ObesityPilot Be-ReadyNCT07201870
Digital Preparation for Bariatric Surgery: Feasability Pilot Trial
A study testing Acces to Precare online platform in people with Obesity and Bariatric Surgery Patients, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Patients, Online Education
- What is being tested?
- Acces to Precare online platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Be part of the same household as someone already involved in this research project
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
IUCPQ
Québec, Quebec, G1V4G5
Sylvain Iceta, Md, PhD, +1 (418) 656-8711 ext. 4565, equipe.iceta@criucpq.ulaval.ca
About this study
Official title: A Pilot Feasibility Study of the Implementation, Usability, Acceptability and Effectiveness of an Online Bariatric Surgery Preparation Platform
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.
Read more
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:
- The Precare platform will exhibit high usability and acceptability.
- 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
- Being tested
- Acces to Precare online platform
- Keywords
- obesity, bariatric surgery, preparation, education platform
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acces to Precare online platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Acces to Precare online platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: at 3 and 6 months
Secondary outcomes (41)
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)
Measured: At baseline, 3 months and 6 months
Motivation to attempt metabolic and bariatric surgery
Survey on factors influencing patients' mottivation to undergo bariatric surgery
Measured: At baseline
Physical and psychological comorbidities
Number of current associated comorbidities to patient
Measured: 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
Measured: At baseline
Age of first weight gain
Age of participants when they first gained weight
Measured: At baseline
Weight Loss Attempts
Description of past weight loss attempts as reported by participant
Measured: At Baseline
Adherence to weight loss attempts
Duration of adherence to the various approaches of weight loss tried by participants
Measured: At baseline
Minimal weight
Minimum weight reached by the participant since adulthood
Measured: At baseline
Maximum weight
Maximum weight reached by the participant since adulthood
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Through study completion, an average of 2 year
Recrutement time
Assessment of the time needed to recruit the current study population
Measured: Through study completion, an average of 2 year
Time before first connection
Assessment of the time between logging sent and the first connection
Measured: Through study completion, an average of 2 year
Retention rate
Assessement of the pourcentage of participants who finish every steps of the study
Measured: Through study completion, an average of 2 year
missing and incongruent data
Percentage of missing and incongruent data
Measured: 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)
Measured: Through study completion, an average of 2 year
Response time per questionnaire
The participant's time to answer each questionnaire
Measured: Through study completion, an average of 2 year
Questionnaires reliability index
the congruence of questionnaires reliability index with the literature
Measured: Through study completion, an average of 2 year
website performance indicators
Assessment of the time to request and compute website performance indicators
Measured: Through study completion, an average of 2 year
Participant's learner profile.
The percentage of users classified in a learner profile.
Measured: Through study completion, an average of 2 year
Active User Rate
Percentage of registered users who are actively using the platform
Measured: At 3 and 6 months
Session duration
Average amount of time users spend on the platform per session
Measured: At 3 and 6 months
Views per session
Number of pages views per session
Measured: At 3 and 6 months
Login frequency
Participant's login frequency
Measured: At 3 and 6 months
Completion rates
Completion rate for each module of the platform PreCare
Measured: At 3 and 6 months
Bounce rate
Percentage of visitors who navigate away from the site after viewing only one page
Measured: At 3 and 6 months
Participants' Pathways
Assessment of the pathways followed by users (individual and cluster analysis), viewing and download rates
Measured: At 3 and 6 months
Content revisit rate
Number of time users come back to a page
Measured: At 3 and 6 months
Platform uptime
Tracking of the PreCare platform's uptime; time the platform has been operationnal during the study
Measured: 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
Measured: At 3 and 6 months
Platform's error rates
Tracking the PreCare platform's error rates; number of error occuring
Measured: At 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvain Iceta, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201870
- Sponsor's protocol ID
- 2025-4306
- Acronym
- Pilot Be-Ready
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of the Implementation, Usability, Acceptability and Effectiveness of an Online Bariatric Surgery Preparation Platform
- ClinicalTrials.gov ID
- NCT07201870
- Acronym / sponsor ID
- Pilot Be-Ready / 2025-4306
- Conditions
- Obesity, Bariatric Surgery Patients, Online Education, eHealth Literacy, Online-Intervention, Usability Satisfaction
- Keywords
- obesity, bariatric surgery, preparation, education platform
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The Precare platform will exhibit high usability and acceptability.
- Testing the Precare platform in real clinical settings is viable and will yield promising results for improving patient readiness for Metabolic and Bariatric Surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Acces to Precare online platformParticipants 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. |
| Arm 3: active arm with a full assessment | Experimental | Other: Acces to Precare online platformParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Be part of the same household as someone already involved in this research project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acces to Precare online platformPrecare 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. | Other | Arm 2: active arm with a short assessment, Arm 3: active arm with a full assessment |
Primary outcome
Self-perceived barriers to metabolic and bariatric surgery
Time frame: At baseline
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.
eHeals Literacy Scale
Time frame: At baseline
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.
Index of Learning Styles
Time frame: At baseline
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
University of Rhode Island Change Assessment Scale (URICA)
Time frame: At baseline, 3 months and 6 months
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.
Home-made survey
Time frame: At baseline, 3 months and 6 months
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)
System Usability Scale score(SUS)
Time frame: at 3 and 6 months
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)
41 secondary outcomes
Mental Health Continuum Short Form
Time frame: At baseline, 3 months and 6 months
Motivation to attempt metabolic and bariatric surgery
Time frame: At baseline
Physical and psychological comorbidities
Time frame: At baseline
Body Mass Index in kg.m-2
Time frame: At baseline
Age of first weight gain
Time frame: At baseline
Weight Loss Attempts
Time frame: At Baseline
Adherence to weight loss attempts
Time frame: At baseline
Minimal weight
Time frame: At baseline
Maximum weight
Time frame: At baseline
Binge Eating Scale score
Time frame: At baseline, 3 months and 6 months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: At baseline, 3 months and 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline, 3 months and 6 months
Canadian Food Intake Screener
Time frame: At baseline, 3 months and 6 months
Canadian Eating Practices Screener
Time frame: At baseline, 3 months and 6 months
Malnutrition Screening Tool
Time frame: At baseline, 3 months and 6 months
Global Physical Activity Questionnaire
Time frame: At baseline, 3 months and 6 months
Multidimensional Body Self Relations Questionnaire-Appearance Scales
Time frame: At baseline, 3 months and 6 months
Multidimensional Scale of Perceived Social Support
Time frame: At baseline, 3 months and 6 months
World Health Organization Quality of Life- BREF
Time frame: Art baseline, 3 mopnths and 6 months
Patient Empowerment Strategies Questionnaire
Time frame: At baseline, 3 months and 6 months
Recruitment rate
Time frame: Through study completion, an average of 2 year
Recrutement time
Time frame: Through study completion, an average of 2 year
Time before first connection
Time frame: Through study completion, an average of 2 year
Retention rate
Time frame: Through study completion, an average of 2 year
missing and incongruent data
Time frame: Through study completion, an average of 2 year
Time to complete the initial assessment
Time frame: Through study completion, an average of 2 year
Response time per questionnaire
Time frame: Through study completion, an average of 2 year
Questionnaires reliability index
Time frame: Through study completion, an average of 2 year
website performance indicators
Time frame: Through study completion, an average of 2 year
Participant's learner profile.
Time frame: Through study completion, an average of 2 year
Active User Rate
Time frame: At 3 and 6 months
Session duration
Time frame: At 3 and 6 months
Views per session
Time frame: At 3 and 6 months
Login frequency
Time frame: At 3 and 6 months
Completion rates
Time frame: At 3 and 6 months
Bounce rate
Time frame: At 3 and 6 months
Participants' Pathways
Time frame: At 3 and 6 months
Content revisit rate
Time frame: At 3 and 6 months
Platform uptime
Time frame: At 3 and 6 months
Platform load times
Time frame: At 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acces to Precare online platform in people with Obesity and Bariatric Surgery Patients, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Iceta, MD, PhD (+1 (418) 656-8711 ext. 4565, equipe.iceta@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-perceived barriers to metabolic and bariatric surgery (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.