ObesityBS-WomenNCT03949595
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery
An observational study of Obesity, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Data collection
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2011to 1 Apr 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women suffering from obesity and their eating habits
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Data collection
- Keywords
- Obese, Food behaviour, Eating rate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| cases | women suffering from severe/massive obesity Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Rate
Eating Rate was assessed by using an analog scale from 1 (slowest eating) to 10 (fastest eating)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Nov 2011
- Primary completion1 Mar 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949595
- Sponsor's protocol ID
- 2018Ao004
- Acronym
- BS-Women
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28871527
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03949595
- Acronym / sponsor ID
- BS-Women / 2018Ao004
- Conditions
- Obesity
- Keywords
- Obese, Food behaviour, Eating rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: Data collectionwomen suffering from severe/massive obesity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women suffering from obesity and their eating habits
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection | Other | cases |
Primary outcome
Eating Rate
Time frame: Day 0
Eating Rate was assessed by using an analog scale from 1 (slowest eating) to 10 (fastest eating)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Background: PubMed 28871527Canterini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by CHU de Reims 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 4 inclusion and 3 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 14 May 2019. 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?
Eating Rate (time frame: Day 0). 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 NCT03949595, which also lists 1 linked publication.
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 14 May 2019.