[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659543":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":69,"studyPopulation":61,"armGroups":70,"interventions":76,"overallOfficials":61,"centralContacts":81,"locations":87,"responsibleParty":107,"collaborators":61,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":61,"studyType":125,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":90,"whyStopped":61,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":61},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"The MybYte tool","Phase 1: Final version of MybYte, a digital personalised nutrition tool for adolescents undergoing cancer treatment","From the time of enrollment into phase 1 until month 8",{"measure":14,"description":15,"timeFrame":16},"Feasibility (%)","Phase 2: Feasibility of the MybYte tool determined by engagement (%), recruitment (%), and retention (%)","From enrollment into phase 2 until end of month 6",{"measure":18,"description":19,"timeFrame":16},"Acceptability (5 point response scale)","Phase 2: Acceptability of the MybYte tool will be determined by questionnaire at month 3 and 6, including a 5 point response scale to the following categories: engagement, functionality, aesthetics, content, relevance, interference, quality, and perceived impact.",[21,25,29,32,36,40,44,48,51,54,58],{"measure":22,"description":23,"timeFrame":24},"Adolescent perspectives of nutrition during cancer treatment","Phase 1: Thematic analysis of semi-structured interviews exploring adolescents' lived experiences regarding nutrition, nutritional status, and nutrition communication during cancer treatment","From enrollment into phase 1 to end of month one",{"measure":26,"description":27,"timeFrame":28},"Fat mass (kg)","Phase 2: Fat mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy","From enrollment into phase 2 to the end of month 6",{"measure":30,"description":31,"timeFrame":16},"Fat free mass (kg)","Phase 2: Fat free mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy",{"measure":33,"description":34,"timeFrame":35},"Skeletal muscle mass (kg)","Phase 2: skeletal muscle mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy","From the time on enrollment into phase 2 until the end of month 6",{"measure":37,"description":38,"timeFrame":39},"Phase angle (degrees)","Phase 2: Phase angle (degrees) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy","From enrollment into phase 2 until the end of month 6",{"measure":41,"description":42,"timeFrame":43},"Body mass index (kg\u002Fm^2)","Phase 2: Body mass index. weight (kg) and height (m) will be combined to report BMI in kg\u002Fm\\^2.","From enrollment into phase 2 until the end of month 6.",{"measure":45,"description":46,"timeFrame":47},"Resting energy metabolism (kcal\u002Fday)","Phase 2: Resting energy metabolism (kcal\u002Fday) measured monthly via the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy and at diagnosis, month 3, and month 6 using indirect calorimetry.","From enrollment into phase 2 to end of month 6.",{"measure":49,"description":50,"timeFrame":28},"Generic health- related quality of life (5 point response scale)","Phase 2: Health- related quality of life at diagnosis, months 3, and 6 using the PedsQL 4.0. Items are rated on a 5-point response scale ranging from 0 (never a problem) to 4 (almost always a problem)",{"measure":52,"description":53,"timeFrame":39},"Cancer specific health-related quality of life (5 point response scale)","Phase 2: Cancer specific health-related quality of life measured at diagnosis, month 3, and month 6 by the PedsQL 3.0 Cancer Module. Items are rated on a 5-point response scale ranging from 0 (never a problem) to 4 (almost always a problem)",{"measure":55,"description":56,"timeFrame":57},"Macronutrient dietary intake (g\u002Fday)","Phase 2: Protein, fat, and carbohydrate intake (g\u002Fday), measured over 7 days per month for 6 months using the MybYte tool.","From enrollment into phase 2 to the end of month 6.",{"measure":59,"description":60,"timeFrame":39},"Dietary food group intake (g\u002Fday)","Phase 2: Dietary food group intake (g\u002Fday), measured over 7 days per month for 6 months using the MybYte tool.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":61,"timePerspective":61,"maskingInfo":67},"NA","SEQUENTIAL","This is a two-phase sequential mixed-methods study comprising a qualitative co-design (phase 1, sample 1) followed by a single-arm feasibility study (phase 2, sample 2). In phase 1 participants (sample 1) will be interviewed and will co-create the MybYte tool alongside researchers during an iterative process.