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

NCT06538220 | Recruiting

• 2 other identifiers: 2022-CHITS-0042024-A00145-42
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Care pathway; Self-efficacy; Patient education; Obesity; Interdisciplinary; Self mangement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M3

  0 month and 6 months (M6)

• To assess whether the care pathway improves overall quality of life at M3 and M6

  0 month, 3 and 6 months

• Evaluate the effect of the treatment pathway on the patient's corpulence between M0 and M6.

  0 month and 6 months

• To assess disruptions in care

  6 months

• To study the socio-demographic and clinical characteristics of patients at M0

  0 month

Other Outcomes (2)

• To assess whether the care pathway proposed by Chronic Disease Unit improves obese patients' sense of self-efficacy between M0 and M6.

  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.

  0 month and 6 months

Study Arms (1)

Obese patients

EXPERIMENTAL

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

Behavioral: Questionnaires and focus group

Interventions

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.

Obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Patients with unstable psychiatric disorders,
• Patients on neuroleptics,
• Any other reason which in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• Maison de la Maladie Chronique: collaborator
• Institut d'Etude de la Maladie Chronique: collaborator
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

MMC

La Garde, Var, 83130, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires; Focus Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Aurelie GAZAGNE, Dietician

  MMC / IEMC

  STUDY DIRECTOR

Central Study Contacts

Sophie LAFOND

CONTACT

04 83 77 20 62; sophie.lafond@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 5, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)