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临床试验/NCT02431195
NCT02431195已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Changes from baseline in different eating habits and culinary items in responses to questionnaires

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Changes from baseline in different eating habits and culinary items in responses to questionnaires

时间窗: 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.

次要结局

  • Changes from baseline in different items about physical activity in responses to questionnaires(At 3 month, 6 month and 12 month)
  • Quality of life measured by scores(At baseline, 3 month, 6 month and 12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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