Paediatric OncologyMybYteNCT07865117
Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment
A study testing The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment in people with Paediatric Oncology and Malnutrition in Children, run by KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Paediatric Oncology, Malnutrition in Children
- What is being tested?
- The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- Adequate cognitive capacity to participate in study procedures, as determined by the research team.
- Proficiency in Dutch
Show all 12Show fewer
- For Phase 1:
- Currently receiving, or having previously received cancer treatment (including chemotherapy) at University Hospitals Leuven within the specified age range.
- For Phase 2:
- New histological diagnosis of cancer
- Enrolled into the study within 6 weeks of diagnosis.
- Currently receiving cancer treatment (including chemotherapy) at University Hospitals Leuven.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven (UZ Leuven)
Leuven, Vlaams Brabant, 3000
Julie Messiaen, Peadiatric Oncologist MD, +32 16 34 39 72, julie.1.messiaen@uzleuven.be
About this study
Official title: Digital Innovation for Personalised Nutrition in Adolescent Oncology
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.
Read the detailed description
See uploaded protocol
- Conditions
- Paediatric Oncology, Malnutrition in Children
- Being tested
- The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment
- Keywords
- adolescent, cancer, personalised nutrition, mHealth, Digital health, experience sampling method
- Medical subject headings
- Child Nutrition Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: MybYte digital personalised nutrition tool | Experimental | Not described Receives: Other: The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MybYte tool
Phase 1: Final version of MybYte, a digital personalised nutrition tool for adolescents undergoing cancer treatment
Measured: From the time of enrollment into phase 1 until month 8
Feasibility (%)
Phase 2: Feasibility of the MybYte tool determined by engagement (%), recruitment (%), and retention (%)
Measured: From enrollment into phase 2 until end of month 6
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.
Measured: From enrollment into phase 2 until end of month 6
Secondary outcomes (11)
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
Measured: From enrollment into phase 1 to end of month one
Fat mass (kg)
Phase 2: Fat mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Measured: From enrollment into phase 2 to the end of month 6
Fat free mass (kg)
Phase 2: Fat free mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Measured: From enrollment into phase 2 until end of month 6
Skeletal muscle mass (kg)
Phase 2: skeletal muscle mass (kg) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Measured: From the time on enrollment into phase 2 until the end of month 6
Phase angle (degrees)
Phase 2: Phase angle (degrees) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy
Measured: From enrollment into phase 2 until the end of month 6
Body mass index (kg/m^2)
Phase 2: Body mass index. weight (kg) and height (m) will be combined to report BMI in kg/m^2.
Measured: From enrollment into phase 2 until the end of month 6.
Resting energy metabolism (kcal/day)
Phase 2: Resting energy metabolism (kcal/day) measured monthly via the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy and at diagnosis, month 3, and month 6 using indirect calorimetry.
Measured: From enrollment into phase 2 to end of month 6.
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)
Measured: From enrollment into phase 2 to the end of month 6
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)
Measured: From enrollment into phase 2 until the end of month 6
Macronutrient dietary intake (g/day)
Phase 2: Protein, fat, and carbohydrate intake (g/day), measured over 7 days per month for 6 months using the MybYte tool.
Measured: From enrollment into phase 2 to the end of month 6.
Dietary food group intake (g/day)
Phase 2: Dietary food group intake (g/day), measured over 7 days per month for 6 months using the MybYte tool.
Measured: From enrollment into phase 2 until the end of month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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. In 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Matthys, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865117
- Sponsor's protocol ID
- S72397
- Other IDs
- G054226N
- Acronym
- MybYte
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study involves a small number of adolescent participants and collects sensitive health-related data, which could increase the risk of participant re-identification. Study findings will be reported in accordance with applicable privacy and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Innovation for Personalised Nutrition in Adolescent Oncology
- ClinicalTrials.gov ID
- NCT07865117
- Acronym / sponsor ID
- MybYte / S72397
- Conditions
- Paediatric Oncology, Malnutrition in Children
- Keywords
- adolescent, cancer, personalised nutrition, mHealth, Digital health, experience sampling method
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See uploaded protocol
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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. In 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 2: MybYte digital personalised nutrition tool | Experimental | Other: The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
- Adequate cognitive capacity to participate in study procedures, as determined by the research team.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatmentIn 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. | Other | Phase 2: MybYte digital personalised nutrition tool |
Primary outcome
The MybYte tool
Time frame: From the time of enrollment into phase 1 until month 8
Phase 1: Final version of MybYte, a digital personalised nutrition tool for adolescents undergoing cancer treatment
Feasibility (%)
Time frame: From enrollment into phase 2 until end of month 6
Phase 2: Feasibility of the MybYte tool determined by engagement (%), recruitment (%), and retention (%)
Acceptability (5 point response scale)
Time frame: From enrollment into phase 2 until end of month 6
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.
11 secondary outcomes
Adolescent perspectives of nutrition during cancer treatment
Time frame: From enrollment into phase 1 to end of month one
Fat mass (kg)
Time frame: From enrollment into phase 2 to the end of month 6
Fat free mass (kg)
Time frame: From enrollment into phase 2 until end of month 6
Skeletal muscle mass (kg)
Time frame: From the time on enrollment into phase 2 until the end of month 6
Phase angle (degrees)
Time frame: From enrollment into phase 2 until the end of month 6
Body mass index (kg/m^2)
Time frame: From enrollment into phase 2 until the end of month 6.
Resting energy metabolism (kcal/day)
Time frame: From enrollment into phase 2 to end of month 6.
Generic health- related quality of life (5 point response scale)
Time frame: From enrollment into phase 2 to the end of month 6
Cancer specific health-related quality of life (5 point response scale)
Time frame: From enrollment into phase 2 until the end of month 6
Macronutrient dietary intake (g/day)
Time frame: From enrollment into phase 2 to the end of month 6.
Dietary food group intake (g/day)
Time frame: From enrollment into phase 2 until the end of month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study involves a small number of adolescent participants and collects sensitive health-related data, which could increase the risk of participant re-identification. Study findings will be reported in accordance with applicable privacy and data-protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment in people with Paediatric Oncology and Malnutrition in Children, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna M Eksteen (+32 163 47205, jo.eksteen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MybYte tool (time frame: From the time of enrollment into phase 1 until month 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.