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

NCT04848129 | Completed

• 1 other identifier: NHSGGC290906Gen
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Undernutrition; Eating Disorders; Underweight

Keywords

Genetics; Child; Eating behaviour; Tube feeding; Avoidant Restrictive food intake disorder

Outcome Measures

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

  Within 1-2 months of recruitment

Secondary Outcomes (2)

• Eating behaviour score

  At recruitment or up to 2 months before

• Body mass index

  Up to two years before genetic test

Interventions

Feeding clinic BEHAVIORAL

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

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Glasgow: lead
• University of Stirling: collaborator

Study Sites (1)

New Lister building, Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition; Feeding and Eating Disorders; Thinness; Feeding Behavior; Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Body Weight; Behavior, Animal; Behavior

Study Officials

• Charlotte Wright, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Community Child Health

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: On request once initial write up is complete - after 2 years
• Access Criteria: Available on request

Locations

GB (1)