An interventional study of Acces to Precare online platform in Obesity, Bariatric Surgery Patients and Online Education, sponsored by Laval University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Laval University · Not applicable, Interventional, and Supportive care
Metabolic and bariatric surgery (MBS) is in increasing demand due to the growing prevalence of severe obesity and the cumulating evidence of long-term benefits on weight loss, cardiometabolic and functional health outcomes, and quality of life for individuals living with severe obesity. The time spent on the waiting list for an MBS follow the same trend with an estimated waiting time of more than 18 months and rising. The lack of resources and multidisciplinary capabilities among MBS centers impacts the quality of care and outcomes, which greatly contributes to delayed surgery. In 2023, 31% of patients who had an initial appointment with the MBS nurse at the Quebec Heart and Lung Institute - Laval University(IUCPQ) did not proceed with the surgery due to fear, uncertainty, or timing issues. Additionally, 49% reported that their concerns (e.g., financial, home support) were not addressed before MBS. These data highlight the urgent need to implement strategies to optimize wait time and ensure that MBS preparation is tailored to patients' expectations. Telehealth has significantly impacted surgical preparation, including for MBS, by enhancing accessibility, reducing dropout rates, and maintaining clinical outcomes that are comparable to traditional in-person visits but it requires real-time multidisciplinary execution, limiting the applicability for MBS waiting list patients. An interesting complement to telehealth intervention is online education platforms which offer digital flexibility, a significant advantage over in-person session.
To date, most MBS online resources are fee-based or driven by commercial interests and lack of clinical evidence, which raises concerns about their efficacy and safety for users who are seeking reliable support during their MBS journey.
A free online education platform could optimize the time spent on the MBS waiting list by increasing patients' readiness for MBS, furnishing invaluable insights into the patient journey to MBS, and empowering individuals undergoing MBS. The IUCPQ is in the process of working on the care trajectory of patients with obesity. The Healthcare Direction and the Bariatric Surgery Clinic decided to use a platform called Precare. This platform offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services. The present research focuses on the pilot testing the implementation and effectiveness of the PreCare solution for patients awaiting bariatric surgery at the IUCPQ.
The objectives of the research proposal are: 1) To assess the usability and acceptability of the Precare platform using a mixed design methodology; 2) To evaluate the logistical feasibility of using the platform in a clinical setting; 3) To determine whether extensive self-questionnaire assessments may impact the use of the Precare platform; 4) To explore barriers and facilitators to enhance patient engagement and knowledge retention; and 5) To derive estimates variables related to gender, ethnicity, cultural background, learners and psychological profiles for future phases.
Our hypotheses are:
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 1,050 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Participants will follow the standard protocols of preparation for a bariatric surgery and remain on the waiting list without access to the educational platform (Precare). Participants will have to fulfill the participant's description module and the readiness assessment. After the 6-month assessment, the patient will be providing a full access to Precare and will follow the same assessment process as arm 3 (i.e., Precare usability module, and the secondary clinical assessment module).
Participants randomized to the active arm with a short assessment (arm 2) will be provided with 6-month of full access to the educational platform Precare and will have to fulfill the participant's description module and the readiness assessment (same as arm 1), as well as the Precare usability module.
Other: Acces to Precare online platform
Participants randomized to the active arm with a full assessment (arm 3) will be provided with 6-month of full access to the educational platform Precare after having fulfilled a REDCap module, including the participant's description module, the readiness assessment, the Precare usability module, and the secondary clinical assessment module.
Other: Acces to Precare online platform
Precare is an online educational platform for patients on the waiting list for bariatric surgery. Precare offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services.
Self-perceived barriers to metabolic and bariatric surgery
Short questionnaire to assess the barriers to the decision for bariatric surgery perceived by patients based on Luck-Sikorski C, Jung F, Dietrich A, Stroh C, Riedel-Heller SG. Perceived Barriers in the Decision for Bariatric and Metabolic Surgery: Results from a Representative Study in Germany. Obes Surg. 2019 Dec;29(12):3928-3936. doi: 10.1007/s11695-019-04082-1. PMID: 31301032.