\n\nIn phase 2 (sample 2), all participants will receive the MybYte intervention and will use the smartphone tool for 7 consecutive days each month over a 6-month period. Feasibility, acceptability, engagement and usability will be assessed during the intervention period, together with selected nutritional, body composition and patient-reported measures collected during routine study assessments. There is no concurrent control or comparison group.","SUPPORTIVE_CARE",{"masking":68,"maskingDescription":61,"whoMasked":61},"NONE","See uploaded protocol",[71],{"label":72,"type":73,"description":61,"interventionNames":74},"Phase 2: MybYte digital personalised nutrition tool","EXPERIMENTAL",[75],"Other: The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment",[77],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":61},"The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment","In Phase 2, a feasibility and acceptability study, all participants will use MybYte for 7 days each month over 6 months. Using experience sampling methodology (ESM), the tool sends 3-5 brief prompts per day about dietary intake, treatment-related symptoms and side effects, appetite, and taste preferences. Based on their responses, participants receive immediate, targeted nutrition tips. Once a month, researchers will integrate body composition and dietary intake data to provide more personalised nutrition feedback and advice. The tool is primarily a health communication tool.",[72],[82],{"name":83,"role":84,"phone":85,"phoneExt":61,"email":86},"Joanna M Eksteen","CONTACT","+32 163 47205","jo.eksteen@kuleuven.be",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"University Hospitals Leuven (UZ Leuven)","RECRUITING","Leuven","Vlaams Brabant","3000","Belgium","BE",{"type":97,"coordinates":98},"Point",[99,100],4.70093,50.87959,{"lat":100,"lon":99},[103],{"name":104,"role":84,"phone":105,"phoneExt":61,"email":106},"Julie Messiaen, Peadiatric Oncologist MD","+32 16 34 39 72","julie.1.messiaen@uzleuven.be",{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"PRINCIPAL_INVESTIGATOR","Christophe Matthys","Professor Dr","100659543","development-of-a-digital-personalised-nutrition-tool-for-adolescents-undergoing-cancer-treatment-100659543",false,"NCT07865117","Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment","Digital Innovation for Personalised Nutrition in Adolescent Oncology","MybYte","Inclusion Criteria\n\n* Written informed consent has been obtained from a parent\u002Flegal guardian.\n* Written assent has been obtained from participants.\n* Aged between 12 and 18 years at the time of enrolment.\n* Ability to use a smartphone independently.\n* Adequate cognitive capacity to participate in study procedures, as determined by the research team.\n* Proficiency in Dutch\n* For Phase 1:\n* Currently receiving, or having previously received cancer treatment (including chemotherapy) at University Hospitals Leuven within the specified age range.\n* For Phase 2:\n* New histological diagnosis of cancer\n* Enrolled into the study within 6 weeks of diagnosis.\n* Currently receiving cancer treatment (including chemotherapy) at University Hospitals Leuven.\n\nExclusion Criteria Phase 1 and 2:\n\n* Presence of cognitive, developmental, or neurological impairments that compromise the ability to provide informed consent or assent, or that impair \\\\ independent use of a digital tool\n* Medical instability or clinical condition deemed too unwell for participation, as determined by the treating clinician.\n* Admitted to the intensive care unit during the enrollment period.\n* Currently on a palliative care trajectory.","ALL","12 Years","18 Years",{"count":123,"type":124},30,"ESTIMATED","INTERVENTIONAL",[63],"This study aims to develop and test MybYte, a smartphone tool designed to support personalised nutrition for teenagers aged 12-18 undergoing cancer treatment. MybYte will ask short questions about eating, appetite and treatment-related symptoms and provide personalised nutrition advice developed by healthcare professionals. In Phase 1, around 15 teenagers will help co-design and refine the tool through interviews and feedback. In Phase 2, around 15 newly diagnosed teenagers will use MybYte for one week each month over six months, alongside routine assessments of nutrition, body composition, taste, energy needs and quality of life. The study will assess whether MybYte is acceptable, practical and helpful for teenagers receiving cancer treatment.",[129,130],"Paediatric Oncology","Malnutrition in Children",[132,133,134,135,136,137],"adolescent","cancer","personalised nutrition","mHealth","Digital health","experience sampling method","2026-10-05",{"date":140,"type":141},"2026-10-08","ACTUAL",{"date":143,"type":124},"2026-09",{"date":145,"type":124},"2029-03",{"name":5,"class":6},1]