Plain English Summary
Background and study aims
The aim of this study is to develop and assess the effect of an e-health intervention, Food4toddlers ("Mat til Minsten" in Norwegian), that aims to promote healthy dietary habits in toddlers by targeting parents’ awareness of their child’s food and eating environment.
Who can participate?
Children aged from 12 to 18 months and their parents
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The intervention group get access to the Food4toddlers website for 6 months with weekly updates. Participants in the control group receive their usual treatment at community child health centres and do not have access to the website. The intervention group and the control group fill in surveys before and after the intervention. The child’s diet and self-feeding skills and the parents’ feeding practice, food planning skills and shopping behaviour are all assessed.
What are the possible benefits and risks of participating?
Benefits of participating in the intervention group include being updated on information regarding healthy food and eating environment, and the possibility of improving child diet and health. There are no risks related to participating.
Where is the study run from?
University of Agder (Norway)
When is the study starting and how long is it expected to run for?
March 2015 to June 2022
Who is funding the study?
University of Agder (Norway)
Who is the main contact?
1. Mrs Margrethe Røed
2. Prof. Nina Cecilie Øverby
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Margrethe Røed
ORCID ID
Contact details
Box 422
Kristiansand
4604
Norway
Type
Scientific
Additional contact
Prof Nina Cecilie Øverby
ORCID ID
http://orcid.org/0000-0002-1871-041X
Contact details
Box 422
Kristiansand
4604
Norway
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Project number from NSD: 48643
Study information
Scientific title
Fostering healthy dietary habits through a mobile-health intervention targeting toddlers' food and eating environment: a randomized controlled trial
Acronym
Food4toddlers
Study hypothesis
The intervention children compared to the control children:
1. Will have a more healthy and varied diet at ages 18, 24 and 48 months
2. Will have parents who are more responsive in their feeding practice
3. Will have more frequent planned and shared family meals, and less frequent meal distractions
4. Will have parents who are more aware of the food environment and make healthier choices at both in the grocery and at home
5. Will have healthier growth trajectory at ages 18, 24 and 48 months
6. Differences in diet between children with parents of low SES compared to high SES will be smaller in the intervention compared to control group
Ethics approval
Norwegian Centre for Research Data, 29/06/2017, ref: 48643
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Prevention
Patient information sheet
The participant information sheet is in Norwegian and is accessible from www.uia.no/mattilminsten
Condition
Healthy dietary habits and long-term health and wellbeing
Intervention
The overall objective of this study is to develop, implement, and evaluate the effect of a e-health intervention, Food4toddlers, that aims to promote healthy dietary habits in toddlers through targeting parental awareness of child food and eating environment. The participants will be randomised to either the control or the intervention group based on a computer-generated list of 500. Participants will be randomized consecutively, based on the time of completion of the first questionnaire. The intervention group get access to the website for 6 months, with weekly updates. The information given on the website relates to healthy food and eating environment (including choices made in grocery shopping). Participants in the control group will receive their usual treatment at the community child health centres, and do not have access to the web intervention. Among the participants in the control group three participants will be selected who will receive a reward. The intervention group and the control group answer surveys before and after the intervention.
The intervention will run when the child is from 12 to 18 months and measurements will be performed at ages 12, 18, 24 and 48 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Child diet quality and food variety, assessed using food frequency questions regarding core- and non-core food at inclusion, 18, 24, and 48 months
Secondary outcome measures
1. Eating environment (two levels):
1.1. Parental feeding practices (under/over-eating, hunger, infant cues, feeding attitudes, practices, perceptions/concern regarding weight), assessed using closed form survey at inclusion, 18, 24, and 48 months
1.2. Family meal setting (frequency of meals, meal distractions), assessed using closed form survey at inclusion, 18, 24, and 48 months
2. Food environment (two levels):
2.1. Food choice and awareness of food environment (planning, doing groceries, what influences food choice), assessed using closed form survey at inclusion, 18, 24, and 48 months
2.2. Availability and visibility of food in the home (availability and visibility of non-core and core foods), assessed using closed form survey at inclusion, 18, 24, and 48 months
3. Food preparation and planning, assessed using closed form survey at inclusion, 18, 24, and 48 months
4. Weight and length assessed using closed form survey at inclusion, 18, 24, and 48 months
Overall trial start date
01/03/2015
Overall trial end date
30/06/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged from 12 to 18 months during the intervention period
2. Parents of these children
Participant type
All
Age group
Mixed
Gender
Both
Target number of participants
500 children with parents
Total final enrolment
148
Participant exclusion criteria
Parents who cannot speak and write Norwegian
Recruitment start date
15/08/2017
Recruitment end date
31/01/2018
Locations
Countries of recruitment
Norway
Trial participating centre
University of Agder
Boks 422
Kristiansand
-
Norway
Sponsor information
Organisation
University of Agder
Sponsor details
Box 422
Kristiansand
4604
Norway
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Agder
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The protocol will be published and made available, however it is not submitted yet. A statistical plan will be included in the protocol.
Proposed scientific papers:
Paper 1: An intervention targeting toddlers’ food and eating environment: Effects on toddlers overall diet, food variety and self-feeding skills
Paper 2: An intervention targeting toddlers’ food and eating environment: Effects on toddlers’ food preferences and parent’s feeding style, feeding practices and meal distractions
Paper 3 : An intervention targeting toddlers food and eating environment: Effect on parental awareness of food environment at micro and macrolevel (home and food grocery store)
Paper 4 (parents SES): Differences in dietary behaviour between children with parents of low SES compared to high SES: Effects of an interventions targeting toddlers food and eating environment
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
20/12/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32628612/ (added 08/07/2020)