Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/05/2017
Date assigned
23/05/2017
Last edited
19/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A child’s first years of life are crucial for cognitive (mental) development and future health. Studies show that a varied diet with a high intake of vegetables is positive for weight development, mental health and cognitive development. A low intake of vegetables is considered one of the greatest challenges in children’s diets in Norway. Researchers suggest that one barrier for vegetable intake among children is food neophobia. Food neophobia is defined as a reluctance to taste and eat new foods. Food neophobia increases from the age of 2 years and decreases later in childhood. Interventions that can increase children’s intake of vegetables should be introduced early in life to overcome children’s neophobia. The aim of this study is to develop and measure the effect of two different interventions for one-year-old children in kindergartens to reduce food neophobia and promote healthy diets.

Who can participate?
Children born in 2016 attending kindergartens in the counties of Oppland and Telemark in Norway

What does the study involve?
The participating kindergartens are randomly allocated to one of three groups: two different intervention groups and one control group. The first intervention group are served a warm lunch meal with a variety of vegetables on three days a week during the 3-month study period. The second intervention group are served the same meals and also give lessons and advice on meal and feeding practices. Questionnaires, information videos and recipes are included on a study web page. The control group continue their usual meal practices. To measure the effect of the interventions, parents and kindergarten staff complete questionnaires at the start of the study and after the intervention. Food neophobia, diet, food variety, vegetable liking, cognitive development, parent and kindergarten staff feeding practices, and child weight and height are all recorded. There are follow-up-questionnaires when the children are 36 and 48 months old.

What are the possible benefits and risks of participating?
The results of this study will provide new knowledge about whether or not education and a healthy meal intervention targeting children, kindergarten staff and parents will reduce levels of food neophobia in toddlers, improve parental and kindergarten feeding practices, improve children’s dietary variety, improve children’s cognitive development and reduce childhood obesity. Kindergartens in the intervention groups will increase their knowledge and competence when it comes to food and meal serving. There are no risks of participating in this study.

Where is the study run from?
University of Agder (Norway)

When is the study starting and how long is it expected to run for?
August 2016 to August 2021

Who is funding the study?
1. Norske Kvinners Sanitetsforening (Norway)
2. University of Agder (Norway)

Who is the main contact?
Prof. Nina Øverby
nina.c.overby@uia.no

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nina Cecilie Øverby

ORCID ID

Contact details

University of Agder
Faculty of Sport and Health Sciences
PO Box 422
Kristiansand
4604
Norway
+47 (0)38 14 13 24
nina.c.overby@uia.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomized web-based intervention trial among one-year-old-children in kindergarten to reduce food neophobia and promote healthy diets

Acronym

Study hypothesis

A web-based intervention that gives specific pedagogical tools and instructions to serve warm meals with a variety of vegetables aimed at one-year-old children, kindergarten personnel and parents will:
1. Reduce the children's level of food neophobia
2. Increase the children's vegetable intake
3. Improve the children's cognitive development
4. Prevent future obesity
There are two different intervention groups, and the trialists hypothesize that the group with both pedagogical tools and instructions to serve warm meals will be more effective regarding the hypotheses than the intervention group with only instructions are to serve warm meals with different vegetables.

Ethics approval

Norwegian centre for research data (NSD), 21/10/2016, ref: 49951

Study design

Single-center interventional cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Participant information will be distributed by email and on the study webpage that will be password protected. Please use contact details to request the participant information sheets. The participant information sheets are only available in Norwegian.

Condition

Dietary habits, food neophobia, cognitive development, child obesity and parental and kindergarten personnel feeding practices

Intervention

The kindergartens will be randomly, consecutively allocated to either one of the intervention groups or control group based on a computer-generated list:
1. Intervention group 1 will be asked to serve a warm lunch meal with a variety of vegetables three days a week during the intervention period which will last for 3 months
2. Intervention group 2 will be asked to use given pedagogical tools including sensory lessons (the Sapere method) and advice on meal practice and feeding styles, in addition to serving the same meals as intervention group 1
3. The third group will be the control group and continue their usual practices

All the information given to the intervention groups, i.e. information videos, recipes and other necessary information, will be found in a study web page.

To evaluate effect of the interventions on the given outcomes, parents and kindergarten personnel will fill in questionnaires at baseline and post intervention. Questionnaires will be distributed by e-mail. There will be follow-up-questionnaires when the children are 36 and 48 months old.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Child vegetable intake, assessed at baseline, after the intervention, and at the ages 36 and 48 months
2. Children's level of food neophobia, assessed at baseline, after the intervention, and at the ages of 36 and 48 months
3. Child dietary habits and food variety, assessed at baseline, after the intervention, and at the ages of 36 and 48 months
All primary outcomes are measured using detailed questionnaires developed for this specific study.

Secondary outcome measures

1. Child cognitive development, assessed with the questionnaire Ages and Stages at baseline, after the intervention, and at the ages of 36 and 48 months
2. Weight and height, assessed by self-report at baseline and at the ages of 36 and 48 months
3. Parental and kindergarten staff feeding practices and role modeling, assessed with the Comprehensive Feeding Practices Questionnaire at baseline, after the intervention, and at the ages of 36 and 48 months

Overall trial start date

01/08/2016

Overall trial end date

01/08/2021

Reason abandoned

Eligibility

Participant inclusion criteria

Children born in the year of 2016 attending kindergartens in the counties of Oppland and Telemark in Norway

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

306 children

Participant exclusion criteria

Children whose parents does not understand written Norwegian language

Recruitment start date

15/08/2017

Recruitment end date

01/11/2017

Locations

Countries of recruitment

Norway

Trial participating centre

University of Agder
PO Box 422
Kristiansand
4604
Norway

Sponsor information

Organisation

University of Agder

Sponsor details

PO Box 422
Kristiansand
4604
Norway
+ 47 (0)38 14 10 00
post@uia.no

Sponsor type

University/education

Website

www.uia.no

Funders

Funder type

Charity

Funder name

Norske Kvinners Sanitetsforening

Alternative name(s)

Norwegian Women's Public Health Association, NKS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Norway

Funder name

University of Agder

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Autumn 2017/winter 2018: study protocol
2. Autumn 2018, winter 2019 and spring 2019:
2.1. Effect of two different dietary interventions on child food neophobia, vegetable intake and food variety
2.2. Effect of two different dietary interventions on child cognitive development
2.3. Effect of two different dietary interventions on parental and child care personnel feeding practices
3. Autumn 2019: Evaluation and perceived cost -effectiveness of two healthy diet intervention to increase one-year-olds intake of vegetables and food variety and reduction in food neophobia. A qualitative study

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Nina Øverby (nina.c.overby@uia.no).

Intention to publish date

01/09/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes