About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MB-EAT program
- Feasibility study
- Psychoeducation
Treatment groups
Sponsors and collaborators
Gary Goldfield
Lead sponsor
Children's Hospital of Eastern Ontario
Sponsor institution