Obesity, MorbidPHENOBEQOL73NCT06951893
Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
A study testing Hospital Anxiety and Depression Scale, Dutch Eating Behaviour Questionnary and Impact of Weight on Quality Of Life in people with Obesity, Morbid and Obesity and Overweight, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Obesity and Overweight, Bariatric Surgery
- What is being tested?
- Hospital Anxiety and Depression Scale, Dutch Eating Behaviour Questionnary and Impact of Weight on Quality Of Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2025to 9 Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient > 18years old
- Integrated into the GEROM73 surgical program and starting the intra-hospital program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Métropole Savoie
Chambéry, Savoie, 73011
+33479965999, fabienne.prieur@ch-metropole-savoie.fr
About this study
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.
Read more
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.
- Conditions
- Obesity, Morbid, Obesity and Overweight, Bariatric Surgery, Bariatric Surgery Patients, Bariatric Surgery Patient, Bariatric Surgery (Sleeve Gastrectomy )
- Being tested
- Hospital Anxiety and Depression Scale, Dutch Eating Behaviour Questionnary, Impact of Weight on Quality Of Life, body schema, body mass index
- Keywords
- GEROM73, PHENOBEQOL73
- Medical subject headings
- Obesity, Morbid, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety and Depression ScaleOther
It is a self-assessment questionnaire to identify the existence of anxious and depressive symptoms and to assess their severity.
Dutch Eating Behaviour QuestionnaryOther
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
Impact of Weight on Quality Of LifeOther
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.
body schemaOther
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.
body mass indexOther
patient weighing at each visit
waist sizeOther
waist size measure
| Study group | Role | What they receive |
|---|---|---|
| phenotype of patients during the GEROM73 program | Experimental | Anxiety, Depression, Eating disorders, Impact of Weight on Quality Of Life.Patients' weight, Body Mass index and Body schema Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month befre surgery to 24 month post surgery
Secondary outcomes (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.
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.
Measured: 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.
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:
- emotional eating,
- external eating,
- restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
Measured: 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.
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.
Measured: 12, 18 and 24 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start17 Jun 2025
- Primary completion9 Sep 2030 (estimated)
- Study completion9 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- each patient will complete questionary 6month before surgery, and then 12, 18 and 24 months after the surgery
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile BOSSU ESTOUR, Principal investigator, CH Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951893
- Sponsor's protocol ID
- 2024-A02695-42
- Acronym
- PHENOBEQOL73
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No