Clinical trial NCT04851327: Satiation Study With Children Attending a Tertiary Feeding Clinic
Official title: Behavioural Correlates of Wasting: a Pilot Satiation Study With Children Attending a Tertiary Feeding Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Underweight
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: University of Ghana
First posted: 2021-04-20
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: cross-over energy compensation study, participants acting as their own controls
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compensation index
timeFrame: Calculated on day 8, after consumption of 2nd test meal
Secondary outcomes:
measure: total energy consumed per study day
timeFrame: Calculated on day 8, after consumption of 2nd test meal
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: New Lister building, Royal Infirmary
state: Scotland
Study officials:
affiliation: University of Glasgow
name: Charlotte M Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: