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

OBEDIAM: a Pilot Study of Therapeutic Patient Education in Adults Living With Obesity, Diabetes, and Metabolic Disorders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity (BMI>30)
• Intervention / Treatment: Behavioral: Therapeutic patient education

Detailed Description

Rationale:

Obesity is associated with several physical and psychological complications that can affect quality of life. Managing obesity requires an interdisciplinary, individualized, and person-centered approach. People living with obesity often have to make complex decisions related to diet, physical activity, sleep, and mental health. Many report not feeling sufficiently supported or equipped to manage their health on a daily basis, particularly due to weight stigma and barriers to accessing care. Therapeutic patient education (TPE) aims to support people living with a chronic illness in developing self-management skills and making informed decisions. In the context of obesity, structured educational interventions appear to promote the adoption of healthy behaviors and support an approach not exclusively focused on weight. This project aims to co-develop, with citizen partners and healthcare professionals, a therapeutic patient education (TPE) program for the population living with obesity, and then to evaluate its acceptability.

Hypothesis:

A patient education program co-developed with citizen partners and healthcare professionals is acceptable for people living with obesity, particularly in terms of accessibility and feasibility.

Main Objective:

The objective of this pilot study is to co-develop a patient education program for people living with obesity, adapted to the Quebec context, and then to assess its acceptability.

More specifically, the study aims to:

• Co-develop the content and modalities of the program in collaboration with citizen partners and healthcare professionals;
• Explore participants' perceptions of the acceptability and feasibility of such a program;
• Document the facilitators and barriers to its implementation in the Quebec context with patients and healthcare professionals.

Secondary Objectives

• Explore the effects of a patient education program for people living with obesity, using a pre/post-intervention comparison of patient-reported health data, including quality of life, self-efficacy, and use of healthcare resources.
• Evaluate the feasibility of the study by documenting participant recruitment and retention over a 12-month period, as well as their participation in program activities.
• Describe the engagement of healthcare professionals involved in the program's implementation.

Study Design:

The first phase aims to co-construct the patient education program adapted to the Quebec context. It is based on a participatory qualitative approach involving patient partners and healthcare professionals.

The second phase focuses on the implementation and evaluation of the patient education program's acceptability. It consists of a pilot study using a mixed-methods approach, including a pre/post-intervention quantitative component to explore the program's effects on quality of life, self-efficacy, and healthcare resource utilization, and a qualitative component to document the program's acceptability, the study's feasibility, and the facilitators and barriers to its implementation.

Research Procedures:

Study Population: The study population will consist of adults living with obesity receiving care in a Quebec healthcare setting.

Patient Recruitment: A convenience sample of approximately 30 patients will be recruited for the pilot phase of the study. Recruitment will take place in clinical settings specializing in obesity, particularly within the endocrinology and metabolic medicine clinics of the CHU de Québec. Healthcare professionals involved in these settings will identify potentially eligible patients and briefly present the project to them. Interested individuals will then be referred to the research team, which will provide them with detailed information about the study and obtain their informed consent. Additional recruitment strategies may also be used, such as posting notices in clinical settings or disseminating information through professional networks, to optimize recruitment.

Recruitment of healthcare professionals:

A convenience sample of approximately 12 healthcare professionals will be recruited, including endocrinologists, residents, clinical nurses, and nurse practitioners. All may be involved directly or indirectly in the implementation of the patient education program. Recruitment will be conducted in the clinical settings partnering with the study, on a voluntary basis. Professionals will be informed of the project objectives and invited to participate in the various activities according to their role. Should a professional leave the study during its course (e.g., relocation, sick leave, or maternity leave), replacements with similar characteristics may be recruited to ensure project continuity.

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. Initially, a semi-structured individual interview is conducted with a nurse or physician, previously trained in patient education, to carry out a shared educational assessment. This interview, conducted in person or via video conference, helps identify the person's needs, knowledge, and priorities. Following this exchange, a personalized educational program is co-created in the form of an educational contract. 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. In addition to this in-person session, a follow-up virtual workshop is offered approximately two weeks later, with the same group as the in-person activity. 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. The workshops have been developed using the current knowledge of the interdisciplinary team and may be adapted to data collected throughout the project. 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. This brief interview, approximately 15 minutes long, will be conducted in person or by telephone to summarize the skills developed and any other educational needs.

Data Collection: Quantitative data will be collected using self-reported questionnaires administered on the secure REDCap platform. Qualitative data from focus groups will be collected in person or via videoconference, recorded, transcribed verbatim, anonymized, and kept confidential in accordance with applicable ethical requirements.

At baseline (M0), sociodemographic and clinical data will be collected from patients. Information regarding current treatments, including medication, will also be self-reported. Participants will also complete questionnaires related to the variables under study. In addition, sociodemographic data will be collected from healthcare professionals participating in the study.

