- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588610
Severe Obesity and Eating Habits (OSCAR) (OSCAR)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arras, France, 62000
- Arras General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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 |
|---|---|---|
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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.
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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
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1 jour
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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
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1 jour
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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
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1 jour
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Spitzer RL, Yanovski S, Wadden T, Wing R, Marcus MD, Stunkard A, Devlin M, Mitchell J, Hasin D, Horne RL. Binge eating disorder: its further validation in a multisite study. Int J Eat Disord. 1993 Mar;13(2):137-53.
- Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- de Zwaan M. Binge eating disorder and obesity. Int J Obes Relat Metab Disord. 2001 May;25 Suppl 1:S51-5. doi: 10.1038/sj.ijo.0801699.
- Hudson JI, Lalonde JK, Berry JM, Pindyck LJ, Bulik CM, Crow SJ, McElroy SL, Laird NM, Tsuang MT, Walsh BT, Rosenthal NR, Pope HG Jr. Binge-eating disorder as a distinct familial phenotype in obese individuals. Arch Gen Psychiatry. 2006 Mar;63(3):313-9. doi: 10.1001/archpsyc.63.3.313.
- Yanovski SZ. Binge eating disorder: current knowledge and future directions. Obes Res. 1993 Jul;1(4):306-24. doi: 10.1002/j.1550-8528.1993.tb00626.x.
- Striegel-Moore RH, Dohm FA, Solomon EE, Fairburn CG, Pike KM, Wilfley DE. Subthreshold binge eating disorder. Int J Eat Disord. 2000 Apr;27(3):270-8. doi: 10.1002/(sici)1098-108x(200004)27:33.0.co;2-1.
- Striegel-Moore RH, Wilson GT, Wilfley DE, Elder KA, Brownell KD. Binge eating in an obese community sample. Int J Eat Disord. 1998 Jan;23(1):27-37. doi: 10.1002/(sici)1098-108x(199801)23:13.0.co;2-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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