Plain English Summary
Background and study aims
There is an increase in overweight/obesity and lifestyle diseases such as cancer, cardiovascular diseases and diabetes type 2. Increasing vegetable intake in children could help to prevent these diseases in later life. It has been found however, that neither children nor adults eat vegetables in accordance with the Norwegian dietary guidelines for the general population. Kindergartens are important health promoting arenas, especially in Norway since more than 90 % of 3-5 year-olds attend kindergarten. The aim of this study is to design, conduct and evaluate an program aiming to increase the vegetable intake of 3-5 year old through improving the availability of vegetables and practices around serving these vegetables in the kindergartens and homes.
Who can participate?
Public and private kindergartens in the counties of Vestfold and Buskerud (Norway), all children attending who were born in 2010 or 2011 and their parents.
What does the study involve?
Kindergartens are randomly allocated to one of two groups. In the first group, Kindergarten staff attend an "inspirational day", which involves practical kitchen training and how to involve children, as well as information about how to encourage children to eat and taste vegetables. At the end of the day, staff receive material to take back to the kindergarten and the parents to help them make the changes that are needed. The material consists of aprons, booklets, mixers, posters, brochures. All written material and additional information is also made available through a website, and both staff and parents could become members of a Facebook group. The main messages are that children should eat approximately 180 grams of vegetables a day and so should be offered vegetables 3-4 times per day and the vegetables offered should vary over the week/month. Those in the second group continue as normal for the duration of the study. Participants in both groups are followed up after one and two years in order to find out if the children's vegetable intake has changed.
What are the possible benefits and risks of participating?
The kindergartens and parents who takepart in the program benefit from having access to information about nutrition, as well as receiving material resources and social support to promote vegetable intake of the children. The main risk is that vegetable intake is just replacing the fruit intake and thus there are no additional health benefits through an increased intake of vegetables. An additional risk is if the staff or parents do not acquire the skills to apply the good practices, but instead forces the children to taste/eat vegetables, which could cause distress to the children.
Where is the study run from?
The study is run from the Department of Nutrition at the University of Oslowas and takes place in nursery schools in Vestfold and Buskerud (Norway)
When is the study starting and how long is it expected to run for?
December 2013 to November 2017
Who is funding the study?
1. Norwegian Research Council (Norway)
2. Throne Holst Nutrition Research Foundation (Norway)
3. Norwegian Fruit and Vegetable Information Bureau (Norway)
Who is the main contact?
Professor Nanna Lien
nanna.lien@medisin.uio.no
Trial website
Contact information
Type
Scientific
Primary contact
Prof Nanna Lien
ORCID ID
Contact details
University of Oslo
Institute for Basic Medical Sciences
P.O. Box 1046
Bilndern
Oslo
0316
Norway
+47 22 85 13 78
nanna.lien@medisin.uio.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
228452
Study information
Scientific title
Promoting vegetable consumption among 3-5 year olds through an intervention targeting the kindergarten and home environments
Acronym
The BRA-study
Study hypothesis
An intervention targeting the availability, accessability, role modelling and encouragement to taste/eat vegetables in kindergarten and home will lead to an increased intake (frequency, variation and amount) of vegetables among 3-5 year olds.
Ethics approval
Norwegian Centre for Research Data, 13/11/2014, ref: 40383
Study design
Unblinded cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Healthy eating
Intervention
Kindergartens are randomly allocated to one of two groups by an independent statistician using a method and software script to ensure an even distribution of public and private kindergarten as well as children in the intervention and control groups.
Control group: Kindergartens continue as usual for the duration of the study. They are offered the revised intervention material after the trial.
Intervention group: The intervention consists of an inspirational day offered to staff in the Kindergarten (Sept 2015). The day consists of a practical session in the kitchen focusing on skills and involvement of children, and a theoretical session on how to change availability, accessability, role modelling and encouragement to taste/eat vegetables. At the end of the day, staff receive material to take back to the kindergarten and the parents to help them implement the changes needed. The material consists of aprons, booklets, mixers, posters, brochures. All written material and additional information is also made available through a website, and both staff and parents could become members of a Facebook group. Follow-up activities for both staff and parents are sent out by e-mail or post to the kindergarten in November (2015) and February (2016).
The first follow-up (one year) activities consists of a registration of 3 days of vegetables served in the kindergarten/at home, as well as ideas for taste games and information and recipes with different types of cabbage. Kindergartens/parents returning their 3 day registration take part in a drawing for gift cards. The second follow-up (two years) focuses on spring vegetables with recipes and information about how to grow them for the kindergarten staff, and activities for parents to do with their children targeting availability, accessibility, role modelling or encouragement of vegetable intake at home.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Frequency and variation of vegetable intake in children is measured by internet-based questionnaires completed by parents at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
2. Amount of vegetables consumed by children is measured using an internet-based 24 hour recall where parents report the amounts of vegetables that the child ate the day before at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
3. Vegetable intake during the day in the kindergarten in a sub-sample of children is measured through observations by trained project workers on the same day as the 24 hour recall at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
Secondary outcome measures
1. Availability of vegetables in the kindergarten is measured by a questionnaire (frequency and variation) and a weighed 1-week diary at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
2. Practices of kindergarten staff related to the offering of vegetables to the children in the kindergarten is measured using a questionnaire designed for the purpose of this study at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
3. Practices of parents related to the offering of vegetables to the children at home is measured using an internet-based questionnaire designed for the purpose of this study at baseline (Spring 2015), year 1 (Spring 2016) and year 2 (Spring 2017)
Overall trial start date
01/12/2013
Overall trial end date
30/11/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Kindergartens:
Public or private kindergartens with at least 10 children attending who were born in 2010 or 2011
Children:
Born in 2010 or 2011
Parents:
1. Able to read and write Norwegian
2. Have internet access
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
900 children, 900 parents, 4 staff per kindergarten in 90 kindergartens. Total: 2136
Total final enrolment
1266
Participant exclusion criteria
Kindergartens
Family based
Children:
Those older or younger than those born in 2010/2011
Parents
1. Insufficient skills in Norwegian
2. Without internet access
Recruitment start date
01/12/2014
Recruitment end date
01/03/2015
Locations
Countries of recruitment
Norway
Trial participating centre
Department of Nutrition, University of Oslo
P.O.Box 1046
Oslo
0316
Norway
Sponsor information
Organisation
University of Oslo
Sponsor details
Institute for Basic Medical Sciences
P.O. Box 1110.
Bilndern
Oslo
0317
Norway
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Research Council of Norway (Norges Forskningsråd)
Alternative name(s)
Research Council of Norway, Forskningsrådet, Norwegian Research Council
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Norway
Funder name
Throne Holst Nutrition Research Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norwegian Fruit and Vegetable Information Bureau
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
There will be at least 6 peer-reviewed papers of which two on the effects based on this study and they are planned to be published in the period 2016-2018.
Intention to publish date
31/12/2016
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31409342 (added 15/08/2019)
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31937362 (added 16/01/2020)