Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients
NCT Number: NCT06538220
Acronym: EVAMMACH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: BEHAVIORAL: Questionnaires and focus group
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Maison de la Maladie Chronique|Institut d'Etude de la Maladie Chronique
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 133
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2026-08
Locations: MMC, La Garde, Var, 83130, France

Summary:
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, programme 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?

Primary Outcome Measures: 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, 0 month and 6 months (M6)
Secondary Outcome Measures: 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, 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, 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, 0 month and 6 months|To assess disruptions in care, Number of premature study exits and their causes, 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, 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., 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., 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, 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, 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, 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 \[0 : not at all satisfied;10 : completely satisfied\], 6 months
Other Outcome Measures: 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, 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, 0 month and 6 months