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Eating DisordersOSCARNCT04588610

Severe Obesity and Eating Habits (OSCAR)

An observational study of Eating Disorders and Severe Obesity, run by Centre Hospitalier Arras at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Eating Disorders, Severe Obesity
How many people
150 participants
Where
1 siteFrance
Study dates
29 Aug 2020to 29 Sep 2021
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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;
Show all 14Show fewer
  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

France1 site

  • Arras General Hospital

    Arras, 62000

Other trials in France

About this study

Official title: 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.

Read the 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).

Medical subject headings
Feeding and Eating Disorders, Obesity, Morbid

What is being measured

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

  1. 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).

    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.

    Measured: 1 jour

Secondary outcomes (3)

  1. 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)).

    • 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.

    Measured: 1 jour

  2. 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)).

    • 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.

    Measured: 1 jour

  3. 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))).

    • 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.

    Measured: 1 jour

Timeline

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

  1. First posted19 Oct 2020
  2. Study start29 Aug 2020
  3. Primary completion29 Sep 2021
  4. Study completion29 Sep 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04588610
Sponsor's protocol ID
2017-04
Acronym
OSCAR
Status last verified
Oct 2021
First submitted
2 Oct 2020
Last updated
13 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11466589

  • 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.

    PubMed 16520437

  • 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.

    PubMed 7080884

  • 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.

    PubMed 16350580

  • 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.

    PubMed 8477283

  • 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.

    PubMed 10694712

  • 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.

    PubMed 9429916

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders and Severe Obesity, run by Centre Hospitalier Arras 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 14 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT04588610, which also lists 7 linked publications.

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 13 Oct 2021.

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