Dissociative Disorders in Obesity (Dissobe) | NCT05081778

Studies
Dissociative Disorders in Obesity (Dissobe)

NCT05081778

Sponsor

Ramsay Générale de Santé

Status

Completed

Last Update Posted

Oct 18, 2021Actual

Enrollment

240Actual

Phase

Not provided

Conditions

Obesity
Dissociative Disorder

Interventions

Obese patient following a medical course

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2019Actual

Primary Completion Date

Jul 5, 2019Actual

Completion Date

Dec 5, 2019Actual

First Submitted Date

Oct 4, 2021

First Submission Date that Met QC Criteria

Oct 4, 2021

First Posted Date

Oct 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2021

Last Update Posted Date

Oct 18, 2021Actual

Name	Class
European Clinical Trial Experts Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

THe aim of this study is to determine the frequency of dissociative tendencies in the obese population treated at the CELIOBE (Liberal Center for Obesity Support) at Hôpital Privé La Louvière among patients consulting for the first time and looking for a medical or surgical course. The DES scale of Carlson and Putman will be used.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese patient following a medical course			Behavioral: Obese patient following a medical course
Obese patient following a surgical course			Behavioral: Obese patient following a medical course

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obese patient following a medical course	Behavioral	Questionnaires for the assessment of dissociative disorders in obese patients : DES scale of Carlson and Putman, SDQ-20 of Nijenhuis, comorbidities, Dutch Eating Behaviour Questionnaire (DEBQ), questionnaire of Rosenberg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of dissociative tendencies	The degree of dissociative tendencies measured by the Carlson and Putman DES scale.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18
Obesity defined by a Body Mass Index (BMI) ≥ 30 kg / m2
Patient seen in consultation at CELIOBE for the first time for the management of an overweight problem, wishing for surgical or medical care
Patient having been informed and not opposing to this research
Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Psychotic antecedents: Schizophrenia, Schizoaffective disorders, Hallucinatory psychoses, Brief psychotic attacks
Addictive behaviors (alcohol, drug addiction)
Drug use
Taking antipsychotics and mood stabilizers
Dissociative identity disorders proven
Bipolar disorders or severe mental illness
Understanding troubles
Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent
Pregnant, breastfeeding or parturient woman

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Obese population with a body mass index over 30kg/m2 Minimum age : 18 years-old Patients consulting for the first time at CELIOBE and wishing a medical or surgical course.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital privé La Louvière		Lille	Haut de France	59800	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D004213	Dissociative Disorders

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided