[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603001":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":51,"responsibleParty":66,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":31,"overallStatus":89,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Children's Hospital of Eastern Ontario","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Feasibility study",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase 2: Control group Arm","ACTIVE_COMPARATOR","Patients allocated to the control group will receive audio-recorded psychoeducation consisting of standard diet\u002Fexercise information through the same AmDTx-Epiq in the AmDTx app.",[19],"Behavioral: Psychoeducation",{"label":21,"type":10,"description":22,"interventionNames":23},"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.",[24],"Behavioral: MB-EAT program",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","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.",[21],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"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.",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Psychoeducation","Patients in the control group will receive audio-recorded psychoeducation in the form of standard diet\u002Fexercise 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.",[15],[41],{"name":42,"affiliation":5,"role":43},"Gary Goldfield","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Karina Branje","CONTACT","613-737-7600","4899","kbranje@cheo.on.ca",[52],{"facility":5,"status":31,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Ottawa","Ontario","K1Y 0Z7","Canada","CA",{"type":59,"coordinates":60},"Point",[61,62],-75.69812,45.41117,{"lat":62,"lon":61},[65],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},{"type":67,"investigatorFullName":42,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Senior Scientist","100603001","the-mb-eat-smart-teen-study-100603001",false,"NCT07130838","The MB-EAT Smart Teen Study","Effects of Application-Based Mindfulness and Eating Awareness Training on Disordered Eating in Youth With Obesity: The MB-EAT Study","MB-EAT","Inclusion Criteria:\n\n* Have access to a mobile\u002Ftablet device with internet access\n* Are aged 12-17.5 years\n* Are waitlisted or have recently been waitlised for treatment at CHAL at CHEO\n* Are willing and capable to sign consent\u002Fassent forms\n* Have the ability to complete the study in English\n\nExclusion Criteria:\n\n* Are currently enrolled in psychotherapy or a weight management program\n* Have previously been diagnosed with Bulimia Nervosa, purging subtype\n* 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\n* Have previously been diagnosed with ASD\n* Have had a concussion or brain injury in the past 6-months.","ALL","12 Years","17 Years",{"count":81,"type":82},170,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nMB-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.\n\nYouth 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.\n\nPhase 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\u002Fweek) 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.\n\nAdditional 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.",[88],"Obesity &Amp; Overweight","NOT_YET_RECRUITING","2025-08-18",{"date":92,"type":93},"2025-08-19","ACTUAL",{"date":95,"type":82},"2025-10-01",{"date":97,"type":82},"2028-04-01",{"name":42,"class":6},1]