Digital Preparation for Bariatric Surgery: Feasability Pilot Trial

NCT07201870 | Not Yet Recruiting

• 1 other identifier: 2025-4306
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.The Precare platform will exhibit high usability and acceptability.
2. 2.Testing the Precare platform in real clinical settings is viable and will yield promising results for improving patient readiness for Metabolic and Bariatric Surgery.

Conditions

Obesity; Bariatric Surgery Patients; Online Education; eHealth Literacy; Online-Intervention; Usability Satisfaction; Implementation Strategies; Shared Decision Making

Keywords

obesity; bariatric surgery; preparation; education platform

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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.

  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)

  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)

  at 3 and 6 months

Secondary Outcomes (41)

• Mental Health Continuum Short Form

  At baseline, 3 months and 6 months

• Motivation to attempt metabolic and bariatric surgery

  At baseline

• Physical and psychological comorbidities

  At baseline

• Body Mass Index in kg.m-2

  At baseline

• Age of first weight gain

  At baseline

Study Arms (3)

Arm 1: Control arm

NO INTERVENTION

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).

Arm 2: active arm with a short assessment

EXPERIMENTAL

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

Arm 3: active arm with a full assessment

EXPERIMENTAL

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

Interventions

Acces to Precare online platform OTHER

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.

Arm 2: active arm with a short assessment; Arm 3: active arm with a full assessment

Eligibility Criteria

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

You may qualify if:

• Be on the waiting list for metabolic and bariatric surgery at IUCPQ
• not yet assessed by the local team and with an expected wait time of more than 6 months
• understand French
• Have an active email address

You may not qualify if:

• Be part of the same household as someone already involved in this research project

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sylvain Iceta, MD, PhD

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The 3 arms will be evaluated at baseline, after 3 months and after 6 months. The control group (Arm 1) will then follow a sequential study model and follow the same course ass arm 3. This will ensure equality of car for every participant.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: October 1, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CA (1)