Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members

Completed

• Conditions: Obesity; Bariatric Surgery

• Registration Number: NCT02431195
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-30
• Primary Completion: 2019-02
• Status Verified: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline in different eating habits and culinary items in responses to questionnaires	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.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in different items about physical activity in responses to questionnaires	At 3 month, 6 month and 12 month	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.
Quality of life measured by scores	At baseline, 3 month, 6 month and 12 month	Quality of life will be measured by scores at baseline, 3 month, 6 month and 12 month

Trial Locations

Locations (1)

Department of Nutrition, CHU Ambroise Paré; 🇫🇷 Boulogne Billancourt, Hauts Des Seine, France