The MB-EAT Smart Teen Study

NCT ID: NCT07130838

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-04-01

Brief Summary

This two-phase, double-blind, balanced, parallel-group randomized controlled trial evaluates the feasibility, usability, engagement, and clinical impact of an app-based adaptation of the Mindfulness-Based Eating Awareness Training (MB-EAT) program for adolescents living with obesity.

MB-EAT, has been shown to reduce binge eating episodes, improve food-related self-control, and decrease depressive symptoms in adults with obesity. The app based program promotes mindful awareness and self-regulation in response to hunger and satiety cues, without caloric restriction.

Youth aged 12-17.5 years who are waitlisted or have recently been waitlisted for treatment at the Centre for Healthy Active Living (CHAL) at the Children's Hospital of Eastern Ontario (CHEO) will be enrolled in a 4-week app-based MB-EAT program (Phase 1, n=10) to evaluate feasibility, usability, and engagement.

Phase 2 is a 12-week randomized controlled trial with 160 participants who will be randomized to the experimental arm (app-based MB-EAT program; 60-90 minutes/week) or an active comparator arm (app-based psychoeducation) to evaluate whether the MB-EAT program improves disinhibited eating. At the end of the intervention, 20 participants will be randomly selected for interviews to explore their experiences with the app.

Additional secondary outcomes in Phase 2 include depressive symptoms, anxiety symptoms, emotion regulation, dispositional mindfulness, food craving, mindful eating, body image, health-related quality of life, impact of weight on quality of life, internalized weight bias, food impulsivity, and food reinforcement.

Detailed Description

Childhood obesity rates in Canada have nearly tripled over the past 30 years, with approximately 25% of youth aged 12 to 17 years classified as overweight or obese according to body mass index standards. Obesity is a chronic disease linked to increased cardiometabolic risk, psychological comorbidities, and reduced quality of life. Traditional behavioural interventions targeting diet and movement behaviours remain standard care but show limited long-term efficacy. This two-phase, double-blind, balanced, parallel-group randomized controlled trial evaluates the feasibility, usability, engagement, and clinical impact of an app-based adaptation of the Mindfulness-Based Eating Awareness Training (MB-EAT) program for adolescents living with obesity.

MB-EAT, developed by Dr. Jean Kristeller, has been shown to reduce binge eating episodes, improve food-related self-control, and decrease depressive symptoms in adults with obesity. The program promotes mindful awareness and self-regulation in response to hunger and satiety cues, without caloric restriction. This study adapts MB-EAT for delivery through the AmDTx-Epiq app (Mobio Interactive, Toronto, ON), developed with input from mindfulness-based intervention therapists, patients, and software engineers. The digital format aims to improve accessibility and scalability for youth awaiting clinical care.

Eligibility criteria include youth aged 12-17.5 years who are waitlisted or have recently been waitlisted for treatment at the Centre for Healthy Active Living (CHAL) at the Children's Hospital of Eastern Ontario (CHEO), have access to a mobile or tablet device with internet, the ability to complete the study in English, and willingness to provide consent/assent. Exclusion criteria include current enrollment in psychotherapy or a weight management program, diagnosis of bulimia nervosa (purging subtype), certain neurodevelopmental conditions (i.e., Fetal Alcohol Syndrome, Down Syndrome, Prader-Willi Syndrome, Fragile X Syndrome, autism spectrum disorder), or concussion/brain injury within the past six months.

Phase 1 enrolls 10 participants to deliver a 4-week app-based MB-EAT program. The primary objective is to evaluate feasibility, usability, and engagement, as indicated by self-reported interest, enrollment rate, adherence, acceptance, working alliance, expectancy and belief credibility, engagement metrics, attrition, and identified barriers and facilitators. Acceptability will be measured with the Client Satisfaction Questionnaire (modified), usability with the System Usability Scale (modified), credibility and expectancy with the Credibility and Expectancy Questionnaire, and working alliance with the Working Alliance Inventory for Guided Internet Interventions. Engagement will be tracked via in-app metrics, with adherence defined as logging in at least 50% of the required time. Enrollment and attrition rates will be monitored, and post-intervention interviews will explore questionnaire responses, barriers to compliance, and facilitators of app use. The secondary objective for Phase 1 is to assess whether the MB-EAT program improves disinhibited eating in this clinical youth sample.

Phase 2 is a 12-week randomized controlled trial with 160 participants who will be randomized to the experimental arm (app-based MB-EAT program; 60-90 minutes/week) or an active comparator arm (app-based psychoeducation on nutrition, physical activity, and weight management from public health and clinical guidelines). Both arms follow 12 weekly modules via the same platform. At the end of the intervention, 20 participants will be randomly selected for interviews to explore their experiences with the app. The primary outcome is to evaluate whether the MB-EAT program improves disinhibited eating, measured by the Three-Factor Eating Questionnaire Revised 18 Version 2. The secondary objectives are to continually assess feasibility, usability, and engagement with the app-based MBI program using the same indicators and measures applied in Phase 1.

Additional secondary outcomes in Phase 2 include depressive symptoms, anxiety symptoms, emotion regulation, dispositional mindfulness, food craving, mindful eating, body image, health-related quality of life, impact of weight on quality of life, internalized weight bias, food impulsivity, and food reinforcement.

