Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients

NCT ID: NCT06538220

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2028-04-30

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, 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?

Detailed Description

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:

• M0: During this consultation, the investigating physician will obtain oral consent of patients to their participation in the research, resulting in a research consultation lasting around 45 minutes and including questionnaires completion: quality of life (SF-12), personal efficacy scale (GSES), "Specific self Effecicacy related to Weight Management" (SEWM), Rosenberg self-esteem, body image satisfaction (QIC), state of anxiety and depression (HAD).
• M3: Follow-up visit with completion of SF-12, GSES, Rosenberg and QIC questionnaires.
• M6: Follow-up visit with completion of the same questionnaires as at M0 plus the Chronic Disease Unit satisfaction questionnaire, and end of research.

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Obese patients

Patients suffering from obesity defined by a BMI ≥ 30 and following the Chronic Disease Unit care pathway

Group Type: EXPERIMENTAL

Questionnaires and focus group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maison de la Maladie Chronique

UNKNOWN

Sponsor Role: collaborator

Institut d'Etude de la Maladie Chronique

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelie GAZAGNE, Dietician

Role: STUDY_DIRECTOR

MMC / IEMC

Locations

MMC

La Garde, Var, France

Site Status: RECRUITING

Countries

France

Central Contacts

Sophie LAFOND

Role: CONTACT

sophie.lafond@ch-toulon.fr

04 83 77 20 62 ext. +33

Facility Contacts

Aurelie GAZAGNE, Dietetician

Role: primary

aurelie.gazagne@ch-toulon.fr

0631397836 ext. +33

Other Identifiers

2024-A00145-42

Identifier Type: OTHER

Identifier Source: secondary_id

2022-CHITS-004

Identifier Type: -

Identifier Source: org_study_id