CClinicalTrials.gg
RecruitingNCT07865117MybYteUpdated Oct 8, 2026

Development of a Digital Personalised Nutrition Tool for Adolescents Undergoing Cancer Treatment

An interventional study of The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment in Paediatric Oncology and Malnutrition in Children, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by KU Leuven · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Paediatric Oncology
  • Malnutrition in Children

Keywords

  • adolescent
  • cancer
  • personalised nutrition
  • mHealth
  • Digital health
  • experience sampling method
03

In context

Child Nutrition Disorders

164 studies on the registry are indexed under Child Nutrition Disorders; 34 are open to participants now.

This study's planned enrollment of 30 is below the median of 428 across 130 interventional studies indexed under Child Nutrition Disorders.

Browse Child Nutrition Disorders studies →

Lead sponsor

KU Leuven is the lead sponsor of 359 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria Phase 1 and 2:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Phase 2: MybYte digital personalised nutrition tool

    Other: The MybYte tool, a digital personalised nutrition tool for adolescents undergoing cancer treatment

Interventions

  • OtherThe 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.

06

What researchers measure

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 8

  2. 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 6

  3. 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 6

Secondary 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 one

  2. 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 6

  3. 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 6

  4. 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

  5. Phase angle (degrees)

    Phase 2: Phase angle (degrees) measured monthly by the Bodystat Multiscan 5000 bioelectrical impedance spectroscopy

    Time frame: From enrollment into phase 2 until the end of month 6

  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.

    Time frame: From enrollment into phase 2 until the end of month 6.

  7. 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.

    Time frame: From enrollment into phase 2 to end of month 6.

  8. 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)

    Time frame: From enrollment into phase 2 to the end of month 6

  9. 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)

    Time frame: From enrollment into phase 2 until the end of month 6

  10. 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.

    Time frame: From enrollment into phase 2 to the end of month 6.

  11. 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.

    Time frame: From enrollment into phase 2 until the end of month 6

07

Study locations

1 of 1 sites recruiting
  • University Hospitals Leuven (UZ Leuven)
    Leuven, Vlaams Brabant 3000, Belgium
    Recruiting
08

References and documents

Study documents

  • Study protocol · Jul 16, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865117
Lead sponsor
KU Leuven
Responsible party
Christophe Matthys (Professor Dr, KU Leuven) — Principal investigator
First posted
Oct 8, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Joanna M Eksteen
Contact
jo.eksteen@kuleuven.be
+32 163 47205

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion