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Satiation Study With Children Attending a Tertiary Feeding Clinic

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04851327
Enrollment
17
Registered
2021-04-20
Start date
2021-05-01
Completion date
2021-08-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undernutrition, Underweight

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.

Interventions

Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink

Tests the amount participants eat at a meal following ingestion of a low energy preload drink

BEHAVIORALTest meal

Test meal to follow low or high energy preload

Sponsors

University of Stirling
CollaboratorOTHER
University of Ghana
CollaboratorOTHER
University of Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Two similar tasting drinks will be used in random order, one low and one high energy After a standardised meal, the weight of food consumed will be measured by an observer blind to which supplement has been used

Intervention model description

cross-over energy compensation study, participants acting as their own controls

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compensation indexCalculated on day 8, after consumption of 2nd test mealThe difference in energy consumed after high compared to low energy preload as percent of energy in preload

Secondary

MeasureTime frameDescription
total energy consumed per study dayCalculated on day 8, after consumption of 2nd test mealThe total amount of energy consumed form preload plus meal after high compared to low energy preload

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026