NCT06538220 Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients
| NCT ID | NCT06538220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 133 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 133 participants in total. It began in 2024-10-16 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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
Inclusion Criteria: 1. Patient identified by the network or referred by a healthcare professional, 2. Patient aged 18 or over, 3. Patient suffering from obesity defined by a BMI ≥ 30, 4. Patient who understands and speaks French. Exclusion Criteria: 1. Opposition of the patient to participation in the study, 2. Pregnant, parturient or breast-feeding woman, 3. Patient undergoing bariatric surgery, 4. Patient under judicial protection (guardianship, curatorship, etc.) or safeguard of justice, 5. Patients with unstable psychiatric disorders, 6. Patients on neuroleptics, 7. Any other reason which in the opinion of the investigator, could interfere with the evaluation of the study objectives.
Contact & Investigator
Aurelie GAZAGNE, Dietician
STUDY DIRECTOR
MMC / IEMC
Frequently Asked Questions
Who can join the NCT06538220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06538220 currently recruiting?
Yes, NCT06538220 is actively recruiting participants. Contact the research team at sophie.lafond@ch-toulon.fr for enrollment information.
Where is the NCT06538220 trial being conducted?
This trial is being conducted at La Garde, France.
Who is sponsoring the NCT06538220 clinical trial?
NCT06538220 is sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. The principal investigator is Aurelie GAZAGNE, Dietician at MMC / IEMC. The trial plans to enroll 133 participants.
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