- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949595
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery (BS-Women)
May 13, 2019 updated by: CHU de Reims
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Reims, France
- Damien JOLLY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women suffering from obesity and their eating habits
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cases
women suffering from severe/massive obesity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Rate
Time Frame: Day 0
|
Eating Rate was assessed by using an analog scale from 1 (slowest eating) to 10 (fastest eating)
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2011
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
May 13, 2019
First Submitted That Met QC Criteria
May 13, 2019
First Posted (Actual)
May 14, 2019
Study Record Updates
Last Update Posted (Actual)
May 14, 2019
Last Update Submitted That Met QC Criteria
May 13, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018Ao004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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