Nutrition, HealthyNCT05217550
Testing the Veggie Brek Intervention
A study testing Veggie Brek in people with Nutrition, Healthy, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Veggie Brek
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
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
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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Veggie Brek
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veggie BrekBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Veggie Brek |
| Control | No intervention | Children will be served their normal breakfast (with no vegetables) across the three-week intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: End of week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start18 Oct 2021
- Primary completion18 Feb 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre interventional cluster randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Daley, Loughborough University
- Investigators
- Amanda Daley, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217550
- Sponsor's protocol ID
- Veggie Brek 1: F&A Cluster RCT
- Status last verified
- May 2022
- First submitted
- 16 Dec 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request once the study findings have been published.
Publications
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.
PubMed 36978097
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05217550
- Acronym / sponsor ID
- Veggie Brek 1: F&A Cluster RCT
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre interventional cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention (Veggie Brek) | Experimental | Behavioral: Veggie BrekNursery 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. |
| Control | No intervention | –Children will be served their normal breakfast (with no vegetables) across the three-week intervention period. |
Who may qualify
- Ages
- 18 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Located in the East Midlands and surrounding areas.
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veggie BrekOffering 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. | Behavioural | Intervention (Veggie Brek) |
Primary outcome
Children's willingness to eat vegetables at breakfast as measured by counts of the vegetables eaten
Time frame: End of week 5
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.
Nursery staff's ability to follow the protocol as measured by completion of the data collection sheets
Time frame: End of week 5
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.
Recruitment rate
Time frame: End of week 5
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 36978097McLeod 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.
- Individual participant dataSharing planned: Yes. Available upon request once the study findings have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Daley, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veggie Brek in people with Nutrition, Healthy, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's willingness to eat vegetables at breakfast as measured by counts of the vegetables eaten (time frame: End of week 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.