Time frame: At baseline
eHeals Literacy Scale
Survey to measure Participants' feelings about their use of the Internet as a tool for obtaining health-related information. We will use the validated french version of the eHeals scale, a 10-item questionnaire. Question's response is measured with a 5 point likert scale with response options either going from 'strongle disagree' to 'strogly agree', 'not at all; usefull' to 'very usefull' or ' Not at all important' to 'Very important'. Higher scores represent higher sefl-perceive eHeals literacy.
Time frame: At baseline
Index of Learning Styles
To assess of the learner profile of the patient (44 items) Adapted from the Index of Learning Styles Questionnaire by Barbara A. Solomon \& Richard M. Felder University of North Carolina Raleigh, NC 27695
Time frame: At baseline
University of Rhode Island Change Assessment Scale (URICA)
32-item scale based on Prochaska and DiClemente's transtheoretical behaviour change model to assess the readiness of the patient to bariatric surgery. Each question is measured on a 5-point Likert scale with response options ranging from "strongly disagree"(1 point) to "strongly agree"(5 points). Questions are divided into four subscales of 8 items each: precontemplation, contemplation, action and maintenance. Each subscale score from 1 to 40. The readiness to bariatric surgery score is calculated by adding the scores from the Contemplation, Action and Maintenance subscales and subtracting from that sum the Precontemplation subscale score. The total score ranges from 1 to 160, with higher scores indicating better readiness.
Time frame: At baseline, 3 months and 6 months
Home-made survey
To assess readiness of the patient to bariatric surgery. Questionnaire based on the current questionnaire sent to participants when they attempt psychiatric assessment for metabolic and bariatric surgery at the Quebec Heart and Lung Institute - Laval University(IUCPQ)
Time frame: At baseline, 3 months and 6 months
System Usability Scale score(SUS)
To asses the usability of the platform Precare based. SUS is a 10-item validated questionnaire for assessing system usability, including software, websites, and applications. Each item is rated on a 5 points Likert scale ranging from 'Strongly disagree'(1) to 'strongly agree'(5). A higher score represent a higher usability of the platform. (only for arm 2 and arm 3)
Time frame: at 3 and 6 months
Mental Health Continuum Short Form
14-item questionnaire to assess overall psychopathology. Each question is measured on a 6-point Likert scale with response options ranging from "Never"(0 point) to "Everyday"(5 points). Total score ranges from 0 to 70, with a higher score representing better mental well-being. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Motivation to attempt metabolic and bariatric surgery
Survey on factors influencing patients' mottivation to undergo bariatric surgery
Time frame: At baseline
Physical and psychological comorbidities
Number of current associated comorbidities to patient
Time frame: At baseline
Body Mass Index in kg.m-2
Anthropometric markers: weight and height will be combined to report the body mass index (BMI) in kg/m\^2
Time frame: At baseline
Age of first weight gain
Age of participants when they first gained weight
Time frame: At baseline
Weight Loss Attempts
Description of past weight loss attempts as reported by participant
Time frame: At Baseline
Adherence to weight loss attempts
Duration of adherence to the various approaches of weight loss tried by participants
Time frame: At baseline
Minimal weight
Minimum weight reached by the participant since adulthood
Time frame: At baseline
Maximum weight
Maximum weight reached by the participant since adulthood
Time frame: At baseline
Binge Eating Scale score
To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder. The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to say if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
The mYFAS 2.0 was designed to assess food addiction using a shorter version than the YFAS 2.0.It assesses the symptoms of food addiction and the resulting distress and impaired functioning. The higher the level of symptoms, the more severe the food addiction. Impaired functioning and distress are scored from 0 to 2. Symptoms are scored from 0 to 11. If the functioning and distress score is 1 and above, the food addiction may be mild (2-3 symptoms), moderate (4-5 symptoms), or severe (6+ symptoms). (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Hospital Anxiety and Depression Scale (HADS)
This self-administered questionnaire assesses depressive symptoms using seven items (ÉHAD-D) and anxiety symptoms using another seven items (ÉHAD-A), for a total of 14 items. Each question is scored from 0 to 3. Higher scores indicate higher level of anxiety and depression. A total score between 0 and 7 reflects a normal level of anxiety and depression, a score of 8 to 10 indicates a borderline level and a score of 11 and above indicates a high level of anxiety and depression. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Canadian Food Intake Screener
To assess the participant's degree of adherence to the Canada's food guide (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Canadian Eating Practices Screener
