About this trial
The goal of this observational study is to learn about the acceptability and feasibility of a therapeutic patient education program in adults living with an obesity. The main question it aims to answer is:
Is the intervention of therapeutic patient education acceptable for patients living with an obesity?
Participants will answer questionnaires and participate to focus groups before and up to nine months after the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 80
living with obesity defined by a BMI ≥ 30 kg/m2 with a stage ≥ 2 according to the Edmonton Obesity Staging System (EOSS)
and at least one obesity-related comorbidity, including type 2 diabetes, steatohepatitis associated with metabolic dysfunction (MASH), polycystic ovary syndrome or osteoarthritis
speaking and understanding French
Disqualifiers
inability to provide informed consent or to respond to questionnaires.
Trial design
Parallel
Treatments tested in this trial
Therapeutic patient education
BehavioralThe intervention consists of a patient education program. This program, structured in four phases. 1. Initially, a semi-structured individual interview is conducted with a nurse or physician to carry out a shared educational assessment. 2. Then a personalized educational program is co-created in the form of an educational contract. 3. 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. A follow-up virtual workshop is offered approximately two weeks later. 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. 4. 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.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability (quantitative evaluation)
The acceptability of the therapeutic patient education program will be assessed in patient participants by the perceived value scale based 17 items and answered using a 7-point Likert scale, developed in French for patient education purposes. Minimal score 7, maximal score 119. High score, better perceived value
Acceptability (qualitative assessment)
Semi-structured group interviews (8-10 people per group) will complement the acceptability assessment in both patient and healthcare professional participants. These semi-structured focus groups, one PRE-PEP group (within one month of recruitment) and one POST-PEP group (12 months after recruitment), will be conducted with a subsample of participants (N = 8 to 10) to explore their experience of the program, their perception of its acceptability and relevance, and the perceived impact on their daily lives.
Secondary outcomes
Quality of life in patients
Quality of life will be measured using the Impact of Weight on Quality of Life - Lite (IWQOL-Lite), a 31-item obesity-specific questionnaire. Score range from 0 (worst) to 100 (best quality of life).
Self-efficacy in patients
General self-efficacy will be assessed using the General Self-Efficacy Scale, which consists of 10 items measuring overall feelings of personal competence in the face of everyday challenges. This is a self-administered questionnaire where each statement refers to a successful adaptation and implies a stable internal attribution of success. It uses a response scale of 1 to 4, where 1 means "Not at all true" and 4 means "Completely true." Score range from 10 to 40 (stronger self-efficacy).
Patient participant-reported use of healthcare resources
The use of health resources will be measured using a self-reported questionnaire adapted from the Client Service Receipt Inventory.
Number of patient participants recruited
Percentage of patients recruited/ all patients approached for the study
Sponsors and contacts
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