Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorKU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent has been obtained from a parent/legal guardian.
Written assent has been obtained from participants.
Aged between 12 and 18 years at the time of enrolment.
Ability to use a smartphone independently.
Disqualifiers
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
Medical instability or clinical condition deemed too unwell for participation, as determined by the treating clinician.
Admitted to the intensive care unit during the enrollment period.
Currently on a palliative care trajectory.
Trial design
Design model
Sequential
Treatments tested in this trial
The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment
Other interventionIn 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Phase 2: MybYte digital personalised nutrition toolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The MybYte tool
Phase 1: Final version of MybYte, a digital personalised nutrition tool for adolescents undergoing cancer treatment
Time frame
From the time of enrollment into phase 1 until month 82
Feasibility (%)
Phase 2: Feasibility of the MybYte tool determined by engagement (%), recruitment (%), and retention (%)
Time frame
From enrollment into phase 2 until end of month 63
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.
Time frame
From enrollment into phase 2 until end of month 6Secondary outcomes
1
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
Time frame
From enrollment into phase 1 to end of month one2
Fat mass (kg)
Phase 2: Fat mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Time frame
From enrollment into phase 2 to the end of month 63
Fat free mass (kg)
Phase 2: Fat free mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Time frame
From enrollment into phase 2 until end of month 64
Skeletal muscle mass (kg)
Phase 2: skeletal muscle mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Time frame
From the time on enrollment into phase 2 until the end of month 6 Source ClinicalTrials.gov