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

NCT07668661 | Not Yet Recruiting

• 1 other identifier: 2027-8689
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity (BMI>30)

Keywords

Obesity; Therapeutic patient education; type 2 diabetes; Metabolic disorders; empowerment; self-care skills; psycho-social skills

Outcome Measures

Primary Outcomes (2)

• 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

  Month 6, 9, and 12 after the intevention

• 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.

  Month 1 and month 12 after participant recruitment

Secondary Outcomes (10)

• Quality of life in patients

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

• Self-efficacy in patients

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

• Patient participant-reported use of healthcare resources

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

• Number of patient participants recruited

  At baseline (M0)

• Patient participation rates in the intervention

  Month 3 and 4

Study Arms (2)

Patient participants

EXPERIMENTAL

Between month 0 to month 3, participants will received usual care. Just after month 3 questionnaires completion, participants will receive the intervention of therapeutic patient education, with a follow-up up to nine months after the 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.

Behavioral: Therapeutic patient education

Health care professional participants

EXPERIMENTAL

12 healthcare professionals will recruited within the endrocrinology team, participating to the intervention as a healthcare professional or not.

Behavioral: Therapeutic patient education

Interventions

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.

Health care professional participants; Patient participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to provide informed consent or to respond to questionnaires.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Quebec-Universite Laval

Québec, Quebec, G1V4G2, Canada

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Metabolic Diseases; Empowerment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Laetitia Michou, MD PhD

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia Michou, MD PhD

CONTACT

+14185254444; laetitia.michou@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/post intervention evaluation

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CA (1)