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Идёт набор NCT06951893

Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery

Без фазы С лечением Obesity, Morbid Obesity and Overweight Bariatric Surgery Bariatric Surgery Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hospital Anxiety and Depression Scale, Dutch Eating Behaviour Questionnary, Impact of Weight on Quality Of Life, body schema.
Кому может быть актуально
Состояния в реестре: Obesity, Morbid, Obesity and Overweight, Bariatric Surgery, Bariatric Surgery Patients. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to identify pre-operative phenotypic determinants predictive of quality of life trajectories in post-bariatric surgery patients. In addition, this study will have as a secondary objective the highlighting of a potential link between post-surgery quality of life trajectories and those of anxiety/depression scores, eating behaviors and body mass indices. This study will be conducted during the usual care of patients undergoing the GEROM73 program, lasting a total of 30 months. The GEROM73 program includes care for the six months preceding bariatric surgery and the 24 months following surgery. This program supports patients throughout their bariatric care.. Throughout the GEROM73 program, patients will complete questionnaires on anxiety, depression, eating disorders, Impact of Weight on Quality Of Life. Patients' weight, body mass index and body schema will also be measured throughout the GEROM program.

Вмешательства

  • Другое Hospital Anxiety and Depression Scale
    It is a self-assessment questionnaire to identify the existence of anxious and depressive symptoms and to assess their severity.
  • Другое Dutch Eating Behaviour Questionnary
    It allows the assessment of 3 distinct factors of eating behavior: cognitive restriction, emotional eating and externality. This tool was developed to better characterize the eating habits of obese subjects. 10min
  • Другое Impact of Weight on Quality Of Life
    The EQVOD is a validated French scale created from the Impact of Weight on Quality of Life (IWQOL) questionnaire. This self-administered questionnaire is specific to the sociocultural factors of obesity and its dietary treatment in France. The questionnaire is composed of five dimensions: physical impact (11 items), psychosocial impact (11 items), impact on sexual life (4 items), dietary well-being (5 items), and experience of diet/dietetics (5 items). The total number of items is 36.
  • Другое body schema
    Tactile assessment of the body schema using a motorized caliper applied to different parts of the individual's body. The caliper is connected to a touch pad on which the person can report the difference felt between the two pressure points on their skin, using their thumb and index finger.
  • Другое body mass index
    patient weighing at each visit
  • Другое waist size
    waist size measure

Первичные конечные точки

  • Time trajectories of EQVOD score during the 24 months post-surgery from measurements at M12, M18 and M24 according to phenotypic characteristics measured during the final pre-surgical assessment (M-1 of bariatric surgery) [Срок оценки: one month befre surgery to 24 month post surgery]
Вторичные конечные точки (3)
  • quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to anxiety and depression measured at 12, 18 and 24 months. [Срок оценки: 12, 18 and 24 month after surgery]
  • quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to Dutch Eating Behavior measured at 12, 18 and 24 months. [Срок оценки: 12, 18 and 24 months after surgery]
  • quality of life trajectory groups defined by the analysis of the primary outcome measure, comparated to Impact of Weight on Quality Of Life at 12, 18 and 24 months. [Срок оценки: 12, 18 and 24 month after surgery]

Критерии участия

Критерии включения

  • patient > 18years old
  • Integrated into the GEROM73 surgical program and starting the intra-hospital program

Критерии исключения

  • Patients in a state of psychiatric decompensation
  • Patients with cognitive disorders
  • Patients with difficulties understanding the French language, spoken or written
  • Pregnant, parturient, or breastfeeding women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Métropole Savoie — Chambéry

Идентификаторы

NCT: NCT06951893 · CHMS24006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