ObesitySOCIOBNCT02431195
Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members
An observational study of Obesity and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.
Who may be able to join
- Aged ≥ 18 years
- Eligible to undergo bariatric surgery
- Post bariatric surgery follow-up visits will take place in the nutrition department
- Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)
- Informed consent signed
Who cannot join
- Higher-order cognitive disorders
- Language difficulties in understanding
- Living alone or living without any family member
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Nutrition, CHU Ambroise Paré
Boulogne-Billancourt, Hauts Des Seine, 92100
About this study
Official title: Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women
The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.
Read the detailed description
As secondary objectives, the study aims to:
- Describe the sociodemographic and clinical characteristics of post bariatric surgery patients.
- Assess changes in quality of life of the post-surgery patients.
- Explain changes of post-surgery in eating behavior and activity varied according to gender
- Explain changes of post-surgery in eating behavior and activity varied according to socio-economic conditions
- Explain changes of post-surgery in eating behavior and activity varied according to inter-generational relation
- Have a overview on the surgery as a turning point in the life of patients
- Estimate the relevant message of cares given to patients, in order to better adjust medical intervention, in conjunction with patients and their family members.
This is a prospective observational study. It will be performed in two university hospitals: CHU Ambroise Paré at Boulogne-Billancourt city and CHU Pitié Salpétrière at Paris, in nutrition department and metabolic surgery department. The study will involve collaboration of a team of social researchers.
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- obesity, bariatric surgery, physical activity, eating habits
- Medical subject headings
- Obesity, Motor Activity, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in different eating habits and culinary items in responses to questionnaires
Changes from baseline in different eating habits and culinary items in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's feeding practice should be in accordance with the postsurgical dietary guidelines.
Measured: At 3 month, 6 month and 12 month
Secondary outcomes (2)
Changes from baseline in different items about physical activity in responses to questionnaires
Changes from baseline in different items about physical activity in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's physical activity practice should be in accordance with the postsurgical guidelines.
Measured: At 3 month, 6 month and 12 month
Quality of life measured by scores
Quality of life will be measured by scores at baseline, 3 month, 6 month and 12 month
Measured: At baseline, 3 month, 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Czernichow, MD, PhD, Principal investigator, CHU Ambroise ParéKàtia Lurbe-Puerto, PhD, Study director, CHU Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431195
- Sponsor's protocol ID
- 13SCW-SOCIOB
- Acronym
- SOCIOB
- Status last verified
- Jun 2019
- First submitted
- 17 Mar 2015
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women
- ClinicalTrials.gov ID
- NCT02431195
- Acronym / sponsor ID
- SOCIOB / 13SCW-SOCIOB
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- obesity, bariatric surgery, physical activity, eating habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Apr 2015 (estimated)
- 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 main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.
Detailed description
As secondary objectives, the study aims to:
- Describe the sociodemographic and clinical characteristics of post bariatric surgery patients.
- Assess changes in quality of life of the post-surgery patients.
- Explain changes of post-surgery in eating behavior and activity varied according to gender
- Explain changes of post-surgery in eating behavior and activity varied according to socio-economic conditions
- Explain changes of post-surgery in eating behavior and activity varied according to inter-generational relation
- Have a overview on the surgery as a turning point in the life of patients
- Estimate the relevant message of cares given to patients, in order to better adjust medical intervention, in conjunction with patients and their family members.
This is a prospective observational study. It will be performed in two university hospitals: CHU Ambroise Paré at Boulogne-Billancourt city and CHU Pitié Salpétrière at Paris, in nutrition department and metabolic surgery department. The study will involve collaboration of a team of social researchers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- Eligible to undergo bariatric surgery
- Post bariatric surgery follow-up visits will take place in the nutrition department
- Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)
- Informed consent signed
Key exclusion criteria (3 listed)
- Higher-order cognitive disorders
- Language difficulties in understanding
- Living alone or living without any family member
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes from baseline in different eating habits and culinary items in responses to questionnaires
Time frame: At 3 month, 6 month and 12 month
Changes from baseline in different eating habits and culinary items in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's feeding practice should be in accordance with the postsurgical dietary guidelines.
2 secondary outcomes
Changes from baseline in different items about physical activity in responses to questionnaires
Time frame: At 3 month, 6 month and 12 month
Quality of life measured by scores
Time frame: At baseline, 3 month, 6 month and 12 month
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 19 Jun 2019.
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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.
Sébastien Czernichow, MD, PhD principal investigator
CHU Ambroise Paré
Kàtia Lurbe-Puerto, PhD study director
CHU Ambroise Paré
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 and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris 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 5 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 19 Jun 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?
Changes from baseline in different eating habits and culinary items in responses to questionnaires (time frame: At 3 month, 6 month and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2019.