Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/02/2016
Date assigned
29/02/2016
Last edited
29/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The rate of childhood obesity represent a public health challenge. The early feeding environment is critical for establishing eating habits that may influence weight development and healthy growth in the long term. Interventions targeting parents have been called for, with the aim of encouraging and facilitating the development of healthy eating habits in children. The aim of this study is to promote healthy feeding practices in parents and healthy dietary habits in children from early childhood.

Who can participate?
Parents with children aged between 3 and 5 months.

What does the study involve?
Participants are randomly allocated into either the intervention group or the control group. When the child is six months old, the participants in the intervention group receive access to a website which provides information about good parental feeding practices, diet quality and how to make healthy and age-appropriate homemade baby food. They receive a new e-mail every month with a link to the website until the child is one year old. Participants in the control group do not have access to the website. They receive their usual treatment at the community child health centres.

What are the possible benefits and risks of participating?
The parents in the intervention group will have easy access to information about good feeding practices and children's nutrition in the weaning period. There are no risks or side effects of participating in the 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?
February 2015 to February 2021

Who is funding the study?
University of Agder (Norway)

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

Trial website

www.spedbarnsmat.no

Contact information

Type

Scientific

Primary contact

Mrs Christine Helle

ORCID ID

Contact details

University of Agder
Faculty of Sport and Health Sciences
PO Box 422
Kristiansand
4604
Norway
+47 (0)30142107
christine.helle@uia.no

Type

Scientific

Additional contact

Prof Nina Cecilie Øverby

ORCID ID

http://orcid.org/0000-0002-1871-041X

Contact details

University of Agder
Faculty of Sport and Health Sciences
PO Box 422
Kristiansand
4604
Norway
+47 (0)38141324
nina.c.overby@uia.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Early Food for Future Health: a randomised controlled trial evaluating the effect of an e-health intervention ("barnE-mat") in parents, aiming to promote healthy and sustainable food habits from early childhood

Acronym

Study hypothesis

An E-health intervention addressing early parental feeding practices will improve the children's diet quality , increase beneficial parental feeding practices and prevent future obesity.

Ethics approval

Norwegian Social Science Data Services, Data Protection Official for Research, 18/12/2015, Ref: 43975

Study design

Single-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

www.spedbarnsmat.no (in Norwegian)

Condition

Dietary habits in early childhood, parental feeding styles and practices and child obesity

Intervention

Upon completion of baseline measures, participants will be randomly assigned into either intervention or control group.

When the child is six months old, the participants in the intervention group will receive access to a website, which provide information relating to beneficial parental feeding practices, diet quality and how to make healthy and age-appropriate homemade baby food in the weaning period. The participants in the intervention group will receive a new e-mail every month with an age-dependent link to the website until the child is one year old. The intervention lasts for six months.

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.


Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Infant primary outcome measures:
1. Food intake and food variance: measured at 5, 13, 24 and 48 months by a Food Frequency Questionnaire developed for this study
2.Food preferences: measured at 13 months by a Food Preferences Questionnaire developed for this study, based on Wardle, Guthrie et al. 2001
3. Food neophobia: measured at 13, 24 and 48 months by The Child Food Neophobia Scale (Pliner & Hobden, 1992)
4. Eating behaviour: measured at 5 months by BEBQ; The Baby Eating Behaviour Questionnaire (Llewellyn, van Jaarsveld, Johnson, Carnell and Wardle 2011); measured at 13 months by CEBQ, The Child Eating behaviour Questionnaire (Wardle et.al. 2001)

Parent primary outcome measures:
1. Feeding style and feeding practices: measured at 5 and 13 months by The Infant Feeding Questionnaire (Baughcum et al. 2001)
2. Feeding self efficacy: measured at 6 and 12 months by The Feeding Self-efficacy scale (Horodynski & Stommel 2005)
3. Parenting style: measured at 5 and 13 months by The Infancy Parenting Styles Questionnaire (Arnott & Brown 2013)
4. Parenting style/control-oriented parenting: measured at 12 months by five items from The Parental Locus of Control Scale (Campis et al. 1986)
5. Making more homemade baby food in the weaning period: measured by a Frequency Questionnaire developed for this study

Secondary outcome measures

Infant secondary outcome measures:
1. Weight and height: measured at 5, 13, 24 and 48 months. Self-reported/measured at the scheduled visits to the child health centre
2. Child behaviour: internalizing and externalizing behaviour ( Jacka et al. 2013), measured by questions from The Child Behaviour Checklist Questionnaire at 24 and 48 months

Overall trial start date

01/02/2015

Overall trial end date

01/02/2021

Reason abandoned

Eligibility

Participant inclusion criteria

Mothers and fathers of children between the age of 3 and 5 months

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

We aim to include 500 children/parents in the control group and 500 children/parents in the intervention group

Participant exclusion criteria

1. Child born before gestation week 38 and with birth-weight less than 2500 g
2. Parents do not understand the Norwegian language

Recruitment start date

01/03/2016

Recruitment end date

01/09/2016

Locations

Countries of recruitment

Norway

Trial participating centre

University of Agder, Faculty of Sport and Health Sciences
PO Box 422
Kristiansand
N-4604
Norway

Sponsor information

Organisation

University of Agder (Norway)

Sponsor details

PO Box 422
Kristiansand
4604
Norway
+47 (0)381400
post@uia.no

Sponsor type

University/education

Website

www.uia.no

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Autumn 2016: Study protocol
2. Spring 2017: Effect of an E-health intervention on parental feeding practices
3. Autumn 2017: Effect of an E-health intervention on children’s food neophobia, dietary habits and weight status
4. Spring 2018: Associations between parent perceived child characteristics and child feeding behaviour; investigating the mediating role of an e-health intervention addressing food parenting

Intention to publish date

01/03/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes