Clinical trial
The MB-EAT Smart Teen Study
Opening soon · Not applicable · 1 countries · Registry ID NCT07130838
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
Acceptability will be measured with a modified version of the client satisfaction questionnaire (CSQ). The CSQ is a valid, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or service. The questionnaire has been modified to assess participant satisfaction with the app and is measured with a Likert scale 1 to 4. Higher scores indicating greater satisfaction.
Usability of the app will be measured using a modified version of the System Usability Scale (SUS). The SUS is a valid and reliable 10-item measure that is used to assess the usability of a system or program with a Likert scale 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate better usability.
The quality of the working alliance with the AmDTx app will be assessed with the Working Alliance Inventory for guided Internet Interventions (WAI-I). The WAI-I is a validated and reliable 12-item questionnaire rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The scale has been modified to measure working alliance with the app based MBI. The responses are averaged into a total scale (range 1-5), and two sub-scores: Task and goal agreement with the program (8 items; range 1-5); Bond with the guides (4 items; range 1-5). Higher scores indicate better alliance.
Engagement with the MBI will be tracked via data collected from the AmDTx app. Engagement will be measured by logins, the number of completed resilience, relaxation and/or psychoeducation sessions + total number of self-assessments of psychological wellbeing + total number of "mindful minutes" (a composite of meaningful engagement with the digital therapeutic), and overall time spent using "meaningful" features within the AmDTx app. Engagement is automatically and anonymously captured for the 4 weeks (the length of the intervention). "Meaningful" refers to features that provide potential benefit for the patient, but do not include neutral engagement such as time spent on the product home screen.
Adherence will be measured by the number of times the participant used the intervention, defined as logging into the application 50% of the required time.
Enrollment and attrition rates will be kept track of using a tracking log.
The potential usefulness and benefits of AmDTx app will be explored via interviews with participants at the end of the intervention phase (4-week follow up), obtaining patient perspective with the app and their respective thoughts on therapeutic utility.
Disinhibited Eating (susceptibility to overeat compulsively) will be measured by the Three-Factor Eating Questionnaire Revised 18 Version 2 (TFEQ-R18 V2) which is a likert scale from 1 (definitely true) to 4 (definitely false). High scores on a scale reflect a higher level of disinhibited eating.
Study locations
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