Condition category
Not Applicable
Date applied
17/11/2014
Date assigned
08/01/2015
Last edited
28/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Energy balance is a term to describe the relationship between the amount of energy we take in (though our food and drink) and how much of that energy we use in our day-to-day activities. Our levels of physical activity, eating habits and how sedentary our life is are termed energy-balanced related behaviours (EBRBs) and they seem to vary according to socioeconomic differences (how wealthy we are and our social position). Here, we want to identify the most important factors influencing EBRBs among preschool children, taking into account their socioeconomic background (phase 1). In the second phase of our study, we then apply what we have learned from phase 1 and develop an intervention that aims to balance children’s EBRBs and diminish health socioeconomic inequalities.

Who can participate?
The study participants are recruited through preschools in Uusimaa region in Finland. Preschools are recruited based on their socioeconomic neighborhood (half in high and half in low socioeconomic neighborhoods in municipality). The neighborhoods are ranked into an order according to the statistics: the preschools belonging to the highest and lowest tertiaries are contacted. Eligible participants are 3-5 year old children in preschools and their parents.

What does the study involve?
The overall study is divided into two phases. The first phase includes both focus group interviews and a cross-sectional study in years 2014 and 2015. In the cross-sectional study, children are asked to wear a accelerometer for seven days and samples of their saliva and hair are taken. Parents and teachers fill in children’s food records and complete a questionnaire. The Heads of each preschool also complete a questionnaire. The second phase includes applying an intervention in preschools in years 2016 and 2017. The content of this intervention is based on what is learned in phase 1. At this stage, each preschool is randomly allocated into either the intervention group or the control group. Those preschools that are in the intervention group receive the intervention. Those preschools that are in the control group operate as usual. Assessments are performed in all the preschools before the intervention is introduced and after it has been completed. These include comparing the activity levels, dietary habits of all participating children.

What are the possible benefits and risks of participating?
Children and their parents receive feedback of children’s levels of activity. All the participating preschools receive guidebook of interventions after the follow-up measurements.

Where is the study run from?
Samfundet Folkhälsan, Folkhälsan Research Centre (Finland)

When is the study starting and how long is it expected to run for?
January 2014 to December 2019

Who is funding the study?
1. Samfundet Folkhälsan (Finland)
2. University of Helsinki (Finland)
3. Juho Vainio Foundation (Finland)
4. Gyllenberg Foundation (Finland)
5. Finnish ministry of Education and Culture (Finland)

Who is the main contact?
Dr Eva Roos
eva.roos@folkhalsan.fi

Trial website

https://dagisfh.wordpress.com/in-english/

Contact information

Type

Scientific

Primary contact

Dr Eva Roos

ORCID ID

http://orcid.org/0000-0003-3521-6517

Contact details

Folkhälsan Research Center
Topeliuksenkatu 20
00250 Helsinki
Finland
Helsinki
00250
Finland
_
eva.roos@folkhalsan.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

DAGIS Increased Health and Wellbeing in Preschools

Acronym

DAGIS

Study hypothesis

1. The hypotheses of cross-sectional survey with needs assessment:
1.1 The modifiable factors associated with children's energy-balance related behaviors (EBRBs) are recognized.
2. The hypotheses of environments intervention:
2.1. The multi-level intervention at preschool setting balances children's EBRBs.
2.2 The multi-level intervention at preschool setting diminishes socioeconomic differences in children's EBRBs.

Ethics approval

Ethics committee of the Hospital district of Helsinki and Uusimaa, 15/05/2014, ref: Dnro 112/13/03/00/14.

Study design

Two main phases:
1. Needs assessment study (focus group interviews and survey) in years 2014-2015
2. Randomized control trials in years 2016-2017

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet (sheets are in Finnish).

Condition

Sedentary time, eating habits, stress

Intervention

The content of intervention is based on the results of phase 1. Intervention group 1 receives multiple practices and methods to improve children's EBRBs. The baseline and follow-up measurements are assessed for both intervention and control groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Children: sedentary time measured by accelerometer, intake of fruits and vegetables and intake of sugar-enriched foods measured by dietary assessment methods, stress level measured by hair and saliva samples. The socioeconomic differences in EBRBs.

Secondary outcome measures

The most important modifiable factors of sedentariness, sugar-enriched food intake, and vegetable and fruit intake.

Overall trial start date

01/01/2014

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

For the randomized control trials:
1. Preschool situated either in high or low socioeconomic neighborhood in municipality
2. At least 30 percent of 3-5-year old children in the preschool group need to participate in order to conduct intervention

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600 children, aged 3-5 years, approximately 50 preschool groups (half in high and half in low socioeconomic neighborhoods)

Participant exclusion criteria

For the randomized control trials:
1. The preschool is not situated in high or low socioeconomic neighborhood in municipality.
2. Parents/guardians of children that do not sign informed consent

Recruitment start date

01/04/2015

Recruitment end date

31/10/2016

Locations

Countries of recruitment

Finland

Trial participating centre

Folkhälsan Research Center
Helsinki
00250
Finland

Sponsor information

Organisation

Samfundet Folkhälsan

Sponsor details

Samfundet Folkhälsan
Topeliuksenkatu 20
00250 Helsinki
Finland
Helsinki
00250
Finland
_
jaana.welin-haapamaki@helsinki.fi

Sponsor type

Not defined

Website

http://www.folkhalsan.fi

Funders

Funder type

Not defined

Funder name

Samfundet Folkhälsan (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Helsinki (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Juho Vainio Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gyllenberg Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Finnish ministry of Education and Culture (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Study protocol article in BMC Public Health spring 2015
2. The communication plan of this study includes the public and scientific parts of communication. Researchers will write several articles for peer-reviewed scientific journals. The articles will be published either in open access journals or will be provided through Researchgate. In addition to this, press releases will be published on the significant findings of the study. Additional articles will also be published in national journals to promote the results. The adjunct professors of the study group will present the results as part of their teaching at the University. The results will also be presented at several national and international congresses, workshops and other possible events that are meant for health promoters, researchers and policy-makers. The website for the project, the main channel for informing the current status of the study, was launched in the fall of 2014 (www.dagis.fi). It will be possible to download the final report and intervention material from the website after the project has ended and they will be freely available to everyone. The final report of the study will be published in a seminar organized at the end of the project in 2019. The final report will include the evaluation of the dissemination of the results in the scientific community and the general public. This evaluation is partly based on the numbers of scientific publications during the project. The results can be utilized by Finnish preschools and early education teaching sectors. The steering group of the study, to be established in 2015, will also help to spread the results to the relevant parties.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25927298

Publication citations

Additional files

Editorial Notes