Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/07/2017
Date assigned
13/09/2017
Last edited
09/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

https://www.uia.no/mattilminsten

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

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

uia.no

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

Publication citations

Additional files

Editorial Notes

09/04/2018: Recruitment end date was changed from 31/12/2017 to 31/01/2018.