Testing the Veggie Brek Intervention

Veggie Brek: The Feasibility and Acceptability of Offering Vegetables to Children at Breakfast Time in a Nursery Setting: Feasibility Cluster and Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Behavioral: Veggie Brek

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.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE11 3TU
      • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Located in the East Midlands and surrounding areas.

Children:

• Aged 18 months - 4 years.
• Weaned onto solid foods and able to self-feed.
• Eat breakfast at their nursery at least one day a week.

Exclusion Criteria:

• Children with any allergies or intolerances to raw carrot or raw cucumber, or with any conditions which impact feeding or eating in relation to this study (i.e., the offering of raw carrots and cucumber to children in a nursery setting) are not able to take part.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention (Veggie Brek); Nursery staff will present vegetables (raw carrot and cucumber batons) to children alongside their main breakfast food for five consecutive days every weekday morning for three weeks.	Behavioral: Veggie Brek; Offering vegetables to children at breakfast alongside their main breakfast food for three consecutive weeks (five days a week) between baseline and follow-up weeks where vegetables are also offered to children at breakfast alongside their main breakfast food for five days a week.
NO_INTERVENTION: Control; Children will be served their normal breakfast (with no vegetables) across the three-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's willingness to eat vegetables at breakfast as measured by counts of the vegetables eaten	The primary outcome is the feasibility and acceptability of the Veggie Brek study intervention which includes an assessment of children's willingness to eat vegetables at breakfast.	End of week 5
Nursery staff's ability to follow the protocol as measured by completion of the data collection sheets	The primary outcome is the feasibility and acceptability of the Veggie Brek study intervention which includes an assessment of nursery staff's ability to follow the study protocol.	End of week 5
Recruitment rate	The primary outcome is the feasibility and acceptability of the Veggie Brek study intervention which includes an assessment of the recruitment rate (i.e., parents who provide consent for their child to participate in the study).	End of week 5

Collaborators and Investigators

• Sponsor: Loughborough University
• Investigators: Principal Investigator: Amanda Daley, PhD, Loughborough University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2021
• Primary Completion (ACTUAL): February 18, 2022
• Study Completion (ACTUAL): March 30, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (ACTUAL): February 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Veggie Brek 1: F&A Cluster RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available upon request once the study findings have been published.
• IPD Sharing Time Frame: Intention to publish date: 01/12/2023
• IPD Sharing Access Criteria: Anonymous data will be shared with all who request access via email for novel analyses or re-analysis of the study outcomes. This will be administered by Dr Chris McLeod.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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