Clinical trial NCT05217550: Testing the Veggie Brek Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre interventional cluster randomised controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's willingness to eat vegetables at breakfast as measured by counts of the vegetables eaten
timeFrame: End of week 5
measure: Nursery staff's ability to follow the protocol as measured by completion of the data collection sheets
timeFrame: End of week 5
measure: Recruitment rate
timeFrame: End of week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Amanda Daley, PhD
role: PRINCIPAL_INVESTIGATOR
References: