Severe Obesity and Eating Habits (OSCAR) (OSCAR)

October 12, 2021 updated by: Centre Hospitalier Arras

Eating Disorders Non Otherwise Specified (EDNOS) in a Population of Subjects Consulting for Severe Obesity (BMI> 35) : Prevalence and Characterization Study

In anorexia nervosa,the eating disorder (ED) is the cause of thinness. In severe obesity, the overweight is a symptom. This symptom, however, is only the consequence of possibly deregulated eating behavior. The literature, focusus a specified ED of DSM-V: Binge Eating Disorder (BED) or Binge Eating, whom estimated prevalence in the severely obese population varies from 1.4 to 49% depending on the studies. The other ED, called unspecified ED (or EDNOS for Eating Disorder Non Otherwise Specified in the English literature), are much less known.

The main objective of this study is to assess the prevalence rate of unspecified ED (EDNOS or "non-BED ED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a General Hospital Center CSO (Specialized Obesity Center) using an adapted version of the QEWP-R, called the QEWP-RA.

Study Overview

Status

Completed

Detailed Description

When it comes to weight problems, no one today disputes with anorexia nervosa that thinness is only a symptom. Thinness is the consequence of a multifactorial food restriction, in other words the consequence of an Eating Behavior Disorder (ED). The diagnosis of anorexia nervosa is made relative to the presence of diagnostic criteria listed in the DSM-V (Diagnostic and Statistical Manual V). Everyone recognizes the need for multidisciplinary care that is not limited to the prescription of re-nutrition. Imposing an increase in energy intake has never been enough to cure patients with anorexia. The multidisciplinary support offered to these subjects also seeks to understand and treat the biopsychosocial determinants that perpetuate the mechanisms of food restriction and most of the therapeutic support is based on a psychotherapeutic, individual and / or family approach. The excess weight of subjects with severe obesity (Body Mass Index> 35) suffers from a lower etiopathogenic consideration. In obese people, excess weight is, too often, considered more as the problem to be treated than as the consequence of a more complex problem. Thus, the main therapeutic means still currently used are based on simplistic thermodynamic fundamentals and are based on an imposed food restriction (diet) or even undergone (bariatric surgery procedures).

The main objective of this study is to assess the prevalence rate of unspecified ED (EDNOS or "non-BED ED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a General Hospital Center CSO (Specialized Obesity Center) using an adapted version of the QEWP-R, called the QEWP-RA (questionnaire on eating and weight pattern-revised and modified).

The primary endpoint will be the prevalence rate of ED not specified in the QEWP-RA.

Prospective, single-center, non-interventional study involving the human person (Category 3 of the Jardé law).

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Arras, France, 62000
        • Arras General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe obesity (BMI> 35) who consult for the first time to lose weight at the Arras Hospital Nutrition Unit

Description

Inclusion Criteria:

  • Age ≥ 18 years old and <or = at 65 years old;
  • With severe obesity (BMI> 35);
  • First consultation at the Arras Hospital Nutrition Unit.

Non inclusion Criteria:

  • Patients who have already undergone a nutrition consultation at Arras hospital;
  • Oligophrenic patients;
  • Patients under guardianship;
  • Patients who cannot read or write;
  • Participation in an interventional study modifying his eating behavior;
  • Person deprived of liberty;
  • Person under tutorship or curatorship;
  • Refusal to participate in the study;
  • Opposition to data processing;
  • Patient not affiliated to the social security scheme

Exclusion criteria :

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence rate of unspecified ED (EDNOS or "non-BED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a hospital. CSO general hospital center (Specialized Obesity Center).
Time Frame: 1 jour
The main objective of this study is to assess the prevalence rate of unspecified ED (EDNOS or "non-BED ED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a General Hospital Center CSO (Specialized Obesity Center) using an adapted version of the QEWP-R, called the QEWP-RA.
1 jour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the prevalence rate of "BED" subjects obtained from 3 different questionnaires (Questionnaire on Eating and Weight Pattern-R (QEWP-R), Eating Disorder Examination-Questionnaire (EDE-Q) and the Binge Eating Scale (BES)).
Time Frame: 1 jour
  • The QEWP-R (used to diagnose Binge Eating Disorder / Purging Bulimia Nervosa / Nonpurging Bulimia Nervosa)
  • The EDE-Q : 28 item self-report questionnaire. It concerns behaviors over a 28-day time period and retains the scoring system of 0-6: 0 = behaviour was absent and 6 = behaviour was present daily or to an extreme degree
  • The BES is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia.
1 jour
To compare the psychopathological profiles of "BED" subjects and "EDNOS" subjects (comparison of averages (Hospital Anxiety and Depression scale (HADS), Dutch Eating Behaviour Questionnaire (DEBQ),Emotional Eating Scale(EES)).
Time Frame: 1 jour
  • The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.
  • The DEBQ is a 33-item self-report questionnaire to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
  • The EES Self-reported frequency of emotional eating is measured with the 25-item EES. Each item is scored on a 5-point scale ranging from 1 (no desire to eat) to 5 (overwhelming desire to eat). Total scores range from 25-125. Higher scores indicate more emotional eating.The EES Scale yields 3 subscales: anger/ Frustration, anxiety and depression.
1 jour
To compare emotional eating profiles of "BED" subjects and "EDNOS" subjects (Comparison of emotional eating profiles (Hospital Anxiety and Depression scale (HADS), Dutch Eating Behaviour Questionnaire (DEBQ), Emotional Eating Scale(EES))).
Time Frame: 1 jour
  • The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.
  • The DEBQ is a 33-item self-report questionnaire to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
  • The EES Self-reported frequency of emotional eating is measured with the 25-item EES. Each item is scored on a 5-point scale ranging from 1 (no desire to eat) to 5 (overwhelming desire to eat). Total scores range from 25-125. Higher scores indicate more emotional eating.The EES Scale yields 3 subscales: anger/ Frustration, anxiety and depression.
1 jour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2020

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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