Rapid Eating Is Linked to Emotional Eating in Obese Women... | NCT03949595

Studies
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery

NCT03949595

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

May 14, 2019Actual

Enrollment

116Actual

Phase

Not provided

Conditions

Obesity

Interventions

Data collection

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

May 2019

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

Nov 1, 2011Actual

Primary Completion Date

Mar 1, 2014Actual

Completion Date

Apr 1, 2014Actual

First Submitted Date

May 13, 2019

First Submission Date that Met QC Criteria

May 13, 2019

First Posted Date

May 14, 2019Actual

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

May 13, 2019

Last Update Posted Date

May 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 the study was to analyse eating rate in comparison to other aspects of eating habits in women suffering from severe/massive obesity.

Detailed Description

Eating rate is associated with BMI and weight gain in various populations and is a factor modulating the risk of complications after bariatric surgery. The aim of the present study is to determine whether common difficulties to change eating rate in subjects with obesity candidate to bariatric surgery could be due to more extensive abnormalities in eating behaviour.

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

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases		women suffering from severe/massive obesity	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other		cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eating Rate	Eating Rate was assessed by using an analog scale from 1 (slowest eating) to 10 (fastest eating)	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

inclusion criteria :

BMI ≥ 35 kg/m
responses to a self-administered questionnaire distributed between November 2011 and March 2014 to female patients attending a nutrition consultation for overweight, or attending an outpatient visit prior to bariatric surgery, both within the Champagne-Ardenne Specialized Obesity Clinic, at the University Hospital Robert Debré in Reims, France
Patients who agree to participate to the study
Major patient

exclusion criteria :

Patient under law protection
Minor patient
Patients with uncontrolled diabetes (HbA1c ≥ 8.0% at inclusion) or those treated with glucagon-like peptide-1 (GLP-1) receptor antagonists, as well as patients treated by glucocorticoids (their current treatment was systematically reported)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Women suffering from obesity and their eating habits

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28871527	Background	Canterini CC, Gaubil-Kaladjian I, Vatin S, Viard A, Wolak-Thierry A, Bertin E. Rapid Eating is Linked to Emotional Eating in Obese Women Relieving from Bariatric Surgery. Obes Surg. 2018 Feb;28(2):526-531. doi: 10.1007/s11695-017-2890-4.

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

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care