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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00145-42 | Other Identifier | ID-RCB number |
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| Name | Class |
|---|---|
| Maison de la Maladie Chronique | UNKNOWN |
| Institut d'Etude de la Maladie Chronique | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients | Experimental | Patients suffering from obesity defined by a BMI ≥ 30 and following the Chronic Disease Unit care pathway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires and focus group | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie LAFOND | Contact | 04 83 77 20 62 | +33 | sophie.lafond@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurelie GAZAGNE, Dietician | MMC / IEMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MMC | Recruiting | La Garde | Var | 83130 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| 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:
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |