Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
NCT ID: NCT05940675
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1372 participants
INTERVENTIONAL
2023-08-14
2025-06-30
Brief Summary
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The GHK main trial is a two-school-year cluster-randomized school- and community trial designed to investigate the effect of the multi-setting, multi-component GHK intervention program on weight development, health and wellbeing in Danish children aged 6-11 years. The trial will include 24 schools in Denmark (12 intervention and 12 control).
The primary aim of the cluster-randomized trial is to investigate whether the GHK intervention program can promote healthy body composition as measured by fat mass (FM) in the intervention group compared with the control group. We hypothesize that the intervention will result in less FM gain in the intervention group compared with the control group over the two school-year study period.
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Detailed Description
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In continuation of the above, we will investigate if the intervention can reduce social inequality in the outcomes, as well as explore potential effect modifiers such as sex, ethnicity, implementation levels, genetics, epigenetics etc. We will also explore associations between sociodemographic characteristics, health behaviors and outcomes cross-sectionally and longitudinally and use these data to validate and compare relevant measurement tools.
The innovative aspects of the Generation Healthy Kids study are the combination of an intervention targeting several important risk factors for excessive weight gain (dietary habits, physical activity, sleep, and screen time) with community capacity building and a systems approach. The unique combination is closely monitored for effect as well as process. The integrated intervention program will be distinctive in combining already tested effective intervention strategies with intervention components developed using co-creation and a systems mapping and working in varying settings of the child's life. Systems thinking will furthermore be used to ensure that a health equity lens is employed to understand the relationship between obesity and health inequalities locally. To reach children and families with low socio-economic status, focus will be on developing interventions that make healthy choices easy by creating healthy environments around the children, both at school and during leisure time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Generation Healthy Kids intervention
The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders.
Food and Nutrition
A key element is that children receive a free of charge healthy do-it-yourself school lunch 4 days per week. The meals adhere to the Nordic Nutrition Recommendations and the Danish Food-Based Dietary Guidelines with focus on fish, wholegrains, fruits and vegetables and drinking water as well as stimulation of children's food literacy. Other intervention components involve the after school clubs, local retail stores and the parents.
Physical Activity (FitFirst)
To ensure that all children reach the recommended 3x30 minutes of vigorous activity per week, we will implement three weekly 40-minute sessions in the school curriculum. These sessions will be carried out throughout the study period and will encompass modified and varied sporting activities and games, which promote motivation, physical literacy, active involvement of all children, and high training intensity.
Sleep and screen media
The aim of this component is to promote healthy sleep and screen media behaviours. Sleep and screen media recommendations will be presented for parents at three parent workshops and in electronic infographics. Teachers/pedagogues will facilitate small assignments on screen media and sleep practices with children during school time. Children will talk about and reflect upon screen media and sleep practices in their family, based on assignments and material from e.g., Medierådet (The Danish Media Council). The results of the children's assignments will be presented to their parents at later workshops. This is done to integrate the children's perspective in the parent workshops, especially in relation to screen media habits.
Community capacity building
Community capacity building in selected local communities. To promote healthier eating, children and families need to be supported within their local community by food environments that make the healthy choice the easy choice and not a challenge in their everyday life. To promote physical activity, the children will be invited to participate in activities in the local sports clubs including camps in the holidays.
Control
The schools will continue with their regular school schedules.
No interventions assigned to this group
Interventions
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Food and Nutrition
A key element is that children receive a free of charge healthy do-it-yourself school lunch 4 days per week. The meals adhere to the Nordic Nutrition Recommendations and the Danish Food-Based Dietary Guidelines with focus on fish, wholegrains, fruits and vegetables and drinking water as well as stimulation of children's food literacy. Other intervention components involve the after school clubs, local retail stores and the parents.
Physical Activity (FitFirst)
To ensure that all children reach the recommended 3x30 minutes of vigorous activity per week, we will implement three weekly 40-minute sessions in the school curriculum. These sessions will be carried out throughout the study period and will encompass modified and varied sporting activities and games, which promote motivation, physical literacy, active involvement of all children, and high training intensity.
Sleep and screen media
The aim of this component is to promote healthy sleep and screen media behaviours. Sleep and screen media recommendations will be presented for parents at three parent workshops and in electronic infographics. Teachers/pedagogues will facilitate small assignments on screen media and sleep practices with children during school time. Children will talk about and reflect upon screen media and sleep practices in their family, based on assignments and material from e.g., Medierådet (The Danish Media Council). The results of the children's assignments will be presented to their parents at later workshops. This is done to integrate the children's perspective in the parent workshops, especially in relation to screen media habits.
Community capacity building
Community capacity building in selected local communities. To promote healthier eating, children and families need to be supported within their local community by food environments that make the healthy choice the easy choice and not a challenge in their everyday life. To promote physical activity, the children will be invited to participate in activities in the local sports clubs including camps in the holidays.
Eligibility Criteria
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Inclusion Criteria
6 Years
11 Years
ALL
Yes
Sponsors
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University of Southern Denmark
OTHER
Region Capital Denmark
OTHER
The Novo Nordisk Foundation
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Principal Investigators
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Nikolai B Nordsborg, PhD
Role: STUDY_DIRECTOR
University of Copenhagen
Jens Troelsen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Ulla Toft, PhD
Role: STUDY_CHAIR
Capitol Region of Southern Denmark
Locations
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11 schools in the Capital Region of Denmark and Region Zealand
Copenhagen, Capital Region and Region Zealand, Denmark
12 Schools in Region of Southern Denmark
Odense, Region Syddanmark, Denmark
Countries
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References
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Thomsen LT, Schmidt-Persson J, Damsgaard CT, Krustrup P, Grontved A, Krolner RF, Nielsen G, Lundbye-Jensen J, Skovgaard T, Molgaard C, Hansen ABG, Hoeeg D, Larsen MN, Lund L, Melby PS, Pedersen NH, Troelsen J, Nordsborg NB, Toft U. Generation Healthy Kids: Protocol for a cluster-randomized controlled trial of a multi-component and multi-setting intervention to promote healthy weight and wellbeing in 6-11-year-old children in Denmark. PLoS One. 2024 Dec 5;19(12):e0308142. doi: 10.1371/journal.pone.0308142. eCollection 2024.
Provided Documents
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Document Type: Study Protocol: Version 1.1, 6 March 2023
Document Type: Study Protocol: Version 3.0, 25 July 2023
Document Type: Study Protocol: Version 4.0, 26 February 2024
Document Type: Study Protocol: Version 5.0, 7 November 2024
Document Type: Study Protocol: Version 6.0, 17 January 2025
Document Type: Study Protocol: Version 2.2, 10 July 2023
Document Type: Statistical Analysis Plan: Version 1.0, dated 11 June 2025
Document Type: Statistical Analysis Plan: Version 2.0, dated 18 November 2025
Other Identifiers
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S-20220094
Identifier Type: -
Identifier Source: org_study_id
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