About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient identified by the network or referred by a healthcare professional,
Patient aged 18 or over,
Patient suffering from obesity defined by a BMI ≥ 30,
Patient who understands and speaks French.
Disqualifiers
Opposition of the patient to participation in the study,
Pregnant, parturient or breast-feeding woman,
Patient undergoing bariatric surgery,
Patient under judicial protection (guardianship, curatorship, etc.) or safeguard of justice,
Trial design
Single group
Treatments tested in this trial
Questionnaires and focus group
BehavioralTo 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
To assess disruptions in care
Number of premature study exits and their causes
Other outcomes
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead sponsor
Maison de la Maladie Chronique
Collaborator
Institut d'Etude de la Maladie Chronique
Collaborator