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
Phase: NA
Conditions: Childhood Obesity, Well-Being, Psychological, Physical Inactivity, Sleep, Screen Time, Diet Habit
Sponsor: University of Copenhagen

CONFIDENTIAL 
STØTTET AF     
 
  
 
 
Generation Healthy Kids 
Main study 
 
[Generation Sunde Børn - hovedstudie] 
 
 
Version: 6.0 
Date: 17-01-2025 

 
 
1 Responsible parties 
Principal Investigator:   
Professor, Jens Troelsen 
Head of Department of Sports Science and Clinical Biomechanics 
Faculty of Health Sciences, University of Southern Denmark  
Campusvej 55, 5230 Odense M, Denmark 
Phone: + 45 65 50 34 93 
E-mail: JTroelsen@health.sdu.dk  
 
 
Co-PI 
 
Professor, Nikolai Baastrup Nordsborg 
 
Head of Department of Nutrition, Exercise and Sports 
 
University of Copenhagen 
 
Nørre Allé 51, 2200 København N, Denmark 
Phone: + 45 35 32 16 12, 
E-mail: nbn@nexs.ku.dk  
 
Investigators: 
Professor, Ulla Toft 
Center for Clinical Research and Prevention 
Bispebjerg and Frederiksberg Hospital 
Nordre Fasanvej 57 
2000 Frederiksberg, Denmark 
Phone: +45 29 99 78 77 
E-mail: Ulla.toft@regionh.dk  
 
Associate Professor, Camilla Trab Damsgaard 
Department of Nutrition Exercise and Sports 
Faculty of Science, University of Copenhagen 
Rolighedsvej 26, 1958 Frederiksberg C, Denmark 
Phone: +4535332221 
E-mail: ctd@nexs.ku.dk 
 
Professor, Peter Krustrup 
Department of Sports Science and Clinical Biomechanics 
Faculty of Health Sciences, University of Southern Denmark 
Campusvej 55, 5230 Odense M, Denmark 
Phone: +45 21 16 15 30   
E-mail: pkrustrup@health.sdu.dk 
 
Professor, Anders Grøntved 
Department of Sports Science and Clinical Biomechanics 

CONFIDENTIAL 
 
Faculty of Health Sciences, University of Southern Denmark 
Campusvej 55, 5230 Odense M, Denmark 
Phone: +45 65 50 44 65  
E-mail: agroentved@health.sdu.dk   
 
Senior Research Fellow, Rikke Fredenslund Krølner 
Centre for Intervention Research  
University of Southern Denmark/National Institute of Public Health  
Studiestræde 6, 1455 Copenhagen K  
Phone: +45 65 50 78 41  
E-mail: rikr@sdu.dk   
 
GCP coordinator: 
Le Lene Susanne Simon Stevner 
Department of Nutrition, Exercise and Sports,  
Faculty of Science, University of Copenhagen 
Rolighedsvej 26, 1958 Frederiksberg C, Denmark 
Phone: +45 3533 2371 
E-mail: less@nexs.ku.dk  
 
Medical Expert and Clinically Responsible Physician: 
Professor, MD, Christian Mølgaard 
Department of Nutrition, Exercise and Sports,  
Faculty of Science, University of Copenhagen 
Rolighedsvej 26, 1958 Frederiksberg C, Denmark 
Phone: +45 35 33 25 16 
E-mail: cm@nexs.ku.dk 
 
 
 

 
 
 
 
 
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2 Table of Contents 
 
1 
Responsible parties .......................................................................................................... 2 
2 Table of Contents .................................................................................................................. 4 
3 Abbreviations and Definition of Terms .................................................................................. 7 
4 Background ............................................................................................................................ 8 
5 Study Objectives .................................................................................................................. 12 
5.1 Overall Objective........................................................................................................... 12 
5.2 Specific Objectives ........................................................................................................ 12 
6 Investigational Plan ............................................................................................................. 14 
6.1 Study Design ................................................................................................................. 14 
6.1.1 Justification of study design ................................................................................... 14 
6.1.2 Randomization ....................................................................................................... 14 
6.1.3 Timeframe of the trial ............................................................................................ 15 
6.1.4 Sample size justification ......................................................................................... 15 
6.1.5 Blinding .................................................................................................................. 16 
6.2 Study Participants ......................................................................................................... 16 
6.2.1 Inclusion Criteria .................................................................................................... 16 
6.2.2 Exclusion Criteria .................................................................................................... 17 
6.2.3 Withdrawal Criteria ................................................................................................ 17 
6.2.4 Recruitment of schools ........................................................................................... 18 
6.2.5 Recruitment and enrolment of study participants ................................................. 18 
6.3 Intervention .................................................................................................................. 22 
6.3.1 Principles of the intervention ................................................................................. 22 

 
 
 
 
 
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6.3.2 Interventions in schools and after-school clubs ..................................................... 24 
6.3.3 Interventions focused on the child through the family .......................................... 28 
6.3.4 Intervention focused on the local environment ..................................................... 30 
6.3.5 Compliance ............................................................................................................. 31 
6.4 Control schools ............................................................................................................. 32 
6.5 Overview of study procedures and activities ................................................................ 32 
6.6 Measurements and study procedures .......................................................................... 35 
6.6.1 Questionnaires to be filled in at home ................................................................... 35 
6.6.2 Other procedures at home ..................................................................................... 36 
6.6.3 Measurements in school ........................................................................................ 37 
6.6.4 Evaluation of measures related to implementation of the intervention and 
organizational aspects ..................................................................................................... 41 
6.6.5 Measurements at further school, community, and national level .......................... 42 
6.6.6 Use of the school’s recordings of children’s absence ......................................... 4243 
6.7 Adverse Events .............................................................................................................. 46 
6.8 Handling of biological samples .................................................................................. 4647 
6.8.1 Sample analysis .................................................................................................. 4647 
6.8.2 Genotypes and epigenetic analyses ....................................................................... 48 
6.8.3 Research Biobank ............................................................................................... 4849 
6.8.4 Biobank for future research purposes .................................................................... 49 
6.9 Data Management and Quality Control .................................................................... 4950 
6.10 Use of data from Danish registers ............................................................................... 51 

