Satiation Study With Children Attending a Tertiary Feeding Clinic

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

This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if thin children respond to food in the same way, using an established method to assess energy compensation.

Study Overview

• Status: Completed
• Conditions: Undernutrition; Underweight
• Intervention / Treatment: Behavioral: High Energy preload; Behavioral: Test meal; Behavioral: Low energy preload

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.

A Ghanaian student will come to Glasgow, funded by the Glasgow University /Scottish funding council Global Challenges Research fund, to learn these techniques to use in future PhD research. The student will conduct a pilot study of children attending the GFC. The student will invite 40 families to complete our standardised online questionnaire (ICFET) about their child's eating behaviour and collate existing growth measurements as well as their feeding history.

A standardised energy compensation study will then be undertaken in 20 of the thinnest children. At two visits at least a week apart, the children will be given one of two similar tasting drinks in random order, one with very few calories and another with extra, without them knowing which is which. After 30 minutes they will eat as much as they want of a standardized lunch. All foods and drinks offered will be weighed before and after, to calculate the amount of energy eaten in total after the low energy drink, compared to the high energy drink.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently attending Glasgow Feeding Clinic or seen within the last 2 years.
• Completed ICFET questionnaire and eating solid food at least weekly.
• Body mass index < 9th centile.
• Within 40 minutes car travel from study centre

Exclusion Criteria:

• Patient or family member shielding from COVID.
• Not able to swallow safely
• Not taking solid foods
• Fully tube fed: i.e. receiving more than 75% of energy requirements from tube feeding.

No measurements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High energy; Child will be given a high energy drink: a flavoured high energy milk or juice-based drink, used clinically to supplement the diet of preschool children (either Pediasure plus or Duocal). This will provide 1.5 kcals per ml in various flavours as preferred. The amount given will supply 10% of the child's daily energy requirements per Kg - for example for a 2-year-old child weighing 15 KG this would be 80 mls of drink supplying 120 Kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing a range of pre-packaged foods of known energy content suitable for their age, chosen in consultation with the parents.	Behavioral: High Energy preload; Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink; Other Names: Satiation study; Behavioral: Test meal; Test meal to follow low or high energy preload
Experimental: Low energy; Child will be given a low energy drink of the same volume selected to be as similar as possible to the high energy drink, made either of skim milk or sugar free fruit juice, with a similar sugar free flavour; for above example this will supply 25 kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of pre-packaged foods as above.	Behavioral: Test meal; Test meal to follow low or high energy preload; Behavioral: Low energy preload; Tests the amount participants eat at a meal following ingestion of a low energy preload drink; Other Names: Satiation study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compensation index	The difference in energy consumed after high compared to low energy preload as percent of energy in preload	Calculated on day 8, after consumption of 2nd test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total energy consumed per study day	The total amount of energy consumed form preload plus meal after high compared to low energy preload	Calculated on day 8, after consumption of 2nd test meal

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: University of Ghana; University of Stirling
• Investigators: Principal Investigator: Charlotte M Wright, MD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 20, 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

• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Malnutrition; Thinness
• Other Study ID Numbers: NHSGGC290906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data may be made available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No