跳至主要内容
临床试验/NCT04851327
NCT04851327已完成不适用

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

University of Glasgow2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Compensation index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Compensation index

时间窗: Calculated on day 8, after consumption of 2nd test meal

The difference in energy consumed after high compared to low energy preload as percent of energy in preload

次要结局

  • total energy consumed per study day(Calculated on day 8, after consumption of 2nd test meal)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Wright

Professor of Community Child Health

University of Glasgow

研究点 (2)

Loading locations...

相似试验