Testing the Veggie Brek Intervention

NCT05217550 | Completed

• 1 other identifier: Veggie Brek 1: F&A Cluster RCT
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention (Veggie Brek)

EXPERIMENTAL

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

Control

NO INTERVENTION

Children will be served their normal breakfast (with no vegetables) across the three-week intervention period.

Interventions

Veggie Brek BEHAVIORAL

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.

Intervention (Veggie Brek)

Eligibility Criteria

• Age: 18 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related Publications (1)

• McLeod CJ, Haycraft E, Daley AJ. Offering vegetables to children at breakfast time in nursery and kindergarten settings: the Veggie Brek feasibility and acceptability cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2023 Mar 28;20(1):38. doi: 10.1186/s12966-023-01443-z.

  PMID: 36978097 DERIVED

Study Officials

• Amanda Daley, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Behavioural Medicine

Model Details: Single-centre interventional cluster randomised controlled trial

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 1, 2022
• Study Start: October 18, 2021
• Primary Completion: February 18, 2022
• Study Completion: March 30, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Intention to publish date: 01/12/2023
• 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.

Locations

GB (1)