Increased Health and Wellbeing in Preschools

ISRCTN	ISRCTN57165350
DOI	https://doi.org/10.1186/ISRCTN57165350
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Samfundet Folkhälsan
Funders	Samfundet Folkhälsan (Finland), University of Helsinki (Finland), Juho Vainio Foundation (Finland), Gyllenberg Foundation (Finland), Finnish ministry of Education and Culture (Finland), Academy of Finland (Finland)

Submission date: 17/11/2014
Registration date: 08/01/2015
Last edited: 07/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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. In the third phase we will follow up the same children to examine whether early childhood environmental and individual factors (e.g., health behaviors) predict later EBRBs and weight, SR skills, recovery and learning outcomes in a longitudinal design.

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 three 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. In the third phase, the same children are followed up six years following the initial intervention. Data is collected in schools and at home. Children wear an accelerometer for seven days and a Firstbeat meter measuring heart rate variability and recovery from stress. Children and parents complete questionnaires assessing dietary habits, physical activity and sedentary habits and wellbeing.

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. Children and parents receive feedback on children’s level of activity, sedentary time and dietary and schools receive feedback at group level in the follow up.

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 2024

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)
5. Academy of Finland (Finland)

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

Contact information

Dr Eva Roos
Scientific

Folkhälsan Research Center
Topeliuksenkatu 20
00250 Helsinki
Finland
Helsinki
00250
Finland

ORCID ID	0000-0003-3521-6517
Phone	_
Email	eva.roos@folkhalsan.fi

Study information

Primary study design	Interventional
Study design	1. Needs assessment study (focus group interviews and survey) in years 2014-2015 2. Randomized control trials in years 2016-2017 (added 16/10/2024) 3. Follow-up study of 2016-2017 DAGIS randomized control trial in years 2023-2024
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	DAGIS Increased Health and Wellbeing in Preschools
Study acronym	DAGIS
Study objectives	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. (added 16/10/2024) 3. The hypotheses of follow-up study: 3.1. Early childhood environmental and individual factors (e.g., health behaviors) predict later EBRBs and weight, SR skills, recovery and learning outcomes in a longitudinal design.
Ethics approval(s)	Ethics committee of the Hospital district of Helsinki and Uusimaa, 15/05/2014, ref: Dnro 112/13/03/00/14. The DAGIS randomized control trial in years 2016-2017 obtained ethical approval from the University of Helsinki Ethical Review Board in the Humanities and Social and Behavioural Sciences (statement 22/2017). The DAGIS follow-up study obtained ethical approval from the University of Helsinki Ethical Review Board in the Humanities and Social and Behavioural Sciences (statement 46/2023).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Current primary outcome measure as of 16/10/2024: 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 and via heart rate variability. The socioeconomic differences in EBRBs. _____ Previous primary outcome measure: 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.
Key secondary outcome measure(s)	Current secondary outcome measures as of 16/10/2024: The most important modifiable factors of sedentariness, sugar-enriched food intake, and vegetable and fruit intake. The most important modifiable factors of weight. _____ Previous secondary outcome measures: The most important modifiable factors of sedentariness, sugar-enriched food intake, and vegetable and fruit intake.
Completion date	31/12/2024

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	5 Years
Sex	All
Target sample size at registration	600
Total final enrolment	864
Key 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 (added 16/10/2024) For the follow-up study: 1. Participants aged 8-12-years in primary schools (grades 3-6) in the same municipality as the randomized control trial.
Key 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 (added 16/10/2024) For the follow-up study: Children that do not sign informed consent or parents/guardians of children that do not sign informed consent.
Date of first enrolment	01/04/2015
Date of final enrolment	31/10/2016

Locations

Countries of recruitment

Finland

Study participating centre

Folkhälsan Research Center

Helsinki
00250
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/11/2017	26/02/2021	Yes	No
Results article	results	12/12/2019	26/02/2021	Yes	No
Results article		05/12/2022	06/12/2022	Yes	No
Results article		04/11/2020	14/02/2024	Yes	No
Results article		26/08/2020	14/02/2024	Yes	No
Results article		06/11/2025	07/11/2025	Yes	No
Protocol article	protocol	18/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/11/2025: Publication reference added.
16/10/2024: The following changes were made to the trial record to add a follow up study:
1. The study hypothesis was updated.
2. The ethics approval was updated.
3. The study design was updated.
4. The overall end date was changed from 31/12/2019 to 31/12/2024.
5. The primary outcome measure was changed.
6. The secondary outcome measures were changed.
7. The inclusion criteria were updated.
8. The exclusion criteria were updated.
9. The plain English summary was updated to reflect these changes.
10. The funder Academy of Finland (Finland) was added.
14/02/2024: Publication references added.
06/12/2022: Publication reference added.
26/02/2021: Publication references added.