ISRCTN - ISRCTN45864056: First food for infants

Plain English Summary

Background and study aims
Although many parents try to ensure that their children have a healthy and balanced diet, it is not always the case. Cooking skills, time spent on cooking and intake of homemade food have all decreased in recent years, leading to lack of diversity in some children’s diets. Some researchers suggest that the lack of cooking skills, lack of diversity in the diet and the replacement of fruit and vegetables with unhealthy processed food may be a factor contributing to the increase in childhood obesity. "First food for infants" is a new program aiming to provide new knowledge on how to promote a healthy and varied diet among infants by improving parental cooking skills and knowledge. The aim of this knowledge is to find out whether this program can help to improve infant diet, improve parental cooking skills, and to promote a healthy cholesterol and vitamin D-status in children.

Who can participate?
Parents of children aged 5-6 months old who attend public health clinics in Kristiansand and Arendal, Norway.

What does the study involve?
Participants are randomly allocated to one of two groups. Parents in the first group take part in a two day cooking course to learn about how to prepare a variety of baby food and to improve general cooking skills. The course involves learning about important foods for infants, as well as learning how to make fruit purées, porridges, breads, and nutritious toppings and dinner meals, such as vegetable purées and chicken and tuna bowls with pea purée. At the sessions, parents are encouraged to have their infant try as many new foods as possible. Those in the second group are given a brochure containing recipes for homemade foods for infants only. All parents fill in a number of questionnaires at the start of the study (6 months of age), and when the infant is 15 and 24 months of age, to measure the food intake of their infant and their own cooking skills and knowledge. A finger prick blood test is taken from the infants at 15 and 24 months of age in order to measure the cholesterol and vitamin D levels.

What are the possible benefits and risks of participating?
Participants may benefit from imp[roved cooking skills (parents) and improved diet, growth and cholesterol levels (children). There are no notable risks involved with taking part 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?
October 2011 to September 2015

Who is funding the study?
Norwegian Women's Public Health Association (Norway)

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

Trial website

http://old.uia.no/div/prosjekt/mat_for_smaa_mager

Contact information

Type

Scientific

Primary contact

Prof Nina Cecilie Øverby

ORCID ID

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

Contact details

University of Agder
Faculty of Health and Sport Sciences
PO 422
Kristiansand
N-4604
Norway
+4738141324
nina.c.overby@uia.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled trial evaluating a cooking intervention to improve parental cooking skills and thereby improve dietary intake in infants aged 6- 12 months

Acronym

Study hypothesis

Children in the intervention group will have a more healthy and varied diet, a better lipid profile and vitamin D status, have healthier growth curves and have parents with better cooking skills and knowledge than those in the control group.

Ethics approval

Starting the study was recommended started by the Norwegian Social Science Data Service 12.06.2012. Previous to that, the study was submitted to the Regional Ethics Committees, however since they did not find that the project was within the Health Research Law, and recommended it submitted to the Norwegian Social Science Data Service.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Available in Norweigen via http://old.uia.no/div/prosjekt/mat_for_smaa_mager/informasjon

Condition

Nutritional intake

Intervention

Participants are randomly allocated to one of two groups.

Control group: Parents receive a booklet containing recipes for homemade foods for infants and are not given access to the practical courses or the recipes presented there.

Intervention group: The intervention group is invited to a two-day-course including some theory of infant nutrition, and a main focus on increasing practical food cooking skills (i.e. how to prepare and cook the first food for infants). They are also taught how to store food and how to be confident in making infants’ food themselves. Five groups of participants attend the course on two different days. Each of the two course days lasts four hours, and parents are given theoretical knowledge about the infants first food as well as practical knowledge on how to make nutritious and varied food.
The first course day focuses on the introduction of the first solid food for infants. The theory refers to regular meals, using water when child is thirsty, iron-rich food, nutritious fruit purées, porridges, bread and toppings. The participants are informed about the importance of letting infants taste many new food items before the age of two, to avoid food neophobia and picky eating. The participants then make various kinds of fruit purées, porridges, breads, and nutritious toppings. They produced fruit purées of fresh fruit and berries as raspberries, blackcurrant, pears, apples, apricots (without preservatives), prunes and nectarines, according to season and time of the year, and porridges from millet, oats, spelt and whole wheat flour. They also produce home-made porridge powder from millet bread for travelling. They taste homemade bread and various toppings as broccoli, salmon, humus and roast beef with chickpeas.
On the second course day, nutritious dinner meals were in focus. Participants make purées of carrots, potatoes, broccoli, cauliflower, avocado and rutabaga. They also make purées of vegetables with tomatoes and cheese, as well as chicken and tuna bowls with pea purée. The participants let their infants taste as many various new vegetables as possible.

All participants fill in questionnaires at baseline (6 months of age), and at 15 and 24 months of age. A finger blood test was taken of the infants at 15 and 24 months of age.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Food intake is measured using food frequency questionnaires when infants are 6 (baseline), 15 and 24 months of age

Secondary outcome measures

1. Levels of HDL, LDL and total cholesterol and vitamin D are measured using finger stick blood tests at when infants are 15 and 24 months of age
2. Parental cooking skills and knowledge is measured using questionnaires when infants are 6 (baseline), 15 and 24 months of age
3. Child growth from 6 to 24 months of age is measured using self reported weight and height when infants are 6 (baseline), 15 and 24 months of age

Overall trial start date

01/10/2011

Overall trial end date

01/09/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Children inclusion criteria:
Children aged 5-6 months, attending the selected public health clinics.

Parent inclusion criteria:
Having child aged 5-6 months attending the selected public health clinic

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

160

Total final enrolment

110

Participant exclusion criteria

Not meeting inclusion criteria

Recruitment start date

20/06/2012

Recruitment end date

19/12/2014

Locations

Countries of recruitment

Norway

Trial participating centre

University of Agder
Gimlemoen 25
Kristiansand
4630
Norway

Sponsor information

Organisation

University of Agder

Sponsor details

Gimlemoen 25
Kristiansand
4630
Norway
+47 38 10 00
post@uia.no

Sponsor type

University/education

Website

http://www.uia.no/

Funders

Funder type

Charity

Funder name

Norwegian Women's Public Health Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of three papers in peer reviewed journals:
1. Effect of cooking intervention on young children’s lipid and vitamin D status
2. Effect of cooking intervention on child food intake and parental cooking skills
3. Effect of cooking intervention on child growth