An interventional study of Questionnaires and focus group in Obesity, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Not applicable, Interventional, and Basic science
Obesity is a chronic and progressive disease medically defined as an increase in body fat, with consequences for physical, psychological and social well-being. With an estimated prevalence of 17% in France, obesity and its management remain a major public health issue. Projections by the World Health Organisation (WHO) show that the prevalence of non-communicable diseases, including obesity, is set to rise again by 2030 in all European countries.
To support patients and prevent obesity development, the French National Authority for Health (HAS) advocates change in practices and places patient education at the heart of care. The management of chronic diseases such as obesity must be offered on a long-term basis, adapting to complications onset, and patients must become active players in their treatment and the proposed care pathway. However, our experience shows that patients have difficulty finding their way around a care pathway and identifying the medical or paramedical resources that could help them to set their health goals and initiate change.
That's why the Var region has developed the "Chronic Disease Unit", which offers coordinated, adapted and individualised care pathways for patients suffering from chronic illnesses, including obesity; therapeutic education and the psychosocial dimension are at the heart of the Chronic Disease Unit approach. Depending on their psychosocial skills, each patient will be encouraged to develop skills at their own pace, but also to become autonomous in managing their illness and taking part in the healthcare decisions about them. To be autonomous, a patient must not only know what to do, but also feel able to do it, i.e. develop a sense of self-efficacy. When they have the necessary skills and believe in their abilities, patients are more likely to adopt health-promoting behaviours. While obesity generally seems to be linked to a low self-efficacy, the self-efficacy appears to be involved in weight management quality, commitment to a programme and the weight loss extent that results.
The aim of EVAMMACH study is to evaluate if the Chronic Disease Unit care pathway could promote obese patients' sense of self-efficacy and meet their expectations.
Patients will be identified at the Chronic Disease Unit during an orientation consultation with the dietician as part of routine practice. The clinician, who is also the study investigator, will then select patients who meet the protocol's inclusion criteria and inform them of the research. He will explain the study in detail and give them the information letter.
Patients will then be seen again in consultation during 3 visits:
Questionnaires will be completed in presence of the Chronic Disease Unit psychologist, to offer a discussion or treatment if necessary.
During M0 and M6 visits, some patients will participate in a focus group. An audio recording of the focus group sessions will be made after obtaining the participants' consent.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 133 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients suffering from obesity defined by a BMI ≥ 30 and following the Chronic Disease Unit care pathway
Behavioral: Questionnaires and focus group
To evaluate the Chronic Disease Unit care pathway, patients will respond to questionnaires : quality of life (SF-12), personal efficacy scale (GSES), "Specific self Efficacy related to Weight Management" (SEWM), Rosenberg self-esteem, body image satisfaction (QIC), state of anxiety and depression (HAD), Chronic Disease Unit satisfaction. Some patients will also participate to focus group.
To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M6
The self-efficacy will be determined by the overall score obtained on the General Self-Efficacy Scale (GSES) \[10;40\] A high score corresponds to important self efficacy
Time frame: 0 month and 6 months (M6)
To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M3
The self-efficacy will be determined by the overall score obtained on the General Self-Efficacy Scale (GSES) \[10;40\] A high score corresponds to important self efficacy
Time frame: 0 month and 6 months (M6)
To assess whether the care pathway improves overall quality of life at M3 and M6
The quality of life will be determined by the overall score obtained on the quality of life SF-12 questionnaire \[0;100\] A high score corresponds to better health/quality of life
Time frame: 0 month, 3 and 6 months
Evaluate the effect of the treatment pathway on the patient's corpulence between M0 and M6.
The patient's corpulence will be determined by BMI
Time frame: 0 month and 6 months
To assess disruptions in care
Number of premature study exits and their causes
Time frame: 6 months
To study the socio-demographic and clinical characteristics of patients at M0
Descriptive statistical analyses of socio-demographic and clinical characteristics at M0: * Socio-demographic data: age, sex, family and professional situation, education level, social disadvantage index. * Clinical data relating to obesity: existence of a known eating disorders or SCOFF score (eating disorders screening questionnaire), co-morbidities (diabetes, heart failure, obsessive-compulsive symptoms), BMI, diets followed, maximum and minimum weight achieved, etc. * Patient history: trauma, notorious violence and family history * Type of address (profession, town/city/network) * Current treatments: antidepressant, anxiolytic, etc. * Regular physical activity * Completion of ETP Obsession programme
Time frame: 0 month
Evaluate the effect of the Chronic Disease Unit care pathway between M0 and M6, in the subgroup of patients with Eating Disorders.
Number of compulsive binges per week assessed in the subgroup of patients with eating disorders.
Time frame: 0 month and 6 months
Evaluate patient adherence to the Chronic Disease Unit care pathway at M3 and M6
The number of workshops/consultations carried out over the number of workshops/consultations planned in the patient's objectives using the ETP Pilote software at M3 and M6.
Time frame: 3 and 6 months
Assess patients' self-esteem at M0, M3 and M6
The patients' self-esteem will be determined by the score obtained on Rosenberg self-esteem scale \[10;40\] A high score corresponds to high self-esteem
Time frame: 0 month, 3 and 6 months
Evaluate patient satisfaction with body image at M0, M3 and M6
The patient satisfaction with body image will be determined by the score of body image satisfaction (QIC) questionnaire \[19;95\] A high score corresponds to very good body satisfaction
Time frame: 0 month, 3 and 6 months
Assess patients' anxiety and depression at M0 and M6
The patients' anxiety and depression level will be determined by the score of state of anxiety and depression (HAD) scale \[0;42\] A high score corresponds to anxiety or depressive disorders presents
Time frame: 0 month and 6 months
Evaluate patient satisfaction with the Chronic Disease Unit care pathway at M6
Patient satisfaction will be determined by the responses of the Chronic Disease Unit satisfaction questionnaire \[0 : not at all satisfied;10 : completely satisfied\]
Time frame: 6 months
To assess whether the care pathway proposed by Chronic Disease Unit improves obese patients' sense of self-efficacy between M0 and M6.
The self-efficacy will be determined by the overall score obtained on "Specific self Efficacy related to Weight Management (SEWM) questionnaire \[0;400\] A high score corresponds to a high sense of self-efficacy
Time frame: 0 month and 6 months
Using the focus group method, to qualitatively assess the obese patient's experience before (M0) and after (M6) treatment in the Chronic Disease Unit care pathway.
Qualitative analysis of recorded focus group
Time frame: 0 month and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Apr 2028, 42 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 42 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer