NCT04588610

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

October 2, 2020

Last Update Submit

October 12, 2021

Conditions

Outcome Measures

Primary Outcomes (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.

    1 jour

Secondary Outcomes (3)

  • 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)).

    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)).

    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))).

    1 jour

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arras General Hospital

Arras, 62000, France

Location

Related Publications (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.

    PMID: 11466589BACKGROUND
  • 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.

    PMID: 16520437BACKGROUND
  • 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.

    PMID: 7080884BACKGROUND
  • 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.

    PMID: 16350580BACKGROUND
  • 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.

    PMID: 8477283BACKGROUND
  • 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.

    PMID: 10694712BACKGROUND
  • 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.

    PMID: 9429916BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersObesity, Morbid

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 19, 2020

Study Start

August 29, 2020

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

October 13, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations