EAT SMART Teen Study

The study is a two-phased double-blind, balanced, parallel-group, Randomized Controlled Trial (RCT), with the overall goal to assess a 12-week MBI for adolescents living with obesity. The study will be conducted at the Children's Hospital of Eastern Ontario (CHEO) and will include a pilot phase (Phase 1) followed by a randomized controlled trial (Phase 2). The study will evaluate the feasibility and efficacy of the MB-EAT intervention delivered through the Dawn DTx platform, using Dawn-Epiq, a Class II investigational device. The intervention will be delivered in a scalable app-based modality to youth aged 12-17 years living with obesity, with the objective of assessing its effects on eating behaviour, mental health, and weight regulation.

Participants:

Patients waitlisted for treatment at CHEO's Centre for Healthy and Active Living will be invited to take part in this study.

For phase 1, a small pilot study will be conducted to assess the usability, acceptance, and adherence to an audio-recorded mindfulness app-based MB-EAT Teen intervention. Results of the pilot will inform us as to whether any modifications are required to the app instructions, the intervention, or identify ways to increase adherence. Phase 2 will only start once any issues from phase 1 have been resolved.

Phase 2 will be a RCT with two arms. The experimental group will receive the MB-EAT Teen program, and the control group will receive the psychoeducation EAT SMART Teen program, simulating community accessible psychoeducational resources.

The overall study plans to enrol 170 participants across both phases: The estimated sample size for phase 1 is 10 participants and a total of 160 for phase 2. Participants will be randomly assigned to either group. The research staff, and patients/families will be blinded to study group assignment. Some study staff will be unblinded and will serve as coaches who will follow up with participants each week to address any technical issues, to promote engagement, and to address any questions participants may have regarding module content. In the instance of an adverse event, the qualified investigator may be unblinded to the specific participant's intervention plan.

The randomization scheme will be designed and administered by the REDCap platform via an algorithm. Computer-generated random group listing will be applied using a 1:1 allocation using random blocks. This randomization method has been proven efficient and successful in trials of similar magnitude performed at participating study sites. Randomization will be stratified by age (12-14 years, and 15-17 years) to control for possible developmental differences that may influence responses to the mindful eating intervention.

The research staff, and patients/families will be blinded to study group assignment. Some study staff will be unblinded and will serve as coaches who will follow up with participants each week to address any technical issues, to promote engagement, and to address any questions participants may have regarding module content. In the instance of an adverse event, the qualified investigator may be unblinded to the specific participant's intervention plan.

Participating in this study will involve several steps over 12 weeks that include:

Baseline Assessments: Participants will be asked to complete some questionnaires, an ad-libitum food task, and computer games at CHEO and take part in a motivational interview. During this session the participants will also be shown how to access the application on a smartphone. This will take approximately 180 minutes to complete.

Intervention Phase (Weeks 1 to 12): Participants will be asked to complete the app-based program over a 12-week period. This program is aimed at teaching new information, skills, and practices that may help improve the mental well-being of the participants. These app-based activities will take about 15-20 minutes per day to complete. Participants will receive texts/emails/calls from a coach on the research team to check in on progress. The app will collect information about how many times participants have accessed the app, and whether the program is completed.

Mid-point Assessment (Week 6): Participants will be asked to complete some more questionnaires, an ad-libitum food task, and computer games at CHEO. In total, the mid-point assessment will take approximately 120 minutes to complete.

Final Assessment (Week 12): Participants will be asked to complete some more questionnaires, , an ad-libitum food task, and computer games at CHEO and may also be offered the opportunity to participate in an optional semi-structured interview about their overall experience with the program. The interview will be audio recorded and may take place virtually over MS Teams or in-person at CHEO. In total, the final assessment will take approximately 120 minutes to complete. Once the assessments are complete, a research member will call the participants to inform about which group they were part of.

Questionnaires:

Participants will be provided with a series of questionnaires via online CHEO REDCap at three points during the study: baseline, in 6 weeks, and in 12 weeks. These questionnaires will ask about the habits and mental health of the participant and will take approximately 30 minutes to complete at each timepoint. The information that is provided is for research purposes only. Some of the questions are personal. Participants can choose not to answer questions if they wish. The questionnaires will collect information we think might be influenced by the intervention.

Computer Games:

Participants will be asked to complete some computer games at three points during the study: baseline, in 6 weeks, and in 12 weeks. These computer games will measure food reinforcement. Participants will be given an ad-libitum meal during each visit.

