Condition category
Not Applicable
Date applied
04/04/2018
Date assigned
14/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Strategies to improve health behaviour and well-being of Danish children are needed.
A multicomponent intervention “We Act – together for health” has been developed with the aim to improve the dietary habits, physical activity, well-being and social capital among school children aged 10-12 years by increasing their health experiences and promoting a healthy school environment.

Who can participate?
Children aged 10-12 attending a participating school

What does the study involve?
Four schools participate in the intervention, matched with control schools from the same municipality.
The intervention is made up of an educational component, teaching meal habits and other processes within school. The school component provides a workshop to develop teachers’ competencies, and finally the parental component comprises a homepage, an APP, a Facebook-group and a handout produced by their child.
The intervention runs for 6 – 8 months, with data collected before and after by photograph, pedometer and questionnaire.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for the children participating in the We Act intervention. Hopefully they will enjoy teaching that builds on a democratic health education approach.

Where is the study run from?
Eight schools in Denmark

When is the study starting and how long is it expected to run for?
October 2014 to September 2017

Who is funding the study?
Nestlé Denmark A/S (Denmark)

Who is the main contact?
Mrs Marianne Sabinsky (Scientific)
masab@food.dtu.dk

Trial website

http://www.healthykids.food.dtu.dk/

Contact information

Type

Scientific

Primary contact

Mrs Marianne Sabinsky

ORCID ID

http://orcid.org/0000-0001-5738-2714

Contact details

Kemitorvet
Building 201
Room 106
Kgs. Lyngby
2800
Denmark
+45 35 88 71 05
masab@food.dtu.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H-7-2015-FSP1

Study information

Scientific title

“We Act – together for health” - a school-based multicomponent intervention to promote healthy diet, physical activity, and wellbeing in school children aged 10-12 years

Acronym

Study hypothesis

School children’s participation in health education following the IVAC model develops their action competence in health and this, along with support from teachers, school management and parents, initiates a change process creating a healthy supportive school environment, leading to an increase in nutrition quality and dietary intake, physical activity, social capital and wellbeing in school children.

Ethics approval

1. Danish Data Protection Agency, 18/04/2015, ref: 2015-41-4201
2. Regional Ethics Committee for the Capital Region of Denmark, 04/05/2015, ref: H-7-2015-FSP1

Study design

Quasi-experimental controlled pre- and post-intervention study

Primary study design

Interventional

Secondary study design

Quasi-experimental with controls

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

Health promotion

Intervention

The intervention builds upon the health promoting school approach and the IVAC model. The settings are the school and the family.
Four schools are recruited for the intervention, and matched with four control schools from the same municipality, considering families' social backgrounds and school size.
The intervention schools receive an intervention made up of three educational components:
1) Lunch meal habits are integrated into science and Danish (“IEAT”) and physical activity is integrated into maths (“IMOVE”)
2) Vision workshop is integrated primarily in Danish
3) The Action and Change process is taught at class and school level.
Teachers participate in a course to develop competencies regarding the holistic health concept, active involvement of school children and the IVAC approach. Components developed for parental support included a homepage, an APP, a Facebook-group and a handout produced by their child.
The intervention runs for about 6-8 months. The control schools receive no intervention at all, only the scientific measurements which are recorded at baseline and after the intervention.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Dietary intake (food groups) is measured using the digital photographic method
2. Physical activity is measured using a pedometer
3. Wellbeing is measured using the Personal Social Capital Scale questionnaire

All primary outcome measures are collected at baseline and again after the intervention.

Secondary outcome measures

Anthropometrics (Height and Weight) are measured at baseline and after the intervention.

Overall trial start date

01/10/2014

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. School does not have a school food programme
2. Sufficient number of children in 5th and 6th grade
3. School motivated to participate

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

4 intervention schools and 4 control schools, at least 75 children at each school

Participant exclusion criteria

1. Small school with too few children

Recruitment start date

01/03/2015

Recruitment end date

01/08/2015

Locations

Countries of recruitment

Denmark

Trial participating centre

National Food Institute, Technical University of Denmark
Kemitorvet Building 201, Room 106
Kgs. Lyngby
2800
Denmark

Trial participating centre

Steno Diabetes Center Copenhagen
Niels Steensens Vej 6
Gentofte
2820
Denmark

Sponsor information

Organisation

National Food Institute, Technical University of Denmark

Sponsor details

Kemitorvet
Kgs. Lyngby
2800
Denmark
+45 35 88 70 00
food@food.dtu.dk

Sponsor type

University/education

Website

http://www.food.dtu.dk/

Organisation

Steno Diabetes Center Copenhagen

Sponsor details

Niels Steensens Vej 6
Gentofte
2820
Denmark
+45 30 91 32 66
bjarne.bruun.jensen@regionh.dk

Sponsor type

Other

Website

http://www.steno.dk/

Funders

Funder type

Industry

Funder name

Nestlé Denmark A/S

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Food Institute, Technical University of Denmark

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Steno Diabetes Center Copenhagen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

15/04/2018: Protocol article: We Act – together for health” - a school-based multicomponent intervention to promote healthy diet, physical activity, and well-being in school children aged 10-12 years: a protocol for a quasi-experimental study
15/04/2018: Qualitative article: Children's agency in social capital and collective actions
15/05/2018: Process evaluation: Low Implementation Fidelity to the Action phase in the ‘We Act’ Health Promoting School Intervention – process evaluation results
30/05/2018: Effect on social capital: Building school-based social capital through ‘We Act - Together for Health’ – a quasi-experimental study
01/09/2018: Effect on food and physical activity: Effect of implementing “WeAct - together for health” a multicomponent school health intervention on quality of dietary intake and physical activity among children in 5th and 6th grade.

IPD sharing statement:
Data for this project will be held at internal databases at the DTU FOOD.

Intention to publish date

01/09/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes