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

June 18, 2019 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts Des Seine
      • Boulogne Billancourt, Hauts Des Seine, France, 92100
        • Department of Nutrition, CHU Ambroise Paré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3 month, 6 month and 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in different items about physical activity in responses to questionnaires
Time Frame: 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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Sébastien Czernichow, MD, PhD, CHU Ambroise Pare
  • Study Director: Kàtia Lurbe-Puerto, PhD, CHU Ambroise Pare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13SCW-SOCIOB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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