Interviews:

Participants will be asked to participate in a 1-hour motivational interview during the baseline visit. This interview is collaborative and designed to promote motivation to engage in the intervention. After the 12-week period using the app, the participants may be asked whether they are interested in participating in an optional 1-hour exit interview over MS Teams or in-person. The purpose of this interview is to learn about their experience with the intervention and the perceived impact. The feedback of participants will help the research team in assessing the feasibility of implementing the intervention model as described.

The research team may review the medical records of the participants to complete required information to confirm their eligibility (if necessary) and to check that the information collected for the study is correct.

Quality Control and Quality Assurance:

The study will comply with the requirements of the CHEO REB. The study coordinator will be responsible for day-to-day operations and overall study management. Trial monitoring will be conducted to ensure that the rights and well-being of trial participants are protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), Declaration of Helsinki and the Tri-Council Policy Statement (2nd Edition): Ethical Conduct for Research Involving Humans (2014), and conform to Good Clinical Practices as set out by ISO 14155 Clinical investigation of medical devices for human subjects and Part 3 of the Medical Device Regulations. Monitoring of data integrity, regulatory compliance and participant safety will be performed in accordance with a separate Monitoring Plan. Monitoring will be conducted by the CHEO Research Institute. A monitor will be assigned to monitoring the trial and will be given direct access to source documents, case report forms, and other study-related essential documents to carry out monitoring for the trial.

Adverse Events Reporting and Treatment Discontinuation Any adverse or serious adverse events that occur between the time the participant begins the intervention until the time the participant completes the last follow-up survey will be captured in an Adverse Events Reporting form on REDCap. At each follow-up session, participants will be asked to report any adverse events they experienced on a REDCap survey. If participants answer "yes" to an unscheduled visit to the emergency department, primary health care provider, or mental health walk-in clinic due to a worsening in current mental health symptoms or any new mental health symptoms, they will indicate the date of the event, the reasons for the unscheduled healthcare visit, and how they were treated. The QI will document and assess the event to identify whether or not the adverse event is deemed to be linked to the app intervention. Study staff will attempt to follow up with the participant, after consulting with the QI, within 24 hours of the flagged notification in REDCap.

The QI will determine the necessary course of action and delegate the plan and actions to the study staff, such as contacting the caregiver and/or participant to gather further information, advising the participant to present to the emergency department if deemed necessary, referring the participant to appropriate community resources, or deeming the adverse event resolved or stabilized. If follow-up is required, study staff will document this in REDCap. SAEs will be reported to the CHEO Research Ethics Board according to reporting requirements, as well as to the manufacturer/regulatory contact, who will report to Health Canada. The QI will report SAEs and SADEs to Health Canada and to the manufacturer and importer within 72 hours of discovery. Extended follow-up will occur as required when the event does not resolve or stabilize, with the frequency, nature, and timing determined by the QI and follow-up planning delegated to study staff. Study staff may schedule an in-person follow-up in lieu of a telephone follow-up when deemed necessary for participant safety. All adverse events and serious adverse events will be followed until resolution, until deemed stabilized, or until participation in the study has ended.

The study will not directly assess or screen for suicidal ideation. CESD-10 scores at baseline and follow-up will be used to define severe worsening in depressive symptoms as greater than 1 standard deviation in the CESD-10 score from the previous assessment. Where severe worsening is identified and the participant has not disclosed an adverse event, this will be classified as an adverse event, and the study staff will document and report the event on REDCap and follow up with the participant. If deemed necessary, extended follow-up will be performed. If a participant directly discloses to the coach that they are acutely suicidal, they will be advised to close the mindfulness app, speak with their caregiver, and call 9-1-1 immediately or follow up immediately at their nearest emergency department or mental health walk-in clinic. If there is no response from the participant following the coach's emergency prompt response, an attempt will be made to contact the participant's caregiver using the contact numbers provided during consent/assent and stored in the Master Log. The procedures to document, report, and follow up on the adverse event will then be followed.

Participants and/or their caregiver/SDM will be informed in a timely manner of any new information, including safety information relevant to their willingness to continue participation, with communication documented through a revised REB-approved Informed Consent/assent form where applicable. Participants can withdraw from the study at any time without associated repercussions, and a list of mental health resources will be provided upon signed consent/assent. A participant will be permanently discontinued when consent is withdrawn, when the investigator believes ongoing participation poses a significant risk, could invalidate the results of the study, or involves a high risk of self-harm, or when there is loss to follow-up involving absence of all efficacy and follow-up assessments. Protocol deviations will be identified, documented, assessed, and reported by the QI or delegate according to local requirements. Major deviations involving potential impact on participant safety, rights, welfare, or data integrity will be reported to the REB as soon as possible following the event. Deviations should not be implemented without prior agreement from the QI and REB approval as required, unless necessary to eliminate an immediate hazard to trial subjects or when the change is administrative or logistical in nature.