Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
Study NCT ID:
NCT05217550
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Veggie Brek Intervention
Sponsor:
Loughborough University
Organization:
Study Overview
Official Title:
Veggie Brek: The Feasibility and Acceptability of Offering Vegetables to Children at Breakfast Time in a Nursery Setting: Feasibility Cluster and Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This programme of work aims to investigate the feasibility and acceptability to both children and nursery staff of offering vegetables to children at breakfast time at nursery. Research will be completed to assess the feasibility of undertaking a subsequent cluster randomised controlled trial (RCT) on this question.
Detailed Description:
Children are not eating a sufficient amount of fruit and vegetables to ensure optimal health and development. Interventions are needed to help increase fruit and vegetable intake from the early years of children's lives, to support the development of lifelong healthy eating habits and the acceptance of vegetables as an important element of a normal diet. Vegetables are often refused by young children due to their often-bitter tastes, and so efforts to increase children's intake of vegetables is a health priority. Vegetables are not commonly offered at breakfast time, which reduces the opportunities each day for vegetables to be part of children's routine diets. Therefore, it is important to understand whether children will be willing to eat - or at least try - vegetables when offered alongside a usual breakfast food (e.g., cereal or toast). Preschool children eat many meals in childcare settings therefore nurseries provide an ideal setting in which to test whether the addition of vegetables at breakfast is feasible and acceptable to both children and nursery staff. This research will recruit nurseries in the East Midlands, UK, to investigate whether children and nursery staff are willing and able to offer (and eat) vegetables at breakfast. The study will adopt a feasibility cluster randomised controlled trial design where nurseries will be randomly allocated to deliver the Veggie Brek intervention or usual breakfast every weekday for three weeks. There will be a baseline period and follow-up period of five days where vegetables will be offered to children at breakfast.
Data will also be collected to understand the nursery staff's views on the study and how easy/difficult the study's procedures were to implement (e.g., were instructions clear and could be followed, were there any barriers to offering vegetables at breakfast). This information will be used to inform the feasibility and acceptability of a later trial.
Data will also be collected to understand the nursery staff's views on the study and how easy/difficult the study's procedures were to implement (e.g., were instructions clear and could be followed, were there any barriers to offering vegetables at breakfast). This information will be used to inform the feasibility and acceptability of a later trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: