 22.1% of adults.

Psychologically, it has been noted that obese individuals may experience intrapersonal difficulties (eating disorders such as binge eating disorder [BED], i.e., bulimia nervosa) and interpersonal difficulties, such as empathy disorders. Empathy is generally defined as a multidimensional concept, comprising two dimensions known as "cognitive" (decoding emotion) and "affective" (sharing emotion).

Empathic skills are significantly weaker in obese adults than in adults of normal weight. However, only ten studies were included in this research, and only two studies focused on affective empathy. In addition, the methodologies were highly heterogeneous (experimental tasks, self-assessment questionnaires). Therefore, the investigators believe it is essential to examine the links between obesity, cognitive empathy, and affective empathy in the adult population using a mixed methodology based on an experimental task and questionnaires. In addition, the investigators wish to examine the role of BED in explaining possible empathy disorders associated with obesity. Finally, the investigators wish to better understand the links between empathy difficulties and interpersonal difficulties.

Being tested
Condensed and Revised Multifaceted Empathy Test, Hospital Anxiety and Depression Scale, Interpersonal Reactivity Index, Vicarious Distress Questionnaire, Binge Eating Scale
Keywords
obesity, binge eating disorder, Empathy
Medical subject headings
Obesity, Overweight, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Condensed and Revised Multifaceted Empathy TestOther

    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.

  • Hospital Anxiety and Depression ScaleOther

    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.

  • Interpersonal Reactivity IndexOther

    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.

  • Vicarious Distress QuestionnaireOther

    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.

  • Binge Eating ScaleOther

    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.

Study groups in NCT07201662
Study groupRoleWhat they receive
Patient Nutritional RehabilitationExperimentalPatients presenting for a "standard" stay, preparation for bariatric surgery, or post-surgical follow-up in the Nutritional Rehabilitation department
Receives: Other: Condensed and Revised Multifaceted Empathy Test; Other: Hospital Anxiety and Depression Scale; Other: Interpersonal Reactivity Index; Other: Vicarious Distress Questionnaire; Other: Binge Eating Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MET-Core

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

    Measured: Enrollment

Secondary outcomes (2)

  1. Empathy skills

    Compare the empathy skills self-reported by participants with obesity, based on the presence or absence of symptoms suggestive of BED.

    Measured: Enrollment

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

    The IIP-C is a 64-item self-report questionnaire assessing interpersonal difficulties across eight sub-dimensions (each consisting of 8 items): Vindictive, Domineering, Intrusive, Overly Nurturant, Exploitable, Nonassertive, Socially Avoidant, and Cold.

    Each item is rated on a 5-point Likert scale (0 = not at all, 4 = extremely), reflecting the extent to which the statement represents a difficulty experienced by the participant in interpersonal relationships. For each sub-dimension, a mean score is computed, and a global score can also be calculated as the mean of all 64 items. Higher scores indicate greater interpersonal difficulties.

    The unit of measure will be the total IIP-C score (range: 0-4) and/or the subscale scores (range: 0-4). The average administration time is approximately 10 minutes.

    Measured: Enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start5 Nov 2025
  3. Primary completion5 Nov 2025
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Single-center type 2 trial (interventional study with minimal risks and constraints)
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07201662
Sponsor's protocol ID
2025-A00868-41
Other IDs
MR-P0010
Acronym
EMBED_OB
Status last verified
Jan 2026
First submitted
29 Aug 2025
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: No Plan Description for the moment

Questions about this trial

What is this clinical trial studying?

A study testing Condensed and Revised Multifaceted Empathy Test, Hospital Anxiety and Depression Scale and Interpersonal Reactivity Index in people with Obesity &Amp;Amp; Overweight, run by Clinique de la Mitterie at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MET-Core (time frame: Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07201662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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