OBEDIAM: Therapeutic Patient Education in Adults Living With Obesity, Diabetes, and Metabolic Disorders

Rationale:

Obesity is associated with several physical and psychological complications that can affect quality of life. Managing obesity requires an interdisciplinary, individualized, and person-centered approach. People living with obesity often have to make complex decisions related to diet, physical activity, sleep, and mental health. Many report not feeling sufficiently supported or equipped to manage their health on a daily basis, particularly due to weight stigma and barriers to accessing care. Therapeutic patient education (TPE) aims to support people living with a chronic illness in developing self-management skills and making informed decisions. In the context of obesity, structured educational interventions appear to promote the adoption of healthy behaviors and support an approach not exclusively focused on weight. This project aims to co-develop, with citizen partners and healthcare professionals, a therapeutic patient education (TPE) program for the population living with obesity, and then to evaluate its acceptability.

Hypothesis:

A patient education program co-developed with citizen partners and healthcare professionals is acceptable for people living with obesity, particularly in terms of accessibility and feasibility.

Main Objective:

The objective of this pilot study is to co-develop a patient education program for people living with obesity, adapted to the Quebec context, and then to assess its acceptability.

More specifically, the study aims to:

* Co-develop the content and modalities of the program in collaboration with citizen partners and healthcare professionals; * Explore participants' perceptions of the acceptability and feasibility of such a program; * Document the facilitators and barriers to its implementation in the Quebec context with patients and healthcare professionals.

Secondary Objectives

* Explore the effects of a patient education program for people living with obesity, using a pre/post-intervention comparison of patient-reported health data, including quality of life, self-efficacy, and use of healthcare resources. * Evaluate the feasibility of the study by documenting participant recruitment and retention over a 12-month period, as well as their participation in program activities. * Describe the engagement of healthcare professionals involved in the program's implementation.

Study Design:

The first phase aims to co-construct the patient education program adapted to the Quebec context. It is based on a participatory qualitative approach involving patient partners and healthcare professionals.

The second phase focuses on the implementation and evaluation of the patient education program's acceptability. It consists of a pilot study using a mixed-methods approach, including a pre/post-intervention quantitative component to explore the program's effects on quality of life, self-efficacy, and healthcare resource utilization, and a qualitative component to document the program's acceptability, the study's feasibility, and the facilitators and barriers to its implementation.

Research Procedures:

Study Population: The study population will consist of adults living with obesity receiving care in a Quebec healthcare setting.

Patient Recruitment: A convenience sample of approximately 30 patients will be recruited for the pilot phase of the study. Recruitment will take place in clinical settings specializing in obesity, particularly within the endocrinology and metabolic medicine clinics of the CHU de Québec. Healthcare professionals involved in these settings will identify potentially eligible patients and briefly present the project to them. Interested individuals will then be referred to the research team, which will provide them with detailed information about the study and obtain their informed consent. Additional recruitment strategies may also be used, such as posting notices in clinical settings or disseminating information through professional networks, to optimize recruitment.

Recruitment of healthcare professionals:

A convenience sample of approximately 12 healthcare professionals will be recruited, including endocrinologists, residents, clinical nurses, and nurse practitioners. All may be involved directly or indirectly in the implementation of the patient education program. Recruitment will be conducted in the clinical settings partnering with the study, on a voluntary basis. Professionals will be informed of the project objectives and invited to participate in the various activities according to their role. Should a professional leave the study during its course (e.g., relocation, sick leave, or maternity leave), replacements with similar characteristics may be recruited to ensure project continuity.

Intervention: The intervention consists of a patient education program. This program, structured in four phases, is interdisciplinary and person-centered, and aims to support the development of self-care and psychosocial skills in people living with obesity. Initially, a semi-structured individual interview is conducted with a nurse or physician, previously trained in patient education, to carry out a shared educational assessment. This interview, conducted in person or via video conference, helps identify the person's needs, knowledge, and priorities. Following this exchange, a personalized educational program is co-created in the form of an educational contract. The core of the intervention is a one-day in-person patient education session, offered to groups of approximately six participants, about two weeks after the shared educational assessment. In addition to this in-person session, a follow-up virtual workshop is offered approximately two weeks later, with the same group as the in-person activity. Finally, optional workshops are also offered according to the participants' needs. The workshop content will be adjusted based on the initial educational assessment to better meet the specific needs of the participants. The workshops have been developed using the current knowledge of the interdisciplinary team and may be adapted to data collected throughout the project. Finally, 2 to 4 weeks after the end of the educational workshops, a semi-structured individual interview will be conducted by a nurse or physician. This brief interview, approximately 15 minutes long, will be conducted in person or by telephone to summarize the skills developed and any other educational needs.

Data Collection: Quantitative data will be collected using self-reported questionnaires administered on the secure REDCap platform. Qualitative data from focus groups will be collected in person or via videoconference, recorded, transcribed verbatim, anonymized, and kept confidential in accordance with applicable ethical requirements.

At baseline (M0), sociodemographic and clinical data will be collected from patients. Information regarding current treatments, including medication, will also be self-reported. Participants will also complete questionnaires related to the variables under study. In addition, sociodemographic data will be collected from healthcare professionals participating in the study.

Data collected within the framework of the patient education program: The shared educational assessment will be based on qualitative data collected from participants by the nurse or physician through semi-structured individual interviews lasting a maximum of 60 minutes. Field notes will be taken by members of the research team during in-person activities to descriptively document the workshops, interactions, and key elements related to the participants' experience. Two to four weeks after the end of the educational workshops, a semi-structured individual interview will be conducted by a nurse or physician to summarize the skills developed and any other educational needs.

Statistical analyses:

Descriptive analyses will first be conducted to characterize the sample and the feasibility indicators. Continuous variables will be presented as means and standard deviations, and categorical variables as frequencies and percentages. The internal consistency of the questionnaires will be assessed using Cronbach's alpha coefficients for each of the scales and subscales used. To examine the exploratory effects of the program over time, generalized linear mixed models will be used to analyze the evolution of the measured variables (quality of life, self-efficacy, use of health resources) at the different measurement points (T0, 3, 6, 9, and 12 months).

The qualitative data recorded during the interviews and/or focus groups will be transcribed and then analyzed using a semantic thematic approach. This analysis will aim to identify, describe, and interpret themes related to program acceptability, participant satisfaction, beliefs, perceived usefulness, and the facilitators and barriers to implementing patient education in a clinical setting. The analysis will be conducted inductively and/or deductively, drawing on frameworks from implementation science. Verbatim transcripts will be systematically coded and then grouped into themes and sub-themes, allowing for a thorough understanding of the experiences of both participants and professionals.

• Quality of life in patients [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Self-efficacy in patients [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Patient participant-reported use of healthcare resources [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Number of patient participants recruited [Срок оценки: At baseline (M0)]
• Patient participation rates in the intervention [Срок оценки: Month 3 and 4]
• Patients retention rate [Срок оценки: 3, 6, 9, and 12 months]
• Questionnaire completion rate [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Work engagement in healthcare professionals [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Resilience in healthcare professionals [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]
• Satisfaction with professional life in healtcare professionals [Срок оценки: at baseline (M0), 3, 6, 9, and 12 months]