Data collected within the framework of the patient education program: The shared educational assessment will be based on qualitative data collected from participants by the nurse or physician through semi-structured individual interviews lasting a maximum of 60 minutes. Field notes will be taken by members of the research team during in-person activities to descriptively document the workshops, interactions, and key elements related to the participants' experience. Two to four weeks after the end of the educational workshops, a semi-structured individual interview will be conducted by a nurse or physician to summarize the skills developed and any other educational needs.

Statistical analyses:

Descriptive analyses will first be conducted to characterize the sample and the feasibility indicators. Continuous variables will be presented as means and standard deviations, and categorical variables as frequencies and percentages. The internal consistency of the questionnaires will be assessed using Cronbach's alpha coefficients for each of the scales and subscales used. To examine the exploratory effects of the program over time, generalized linear mixed models will be used to analyze the evolution of the measured variables (quality of life, self-efficacy, use of health resources) at the different measurement points (T0, 3, 6, 9, and 12 months).

The qualitative data recorded during the interviews and/or focus groups will be transcribed and then analyzed using a semantic thematic approach. This analysis will aim to identify, describe, and interpret themes related to program acceptability, participant satisfaction, beliefs, perceived usefulness, and the facilitators and barriers to implementing patient education in a clinical setting. The analysis will be conducted inductively and/or deductively, drawing on frameworks from implementation science. Verbatim transcripts will be systematically coded and then grouped into themes and sub-themes, allowing for a thorough understanding of the experiences of both participants and professionals.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laetitia Michou, MD PhD; Phone Number: 48383 +14185254444; Email: laetitia.michou@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G2
      • CHU de Quebec-Universite Laval
      • Contact: Laetitia Michou, MD PhD; Phone Number: 48383 +14185254444; Email: laetitia.michou@crchudequebec.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Therapeutic patient education; The intervention consists of a patient education program. This program, structured in four phases.; Initially, a semi-structured individual interview is conducted with a nurse or physician to carry out a shared educational assessment.; Then a personalized educational program is co-created in the form of an educational contract.; 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.; 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.
Experimental: Health care professional participants; 12 healthcare professionals will recruited within the endrocrinology team, participating to the intervention as a healthcare professional or not.	Behavioral: Therapeutic patient education; The intervention consists of a patient education program. This program, structured in four phases.; Initially, a semi-structured individual interview is conducted with a nurse or physician to carry out a shared educational assessment.; Then a personalized educational program is co-created in the form of an educational contract.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at baseline (M0), 3, 6, 9, and 12 months
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).	at baseline (M0), 3, 6, 9, and 12 months
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.	at baseline (M0), 3, 6, 9, and 12 months
Number of patient participants recruited	Percentage of patients recruited/ all patients approached for the study	At baseline (M0)
Patient participation rates in the intervention	Percentage of participation of patients for each step of the intervention	Month 3 and 4
Patients retention rate	Percentage of patient participants still participating to the project	3, 6, 9, and 12 months
Questionnaire completion rate	Percentage of participating patient completing the study questionnaires at different time of the study	at baseline (M0), 3, 6, 9, and 12 months
Work engagement in healthcare professionals	The Utrecht Work Engagement Questionnaire will be used in this study in its 17-item version. The response format is based on a 7-point Likert scale (0 = never, 6 = always). Total score range from 0 (very low) to 6 (very high).	at baseline (M0), 3, 6, 9, and 12 months
Resilience in healthcare professionals	Resilience will be measured using the Brief Resilience Scale. This scale assesses an individual's ability to bounce back or recover from stressful situations. The questionnaire comprises six items, rated on a 5-point Likert-type scale from 1 ("strongly disagree") to 5 ("strongly agree"). Three items are worded negatively (items 2, 4, and 6) and are reversed when calculating the score. The overall score is obtained by averaging the six items, with a higher score indicating greater resilience.	at baseline (M0), 3, 6, 9, and 12 months
Satisfaction with professional life in healtcare professionals	Job satisfaction will be measured using an adapted version of the Satisfaction With Life Scale. This scale assesses an individual's overall judgment of their life, specifically in the professional sphere. The scale comprises five items, rated on a 7-point Likert-type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The total score is obtained by summing the responses to the five items, with a higher score indicating a greater level of job satisfaction.	at baseline (M0), 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Laetitia Michou, MD PhD, CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; type 2 diabetes; empowerment; Metabolic disorders; Therapeutic patient education; self-care skills; psycho-social skills
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Social Behavior; Obesity; Diabetes Mellitus, Type 2; Metabolic Diseases; Empowerment
• Other Study ID Numbers: 2027-8689

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No