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

Browse trials for

• Obesity, Morbid 941
• Obesity 11,522
• Overweight 3,599

Keywords

• GEROM73
• PHENOBEQOL73

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 165 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Lead sponsor

Centre Hospitalier Metropole Savoie is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Study arms

• Experimental
  phenotype of patients during the GEROM73 program

  Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema

  Other: Hospital Anxiety and Depression Scale · Other: Dutch Eating Behaviour Questionnary · Other: Impact of Weight on Quality Of Life · Other: body schema · Other: body mass index · Other: waist size

Interventions

• OtherHospital Anxiety and Depression Scale

  It is a self-assessment questionnaire to identify the existence of anxious and depressive symptoms and to assess their severity.

• OtherDutch 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

• OtherImpact 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.

• Otherbody 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.

• Otherbody mass index

  patient weighing at each visit

• Otherwaist size

  waist size measure

Primary outcomes

1. 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)

   Trajectory identification using latent class mixed models to classify patients into distinct EQVOD score trajectories over the 24 months post-surgery. The relationship between the 7 pre-surgery phenotypic characteristics and membership in the different trajectory classes will be tested in a multinomial logistic regression.

   Time frame: one month befre surgery to 24 month post surgery

Secondary outcomes

1. 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.

   score of anxiety depression (HADS). The HAD (Hospital Anxiety and Depression Scale) assesses anxiety and depressive disorders (its use has been validated in French in the general population as well as in patients undergoing antidepressant treatment). This scale consists of 14 items rated from 0 to 3, of which 7 relate to anxiety and 7 to depression. Two scores are obtained and vary between 0 and 21. Interpretation takes into account two thresholds: the first, less than or equal to 7, corresponds to the absence of symptoms, and the second, greater than or equal to 11, indicates the presence of anxiety and/or depressive symptoms.

   Time frame: 12, 18 and 24 month after surgery

2. 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.

   Dutch Eating Behavior Questionnaire = DEBQ The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item self-report questionnaire developed by Van Strien et al. (1986), to assess three distinct eating behaviors in adults: 1. emotional eating, 2. external eating, 3. restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

   Time frame: 12, 18 and 24 months after surgery

3. 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.

   Impact of Weight on Quality Of Life : IWQOL It includes 36 items divided into five dimensions: physical, sexual, psychosocial,relationship with food, and experience of the diet. It allows us to assess the effects of dietary treatments on quality of life.. Each item is rated from 1 to 5, and each dimension is weighted to obtain a score out of 100. A high score indicates a good perceived quality of life related to obesity.

   Time frame: 12, 18 and 24 month after surgery

Other outcomes

1. Body schema measured at pre-surgical (M-6 and end of pre-operative course M-1) and post-surgical (M+12 and M+24) assessments.

   Body schema measured by SKIN. For each participant, an average difference between the perceived distance and the actual applied distance is calculated for each body part (thigh, abdomen, arm, shoulder (neutral zone)). A positive difference corresponds to an oversizing of the tactile surface of the body, while a negative difference corresponds to an undersizing of the tactile surface of the body

   Time frame: at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery

2. Body schema measured at pre-surgical (M-6 and end of pre-operative course M-1) and post-surgical (M+12 and M+24) assessments compared between the quality of life trajectory groups defined by the analysis of the primary judgment criterion

   Body schema measured by SKIN. For each participant, an average difference between the perceived distance and the actual applied distance is calculated for each body part (thigh, abdomen, arm, shoulder (neutral zone)). A positive difference corresponds to an oversizing of the tactile surface of the body, while a negative difference corresponds to an undersizing of the tactile surface of the body

   Time frame: at 6 and 1 month before surgery, and at 12, 18 and 24 months before surgery

Individual participant data

Plan to share: No