Effects of Application-Based Mindfulness and Eating Awareness Training on Disordered Eating in Youth With Obesity: The MB-EAT Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Phase 1: Enrollment and attrition rates
研究概览
简要总结
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.
详细描述
Childhood obesity rates in Canada have nearly tripled over the past 30 years, with approximately 25% of youth aged 12 to 17 years classified as overweight or obese according to body mass index standards. Obesity is a chronic disease linked to increased cardiometabolic risk, psychological comorbidities, and reduced quality of life. Traditional behavioural interventions targeting diet and movement behaviours remain standard care but show limited long-term efficacy. 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, developed by Dr. Jean Kristeller, has been shown to reduce binge eating episodes, improve food-related self-control, and decrease depressive symptoms in adults with obesity. The program promotes mindful awareness and self-regulation in response to hunger and satiety cues, without caloric restriction. This study adapts MB-EAT for delivery through the AmDTx-Epiq app (Mobio Interactive, Toronto, ON), developed with input from mindfulness-based intervention therapists, patients, and software engineers. The digital format aims to improve accessibility and scalability for youth awaiting clinical care.
Eligibility criteria include 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), have access to a mobile or tablet device with internet, the ability to complete the study in English, and willingness to provide consent/assent. Exclusion criteria include current enrollment in psychotherapy or a weight management program, diagnosis of bulimia nervosa (purging subtype), certain neurodevelopmental conditions (i.e., Fetal Alcohol Syndrome, Down Syndrome, Prader-Willi Syndrome, Fragile X Syndrome, autism spectrum disorder), or concussion/brain injury within the past six months.
Phase 1 enrolls 10 participants to deliver a 4-week app-based MB-EAT program. The primary objective is to evaluate feasibility, usability, and engagement, as indicated by self-reported interest, enrollment rate, adherence, acceptance, working alliance, expectancy and belief credibility, engagement metrics, attrition, and identified barriers and facilitators. Acceptability will be measured with the Client Satisfaction Questionnaire (modified), usability with the System Usability Scale (modified), credibility and expectancy with the Credibility and Expectancy Questionnaire, and working alliance with the Working Alliance Inventory for Guided Internet Interventions. Engagement will be tracked via in-app metrics, with adherence defined as logging in at least 50% of the required time. Enrollment and attrition rates will be monitored, and post-intervention interviews will explore questionnaire responses, barriers to compliance, and facilitators of app use. The secondary objective for Phase 1 is to assess whether the MB-EAT program improves disinhibited eating in this clinical youth sample.
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 on nutrition, physical activity, and weight management from public health and clinical guidelines). Both arms follow 12 weekly modules via the same platform. At the end of the intervention, 20 participants will be randomly selected for interviews to explore their experiences with the app. The primary outcome is to evaluate whether the MB-EAT program improves disinhibited eating, measured by the Three-Factor Eating Questionnaire Revised 18 Version 2. The secondary objectives are to continually assess feasibility, usability, and engagement with the app-based MBI program using the same indicators and measures applied in Phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Phase 1: Feasibility study
Patients in the feasibility study will receive a modified, shortened version of the MB-EAT program through AmDTx-Epiq within the AmDTx app.
干预措施: Feasibility study (Behavioral)
Phase 2: Control group Arm
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.
干预措施: Psychoeducation (Behavioral)
Phasee 2: Intervention group
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.
干预措施: MB-EAT program (Behavioral)
结局指标
主要结局
Phase 1: Enrollment and attrition rates
时间窗: 1 month
Enrollment and attrition rates will be kept track of using a tracking log.
Phase 1: Acceptability
时间窗: 1 month
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.
Phase 1: Usability
时间窗: 1 month
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.
Phase 1: Working alliance
时间窗: 1 month
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.
Phase 1: Engagement
时间窗: 1 month
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.
Phase 1: Adherence
时间窗: 1 month
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.
Phase 1: Barriers and facilitators
时间窗: 1 month
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.
Phase 2: Disinhibited eating
时间窗: 24 weeks
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.
次要结局
- 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)
- Phase 1 & 2: Disordered eating(4 weeks & 24 weeks)
- Phase 2: Adherence(12 weeks)
- Phase 2: Engagement(12 weeks)
- Phase 2: Working alliance(12 weeks)
- Phase 2: Barriers and facilitators(12 weeks)
- Phase 1 & 2: Food craving(4 weeks & 24 weeks)
- Phase 1 & 2: Mindful eating(4 weeks & 24 weeks)
- Phase 1 & 2: Body image(4 weeks & 24 weeks)
- Phase 2: Enrollment and attrition rates(12 weeks)
- Phase 2: Usability(12 weeks)
- Phase 2: Acceptability(12 weeks)
- Phase 1 & 2: Health-related quality of life(4 weeks & 24 weeks)
- Phase 1 & 2: Impact of weight on quality of life(4 weeks & 24 weeks)
- Phase 1 & 2: Internalized weight bias(4 weeks & 24 weeks)
- Phase 1 & 2: Food reinforcement(4 weeks & 24 weeks)
- Phase 1 & 2: Energy intake(4 weeks & 24 weeks)
- Phase 1 & 2: Food impulsivity(4 weeks & 24 weeks)
研究者
Gary Goldfield
Senior Scientist
Children's Hospital of Eastern Ontario