Conditions

Obesity &Amp; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phase 1: Feasibility study

Patients in the feasibility study will receive a modified, shortened version of the MB-EAT program through AmDTx-Epiq within the AmDTx app.

Group Type: EXPERIMENTAL

Feasibility study

Intervention Type: BEHAVIORAL

Phase 1 will include 4 modules, delivered across 4 weeks. All participants will receive a modified, shortened version of the MB-EAT program through AmDTx-Epiq within the AmDTx app. Participants will also complete the "Keep in Balance" questionnaire every week on the app, a questionnaire which assesses weekly physically activity and eating habits, as well as associated thoughts and feelings to these. Participants will receive regular "check-ins" twice per week from a coach (unblinded study coordinator) via text designed to promote engagement and answer questions participants may have during the 4-week intervention period.

Phase 2: Control group Arm

Patients allocated to the control group will receive audio-recorded psychoeducation consisting of standard diet/exercise information through the same AmDTx-Epiq in the AmDTx app.

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

Patients in the control group will receive audio-recorded psychoeducation in the form of standard diet/exercise information. The comparator is publicly available psychoeducational information available on nutrition, physical activity, and weight management through best practice guidelines, clinical guidelines, and public health guidelines. These comparators were chosen as they are easily accessible standard of care practices and interventions available in the community (i.e., the general public have access to it in the community), such as through consultation with a dietician, community care provider, or family physician.

Phasee 2: Intervention group

Patients allocated to the intervation arm will receive the manualized and audio-recorded MB-EAT program which will be delivered through modules in the form of a "journey" in the AmDTx app.

Group Type: EXPERIMENTAL

MB-EAT program

Intervention Type: BEHAVIORAL

Phase 2 will include 12 modules, delivered across 12 weeks. The program will contain seated and guided mindfulness practices designed to cultivate better awareness of hunger cues, sensory-specific satiety, as well as external and emotional food-related triggers through body scans, taste satiety and mindful eating practices, self-compassion meditations, and diaphragmatic breathing. The intervention will also include mindful movements. Each session will be focused on a specific theme related to promoting healthy eating behaviours and emotional regulation. Each module will be unlocked as the participant progresses through the program. AmDTx-Epiq also incorporates goal setting, daily feedback, prompts for change, and positive reinforcement in the form of an encouraging text messages from the study coach.

Interventions

MB-EAT program

Phase 2 will include 12 modules, delivered across 12 weeks. The program will contain seated and guided mindfulness practices designed to cultivate better awareness of hunger cues, sensory-specific satiety, as well as external and emotional food-related triggers through body scans, taste satiety and mindful eating practices, self-compassion meditations, and diaphragmatic breathing. The intervention will also include mindful movements. Each session will be focused on a specific theme related to promoting healthy eating behaviours and emotional regulation. Each module will be unlocked as the participant progresses through the program. AmDTx-Epiq also incorporates goal setting, daily feedback, prompts for change, and positive reinforcement in the form of an encouraging text messages from the study coach.

Intervention Type: BEHAVIORAL

Feasibility study

Phase 1 will include 4 modules, delivered across 4 weeks. All participants will receive a modified, shortened version of the MB-EAT program through AmDTx-Epiq within the AmDTx app. Participants will also complete the "Keep in Balance" questionnaire every week on the app, a questionnaire which assesses weekly physically activity and eating habits, as well as associated thoughts and feelings to these. Participants will receive regular "check-ins" twice per week from a coach (unblinded study coordinator) via text designed to promote engagement and answer questions participants may have during the 4-week intervention period.

Intervention Type: BEHAVIORAL

Psychoeducation

Patients in the control group will receive audio-recorded psychoeducation in the form of standard diet/exercise information. The comparator is publicly available psychoeducational information available on nutrition, physical activity, and weight management through best practice guidelines, clinical guidelines, and public health guidelines. These comparators were chosen as they are easily accessible standard of care practices and interventions available in the community (i.e., the general public have access to it in the community), such as through consultation with a dietician, community care provider, or family physician.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Have access to a mobile/tablet device with internet access
• Are aged 12-17.5 years
• Are waitlisted or have recently been waitlised for treatment at CHAL at CHEO
• Are willing and capable to sign consent/assent forms
• Have the ability to complete the study in English

Exclusion Criteria

• Are currently enrolled in psychotherapy or a weight management program
• Have previously been diagnosed with Bulimia Nervosa, purging subtype
• Have previously been diagnosed with a condition that may impair cognition and neurodevelopment, particularly Fetal Alcohol Syndrome, Down Syndrome, Prader-Willi Syndrome, and Fragile X Syndrome
• Have previously been diagnosed with ASD
• Have had a concussion or brain injury in the past 6-months.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gary Goldfield

OTHER

Sponsor Role: lead

Responsible Party

Gary Goldfield

Senior Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gary Goldfield

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Karina Branje

Role: CONTACT

kbranje@cheo.on.ca

613-737-7600 ext. 4899

Facility Contacts

Karina Branje

Role: primary

kbranje@cheo.on.ca

613-737-7600 ext. 4899

Other Identifiers

OBIMBEAT25

Identifier Type: -

Identifier Source: org_study_id