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

Obesity Clinical Trial

— SOCIOB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431195
• Other study ID #: 13SCW-SOCIOB
• Status: Completed
• Start date: March 2015
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Locations

Country	Name	City	State
France	Department of Nutrition, CHU Ambroise Paré	Boulogne Billancourt	Hauts Des Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 month, 6 month and 12 month
Secondary	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.	At 3 month, 6 month and 12 month
Secondary	Quality of life measured by scores	Quality of life will be measured by scores at baseline, 3 month, 6 month and 12 month	At baseline, 3 month, 6 month and 12 month