Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07668661

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity (BMI>30)

Full registry criteria

Inclusion Criteria: * 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 * having access to the Internet Exclusion Criteria: * inability to provide informed consent or to respond to questionnaires.

Treatments and study arms

Therapeutic patient education

Behavioral

The 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.

Primary outcomes

Acceptability (quantitative evaluation)Month 6, 9, and 12 after the intevention

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)Month 1 and month 12 after participant recruitment

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

CHU de Quebec-Universite Laval🇨🇦 Québec, Quebec, Canada
Laetitia Michou, MD PhDContact