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Completed

NCT Number: NCT02431195

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition, CHU Ambroise Paré

Boulogne-Billancourt, Hauts Des Seine, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women

Acronym: SOCIOB

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2015
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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