An interventional study of Therapeutic patient education in Obesity (BMI>30), sponsored by CHU de Quebec-Universite Laval. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Other
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.
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:
Secondary Objectives
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 42 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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. 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.
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
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
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
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
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
Number of patient participants recruited
Percentage of patients recruited/ all patients approached for the study
Time frame: At baseline (M0)
Patient participation rates in the intervention
Percentage of participation of patients for each step of the intervention
Time frame: Month 3 and 4
Patients retention rate
Percentage of patient participants still participating to the project
Time frame: 3, 6, 9, and 12 months
Questionnaire completion rate
Percentage of participating patient completing the study questionnaires at different time of the study
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: at baseline (M0), 3, 6, 9, and 12 months
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
Start moved twice since we started tracking on Sep 25, 2026: Jul 2026 → Oct 2026, last on Nov 3, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2027 → Oct 2027, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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