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The MB-EAT Smart Teen Study
Sponsor: Gary Goldfield
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.
Official title: Effects of Application-Based Mindfulness and Eating Awareness Training on Disordered Eating in Youth With Obesity: The MB-EAT Study
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2025-10-01
Completion Date
2028-04-01
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
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.
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.
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.
Locations (1)
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada