The MB-EAT Smart Teen Study

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.

• Phase 1: Disinhibited Eating [Срок оценки: 1 month]
• Phase 1 & 2: Depressive symptoms [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Anxiety symptoms [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Emotional regulation [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Dispositional mindfulness [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Disordered eating [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Food craving [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Mindful eating [Срок оценки: 4 weeks & 24 weeks]
• Phase 1 & 2: Body image [Срок оценки: 4 weeks & 24 weeks]
• Phase 2: Enrollment and attrition rates [Срок оценки: 12 weeks]
• Phase 2: Adherence [Срок оценки: 12 weeks]
• Phase 2: Engagement [Срок оценки: 12 weeks]