Childhood ObesityGHKNCT05940675
Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
A study testing Food and Nutrition, Physical Activity (FitFirst) and Sleep and screen media in people with Childhood Obesity and Well-Being, Psychological, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
The GHK intervention was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. A pilot- and feasibility study was conducted during December 2022-April 2023, and the intervention was subsequently adapted and adjusted. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Well-Being, Psychological, Physical Inactivity
- What is being tested?
- Food and Nutrition, Physical Activity (FitFirst) and Sleep and screen media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,372 participants
- Where
- 2 sitesDenmark
- Study dates
- 14 Aug 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children attending 1st or 2nd grade in the recruited schools
Who cannot join
- No exclusion criteria will be applied. If parents, teachers or research staff judge that a child cannot participate in certain parts of the intervention or measurement schedule, e.g. due to severe allergies, chronic diseases or mental/physical disabilities, the child will be eligible to participate in the remaining parts of the study.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
11 schools in the Capital Region of Denmark and Region Zealand
Copenhagen, Capital Region and Region Zealand
12 Schools in Region of Southern Denmark
Odense, Region Syddanmark, 5230
About this study
Official title: Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention to Promote Healthy Weight and Wellbeing in Danish School-aged Children
The GHK intervention was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. A pilot- and feasibility study was conducted during December 2022-April 2023, and the intervention was subsequently adapted and adjusted.
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.
Read the detailed description
Generation Healthy Kids is a cluster-randomized school and community trial in which 24 schools will be randomly allocated to intervention or control. Schools are evenly distributed in two areas of Denmark: DK-EAST (Capital Region of Denmark and Region Zealand) and DK-WEST (Region of Southern Denmark). The overall study objective is to investigate if a 2-school-year multi-setting, multi-component intervention focusing on healthy diets, physical activity, sleep and screen media habits in the school and local community can promote healthy weight and body composition in children who are in 1st and 2nd grade at inclusion (i.e., age 6-9 years at inclusion). We will also investigate the intervention's effects on dietary intake and nutritional status; food literacy; family- and school meal culture, physical literacy, activity levels, and fitness; sleep and screen media habits; growth; cardio metabolic health; cognitive and motor functions; school performance; and mental health and well-being. Furthermore, we will evaluate the context, implementation and working mechanisms of the intervention.
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
- Childhood Obesity, Well-Being, Psychological, Physical Inactivity, Sleep, Screen Time, Diet Habit
- Being tested
- Food and Nutrition, Physical Activity (FitFirst), Sleep and screen media, Community capacity building
- Keywords
- Obesity, Well-being, Physical activity, Sleep, Screen time, Community intervention, Socioeconomic Disparities in Health, Diet
- Medical subject headings
- Pediatric Obesity, Psychological Well-Being, Sedentary Behavior, Feeding Behavior, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food and NutritionBehavioural
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)Behavioural
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 mediaBehavioural
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 buildingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Generation Healthy Kids intervention | Experimental | The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders. Receives: Behavioral: Food and Nutrition; Behavioral: Physical Activity (FitFirst); Behavioral: Sleep and screen media; Behavioral: Community capacity building |
| Control | No intervention | The schools will continue with their regular school schedules. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass in kg
Between group difference in change in fat mass measured by bioimpedance analysis (InBody 270).
Measured: Baseline and 18-20 months
Secondary outcomes (10)
Fat mass in kg (2)
Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
Fat free mass in kg
Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
Fat mass index in kg/m2
Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
Fat free mass index in kg/m2
Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
Fat-Free-Mass-to-Fat-Mass ratio
Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
% Fat Mass
Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
Measured: Baseline , 6-8 months, 18-20 months
Height in cm
Between group difference in change in standing height measured using a portable stadiometer.
Measured: Baseline , 6-8 months, 18-20 months
Weight status in %
Between group difference in change in prevalence of children with underweight, normalweight, overweight and obesity, based on the cutoffs defined by Cole et al. and the International Task Force of Obesity. Body weight is measured by a bioimpedance analysis (InBody 270) and height by using a portable stadiometer.
Measured: Baseline , 6-8 months, 18-20 months
BMI z-score
Between group difference in change in BMI z-score based on WHO references. Weight and height is measured using weight from the bioimpedance analysis (InBody 270) and a portable stadiometer, respectively.
Measured: Baseline , 6-8 months, 18-20 months
Waist circumference in mm
Between group difference in change in waist circumference to the nearest mm by a non-elastic measuring tape at the level of the umbilicus.
Measured: Baseline , 6-8 months, 18-20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start14 Aug 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- None (open label)
- Enrolment
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region Capital Denmark, Novo Nordisk Foundation
- Responsible party
- Sponsor
- Investigators
- Nikolai B Nordsborg, PhD, Study director, University of CopenhagenJens Troelsen, PhD, Principal investigator, University of Southern DenmarkUlla Toft, PhD, Study chair, Capitol Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940675
- Sponsor's protocol ID
- S-20220094
- Acronym
- GHK
- Status last verified
- Nov 2025
- First submitted
- 4 Jul 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-indentified data will be shared.
Publications
Krolner RF, Brautsch LAS, Vilhelmsen M, Hoeeg D, Pedersen NH, Thomsen LT, Nielsen G, Toft U, Larsen MN, Damsgaard CT, Krustrup P, Bauman A, Skovgaard T, Lund L. Generation Healthy Kids: a protocol for the mixed methods process evaluation of a school- and community-based intervention targeting healthy weight and wellbeing among 6-11-year-olds in Denmark. Trials. 2026 Mar 23;27(1):341. doi: 10.1186/s13063-026-09635-1.
PubMed 41872954Thomsen 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.
PubMed 39636875
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention to Promote Healthy Weight and Wellbeing in Danish School-aged Children
- ClinicalTrials.gov ID
- NCT05940675
- Acronym / sponsor ID
- GHK / S-20220094
- Conditions
- Childhood Obesity, Well-Being, Psychological, Physical Inactivity, Sleep, Screen Time, Diet Habit
- Keywords
- Obesity, Well-being, Physical activity, Sleep, Screen time, Community intervention, Socioeconomic Disparities in Health, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,372 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region Capital Denmark, Novo Nordisk Foundation
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GHK intervention was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. A pilot- and feasibility study was conducted during December 2022-April 2023, and the intervention was subsequently adapted and adjusted.
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.
Detailed description
Generation Healthy Kids is a cluster-randomized school and community trial in which 24 schools will be randomly allocated to intervention or control. Schools are evenly distributed in two areas of Denmark: DK-EAST (Capital Region of Denmark and Region Zealand) and DK-WEST (Region of Southern Denmark). The overall study objective is to investigate if a 2-school-year multi-setting, multi-component intervention focusing on healthy diets, physical activity, sleep and screen media habits in the school and local community can promote healthy weight and body composition in children who are in 1st and 2nd grade at inclusion (i.e., age 6-9 years at inclusion). We will also investigate the intervention's effects on dietary intake and nutritional status; food literacy; family- and school meal culture, physical literacy, activity levels, and fitness; sleep and screen media habits; growth; cardio metabolic health; cognitive and motor functions; school performance; and mental health and well-being. Furthermore, we will evaluate the context, implementation and working mechanisms of the intervention.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Generation Healthy Kids intervention | Experimental | Behavioral: Food and Nutrition, Behavioral: Physical Activity (FitFirst), Behavioral: Sleep and screen media, Behavioral: Community capacity buildingThe intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders. |
| Control | No intervention | –The schools will continue with their regular school schedules. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children attending 1st or 2nd grade in the recruited schools
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied. If parents, teachers or research staff judge that a child cannot participate in certain parts of the intervention or measurement schedule, e.g. due to severe allergies, chronic diseases or mental/physical disabilities, the child will be eligible to participate in the remaining parts of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food and NutritionA 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. | Behavioural | Generation Healthy Kids intervention |
| 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. | Behavioural | Generation Healthy Kids intervention |
| Sleep and screen mediaThe 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. | Behavioural | Generation Healthy Kids intervention |
| Community capacity buildingCommunity 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. | Behavioural | Generation Healthy Kids intervention |
Primary outcome
Fat mass in kg
Time frame: Baseline and 18-20 months
Between group difference in change in fat mass measured by bioimpedance analysis (InBody 270).
10 secondary outcomes
Fat mass in kg (2)
Time frame: Baseline , 6-8 months, 18-20 months
Fat free mass in kg
Time frame: Baseline , 6-8 months, 18-20 months
Fat mass index in kg/m2
Time frame: Baseline , 6-8 months, 18-20 months
Fat free mass index in kg/m2
Time frame: Baseline , 6-8 months, 18-20 months
Fat-Free-Mass-to-Fat-Mass ratio
Time frame: Baseline , 6-8 months, 18-20 months
% Fat Mass
Time frame: Baseline , 6-8 months, 18-20 months
Height in cm
Time frame: Baseline , 6-8 months, 18-20 months
Weight status in %
Time frame: Baseline , 6-8 months, 18-20 months
BMI z-score
Time frame: Baseline , 6-8 months, 18-20 months
Waist circumference in mm
Time frame: Baseline , 6-8 months, 18-20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 41872954Krolner RF, Brautsch LAS, Vilhelmsen M, Hoeeg D, Pedersen NH, Thomsen LT, Nielsen G, Toft U, Larsen MN, Damsgaard CT, Krustrup P, Bauman A, Skovgaard T, Lund L. Generation Healthy Kids: a protocol for the mixed methods process evaluation of a school- and community-based intervention targeting healthy weight and wellbeing among 6-11-year-olds in Denmark. Trials. 2026 Mar 23;27(1):341. doi: 10.1186/s13063-026-09635-1.
- Derived from this study: PubMed 39636875Thomsen 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.
- Individual participant dataSharing planned: Yes. Only de-indentified data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolai B Nordsborg, PhD study director
University of Copenhagen
Jens Troelsen, PhD principal investigator
University of Southern Denmark
Ulla Toft, PhD study chair
Capitol Region of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food and Nutrition, Physical Activity (FitFirst) and Sleep and screen media in people with Childhood Obesity and Well-Being, Psychological, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass in kg (time frame: Baseline and 18-20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.