The MB-EAT Smart Teen Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorGary Goldfield

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

170 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Gary Goldfield

Lead sponsor

Children's Hospital of Eastern Ontario

Sponsor institution