Clinical trial NCT02431195: Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Keywords: obesity
bariatric surgery
physical activity
eating habits
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Higher-order cognitive disorders
* Language difficulties in understanding
* Living alone or living without any family member

Primary outcomes:
measure: Changes from baseline in different eating habits and culinary items in responses to questionnaires
timeFrame: At 3 month, 6 month and 12 month
Secondary outcomes:
measure: Changes from baseline in different items about physical activity in responses to questionnaires
timeFrame: At 3 month, 6 month and 12 month
measure: Quality of life measured by scores
timeFrame: At baseline, 3 month, 6 month and 12 month
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Department of Nutrition, CHU Ambroise Paré
state: Hauts Des Seine
Study officials:
affiliation: CHU Ambroise Paré
name: Sébastien Czernichow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Ambroise Paré
name: Kàtia Lurbe-Puerto, PhD
role: STUDY_DIRECTOR
References: