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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCHU de Quebec-Universite Laval

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Patient participantsExperimental treatment 1 intervention
Group B: Health care professional participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Month 6, 9, and 12 after the intevention
2

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.

Time frame
Month 1 and month 12 after participant recruitment

Secondary outcomes

1

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).

Time frame
at baseline (M0), 3, 6, 9, and 12 months
2

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).

Time frame
at baseline (M0), 3, 6, 9, and 12 months
3

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.

Time frame
at baseline (M0), 3, 6, 9, and 12 months
4

Number of patient participants recruited

Percentage of patients recruited/ all patients approached for the study

Time frame
At baseline (M0)

Other outcomes

Sponsors and contacts

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