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CompletedNCT04848129Updated Apr 7, 2022

Genetic Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic

An observational study in Undernutrition, Eating Disorders and Underweight, sponsored by University of Glasgow. Completed at 1 site in United Kingdom. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by University of Glasgow · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
25
Ages
1 Year to 16 Years
Sex
All
01

Study summary

This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

Read the detailed description

Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

The investigators will invite up to 60 families to complete a standardised online questionnaire (ICFET) about their child's eating behaviour and collect a saliva sample from their child, sent by post. The investigators will identify how many genetic markers for thinness each carries and relate this to their ICFET appetite scores and existing growth measurements as well as their feeding history.

02

Conditions studied

  • Undernutrition
  • Eating Disorders
  • Underweight

Keywords

  • Genetics
  • Child
  • Eating behaviour
  • Tube feeding
  • Avoidant Restrictive food intake disorder
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's enrollment of 25 is below the median of 206 across 393 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University of Glasgow is the lead sponsor of 145 studies on the registry; 21 are open to participants now.

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

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This is a heterogeneous population, united by their difficulties in eating solid food. The majority are, or have previously been, tube fed and around half have some learning disability. Thinness is very common in this group, but we will include all children, whatever their current growth pattern.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All participants currently attending Glasgow Feeding Clinic or assessed there within the last 2 years. NB current ethical application is restricted to children aged 1-7 years, but the investigators plan to apply to extend that to age 16 years.

Exclusion criteria

Exclusion Criteria:

Sample not to be collected with 2 weeks of any symptoms or recent contact with Covid 19

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • BehavioralFeeding clinic

    These children have all attended a multidisciplinary feeding clinic with severe food refusal and were commonly receiving tube feeding or supplement drinks. The clinic helps children progress onto a normal oral diet

    Also known as: tube weaning

06

What researchers measure

Primary outcomes

  1. Genotype risk score

    This the number of risk polymorphisms present for each child ranges from 0-20. a high score suggests more thinness

    Time frame: Within 1-2 months of recruitment

Secondary outcomes

  1. Eating behaviour score

    Measure of appetite and food refusal assessed using standard questionnaire (International Complementary Feeding Evaluation Tool (ICFET) Score from 1-5, hihger score suggests greater avidity

    Time frame: At recruitment or up to 2 months before

  2. Body mass index

    weight (kg)/Height (m) squared

    Time frame: Up to two years before genetic test

07

Study locations

1 site
  • New Lister building, Royal Infirmary
    Glasgow, Scotland G31 2ER, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — The individual anonymized data would be made available on request for a collaborative genetic study

Supporting information: Study protocol, Informed consent form

Time frame: On request once initial write up is complete - after 2 years

Access criteria: Available on request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Dec 2021, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2021
First posted
Apr 19, 2021
StartActual
May 1, 2021
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Apr 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04848129
Collaborators
University of Stirling
Responsible party
Charlotte Wright (Professor of Community Child Health, University of Glasgow) — Principal investigator
First posted
Apr 19, 2021
Start date
May 1, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Apr 7, 2022

Study contacts

Charlotte Wright, MD
principal investigator · University of Glasgow

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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