Recruiting

Observational Study

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT07668661

Conditions

Obesity (BMI>30)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Therapeutic patient education

Study Details

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)

Study ID

NCT07668661

Start date

Oct 30, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Patient participants

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.

experimental: Health care professional participants

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

Interventions

Therapeutic patient education

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 outcome measure

  • Acceptability (quantitative evaluation) [ Time Frame: Month 6, 9, and 12 after the intevention ]
  • Acceptability (qualitative assessment) [ Time Frame: Month 1 and month 12 after participant recruitment ]

Central Contacts and Locations

Central contacts

Locations

CHU de Quebec-Universite Laval

Recruiting

Québec, Quebec, Canada, G1V4G2

Contacts

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Nov 3, 2026

Last verified

Nov, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.