The MB-EAT Smart Teen Study

NCT07130838 | Not Yet Recruiting DMC

• 1 other identifier: OBIMBEAT25
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (8)

• Phase 1: Acceptability

  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.

  1 month

• Phase 1: Usability

  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.

  1 month

• Phase 1: Working alliance

  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.

  1 month

• Phase 1: Engagement

  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.

  1 month

• Phase 1: Adherence

  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.

  1 month

• Phase 1: Enrollment and attrition rates

  Enrollment and attrition rates will be kept track of using a tracking log.

  1 month

• Phase 1: Barriers and facilitators

  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.

  1 month

• Phase 2: Disinhibited eating

  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.

  24 weeks

Secondary Outcomes (22)

• Phase 1: Disinhibited Eating

  1 month

• Phase 1 & 2: Depressive symptoms

  4 weeks & 24 weeks

• Phase 1 & 2: Anxiety symptoms

  4 weeks & 24 weeks

• Phase 1 & 2: Emotional regulation

  4 weeks & 24 weeks

• Phase 1 & 2: Dispositional mindfulness

  4 weeks & 24 weeks

Study Arms (3)

Phase 1: Feasibility study

EXPERIMENTAL

Patients in the feasibility study will receive a modified, shortened version of the MB-EAT program through AmDTx-Epiq within the AmDTx app.

Behavioral: Feasibility study

Phase 2: Control group Arm

ACTIVE COMPARATOR

Patients allocated to the control group will receive audio-recorded psychoeducation consisting of standard diet/exercise information through the same AmDTx-Epiq in the AmDTx app.

Behavioral: Psychoeducation

Phasee 2: Intervention group

EXPERIMENTAL

Patients allocated to the intervation arm will receive the manualized and audio-recorded MB-EAT program which will be delivered through modules in the form of a "journey" in the AmDTx app.

Behavioral: MB-EAT program

Interventions

MB-EAT program BEHAVIORAL

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.

Phasee 2: Intervention group

Feasibility study BEHAVIORAL

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.

Phase 1: Feasibility study

Psychoeducation BEHAVIORAL

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.

Phase 2: Control group Arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Have the ability to complete the study in English

You may not qualify if:

• 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
• Have had a concussion or brain injury in the past 6-months.

Sponsors & Collaborators

• Gary Goldfield: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1Y 0Z7, Canada

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gary Goldfield

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Branje

CONTACT

613-737-7600; kbranje@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Phase 1: Single arm intervention Phase 2: Parallel arm intervention

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CA (1)