To assess the participant's degree of adherence to the Canada's food guide (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Malnutrition Screening Tool
To assess participant's risk of malnutrition scored from 0 to 7. A score of 2 or more means the participant is at risk for malnutrition. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Global Physical Activity Questionnaire
Questionnaire from the World Health Organization to assess physical activity participation of the patient (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Multidimensional Body Self Relations Questionnaire-Appearance Scales
34-item questionnaire to assess aspects of body image. Questions are divided into five subscales: Appearance Evaluation, Appearance Orientation, Body Area Satisfaction, Overweight Preoccupation and Self-classified Weight. Each question is measured with 5-point Likert scales. The mean of each subscale is calculated. Higher scores generally indicate more positive body image and appearance satisfaction (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Multidimensional Scale of Perceived Social Support
12-Item questionnaire to assess the social support of patients. Each question is measured on a 7-point Likert scale with response options ranging from " very strongly disagree"(1 point) to "very strongly agree"(7 points). Questions are divided into three subscales of four items each: Significant others, Friends and Family. Each subscale score ranges from 4 to 28. A higher score indicates a higher perceived support. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
World Health Organization Quality of Life- BREF
26-item questionnaire to assess the quality of life of the patient. Each question is measured on 5-point Likert scales. Total score ranges from 0 to 100, with higher score associated to better quality of life. (Only for arm 3)
Time frame: Art baseline, 3 mopnths and 6 months
Patient Empowerment Strategies Questionnaire
15-item questionnaire to assess the patient empowerment. Each question is measured on a 4-point Likert scale with response options ranging from "totally agree"(4 point) to "totally disagree"(1 points). Score ranges from 15 to 54. Higher scores indicate greater patient empowerment. (Only for arm 3)
Time frame: At baseline, 3 months and 6 months
Recruitment rate
Assessed by calculating the ratio of participants recruited for the current study / number of participants invited to participate in the present study.
Time frame: Through study completion, an average of 2 year
Recrutement time
Assessment of the time needed to recruit the current study population
Time frame: Through study completion, an average of 2 year
Time before first connection
Assessment of the time between logging sent and the first connection
Time frame: Through study completion, an average of 2 year
Retention rate
Assessement of the pourcentage of participants who finish every steps of the study
Time frame: Through study completion, an average of 2 year
missing and incongruent data
Percentage of missing and incongruent data
Time frame: Through study completion, an average of 2 year
Time to complete the initial assessment
Assessment of the mean time to complete the initial assessment (overall and per questionnaires)
Time frame: Through study completion, an average of 2 year
Response time per questionnaire
The participant's time to answer each questionnaire
Time frame: Through study completion, an average of 2 year
Questionnaires reliability index
the congruence of questionnaires reliability index with the literature
Time frame: Through study completion, an average of 2 year
website performance indicators
Assessment of the time to request and compute website performance indicators
Time frame: Through study completion, an average of 2 year
Participant's learner profile.
The percentage of users classified in a learner profile.
Time frame: Through study completion, an average of 2 year
Active User Rate
Percentage of registered users who are actively using the platform
Time frame: At 3 and 6 months
Session duration
Average amount of time users spend on the platform per session
Time frame: At 3 and 6 months
Views per session
Number of pages views per session
Time frame: At 3 and 6 months
Login frequency
Participant's login frequency
Time frame: At 3 and 6 months
Completion rates
Completion rate for each module of the platform PreCare
Time frame: At 3 and 6 months
Bounce rate
Percentage of visitors who navigate away from the site after viewing only one page
Time frame: At 3 and 6 months
Participants' Pathways
Assessment of the pathways followed by users (individual and cluster analysis), viewing and download rates
Time frame: At 3 and 6 months
Content revisit rate
Number of time users come back to a page
Time frame: At 3 and 6 months
Platform uptime
Tracking of the PreCare platform's uptime; time the platform has been operationnal during the study
Time frame: At 3 and 6 months
Platform load times
Tracking the PreCare platform's load time ; time it take the platform to display the requested page
Time frame: At 3 and 6 months
Platform's error rates
Tracking the PreCare platform's error rates; number of error occuring
Time frame: At 3 and 6 months
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