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

March 29, 2022 updated by: Charlotte Wright, University of Glasgow

What Makes Children Thin? Genetic and Behavioural Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype risk score
Time Frame: Within 1-2 months of recruitment
This the number of risk polymorphisms present for each child ranges from 0-20. a high score suggests more thinness
Within 1-2 months of recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating behaviour score
Time Frame: At recruitment or up to 2 months before
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
At recruitment or up to 2 months before
Body mass index
Time Frame: Up to two years before genetic test
weight (kg)/Height (m) squared
Up to two years before genetic test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Charlotte Wright, MD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual anonymized data would be made available on request for a collaborative genetic study

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Available on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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