 
 
 
 
 
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6.11 Statistical methods...................................................................................................... 52 
6.12 Suspension or early termination of the study ......................................................... 5354 
6.13 Serious adverse events and reporting ......................................................................... 54 
6.13.1 Serious adverse events ......................................................................................... 54 
6.13.2 Reporting of Serious adverse events .................................................................... 54 
6.14 Study Documentation ................................................................................................. 55 
6.14.1 Publication of Results ........................................................................................... 55 
7 Ethical conduct of the study ................................................................................................ 55 
7.1 Ethical approval and study registration......................................................................... 55 
7.2 Justification of the study ............................................................................................... 55 
7.3 Underage study participants - justification and precautions ......................................... 56 
7.4 Children of ethnic minority ........................................................................................... 56 
7.5 Risks and safety in relation to conducting the study ..................................................... 56 
7.6 Benefits of the study and risk-benefit evaluation ......................................................... 58 
7.7 Participant Information and Informed Consent ............................................................ 58 
7.8 Protocol Changes .......................................................................................................... 59 
7.9 Protocol Deviations ....................................................................................................... 59 
7.9 Insurance ...................................................................................................................... 59 
8 Funding ................................................................................................................................ 59 
9 Remuneration for study participants ................................................................................... 60 
10 References ......................................................................................................................... 61 
11 List of Appendices (all in Danish) ....................................................................................... 72 
 

 
 
 
 
 
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3 Abbreviations and Definition of Terms 
AE 
BMI 
CCRP 
CRF 
DK-East 
DK-West 
FFM 
FM 
GDPR 
LCPG 
MVPA 
NEXS 
PA 
PE 
PL 
SDQ 
SDU 
SES 
SFO 
UCPH 
VPA 
Adverse Event 
Body Mass Index 
Center for Clinical Research and Prevention 
Case Report Form 
The Capital Region of Denmark and Region Zealand 
The Region of Southern Denmark 
Fat free mass 
Fat mass 
General Data Protection Regulation 
Local Community Partnership Group 
Moderate to Vigorous Physical Activity 
Department of Nutrition, Exercise and Sports 
Physical Activity 
Physical Education 
Physical Literacy 
Strengths and Difficulties Questionnaire 
University of Southern Denmark 
Socioeconomic Status 
After School Club 
University of Copenhagen 
Vigorous Physical Activity 
 

 
 
 
 
 
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4 Background 
4.1 The global problem of overweight and obesity  
Overweight and obesity among children is a global problem affecting more than 41 million 
children under the age of 5 years. The World Health Organization (WHO) describes childhood 
obesity as one of the most serious public health challenges worldwide for the 21st century 
(1,2). The prevalence of overweight and obesity in Danish children is 12-13% in primary school 
and increases to 18-19% at the time of graduation (3), why early prevention is important. In 
the adult population 51% are estimated to be overweight or obese (4,5).  
Overweight and obesity have many negative health consequences for children during their 
early years and in later life. For instance, children who have overweight or obesity are more 
likely to experience bullying, stigmatization and suffer from low self-esteem, anxiety, and 
lower quality of life (6). In addition, children with overweight and obesity have an increased 
risk of overweight and obesity as adults, which is well known to lead to poorer health and 
well-being and marked economic negative effects for the individual and for society.  
There are stark inequalities in the prevalence of childhood overweight, both worldwide and in 
Denmark, contributing to the health inequality found in most countries (4,7). In Denmark, the 
overweight prevalence among children aged 6-7 years in high-income families is 11% 
compared to 26% in low-income families. Among children aged 14-15 years, the prevalence 
of overweight is almost 30% in families with short education compared to 10% among those 
from families with long education (8).  
Many trials have been conducted to reduce childhood overweight and obesity, and several 
comprehensive systematic reviews have investigated the effect of different interventions in 
preventing childhood overweight and obesity (9–16). However, most of the earlier studies find 
no or only small effects on children’s body mass index (BMI), and the evidence of long-term 
effects is limited. 
Thus, there is a strong need to develop new innovative approaches and programs that 
effectively can prevent overweight among all children, starting early in life and embedding 
promising programs and integrated approaches into everyday practices.  
4.2 Important characteristics to increase likelihood of success  
Some of the earlier studies did show a significant effect on overweight measures. Across these 
studies, some characteristics and elements seem to increase the likelihood of success:  

 
 
 
 
 
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• A multi-component, multi-setting intervention, including well-planned involvement of 
relevant stakeholders, is likely to yield the highest level of effect in promoting healthy 
weight in children (17,18).  
• Multi-component interventions targeting two or more health behaviours (i.e., physical 
activity, dietary outcomes, sedentary behaviour, sleep) seems to be more successful 
in improving adiposity outcomes compared to single-component interventions (12–
14,19–24). Involving parents was found to be essential in the prevention of childhood 
overweight and obesity, especially among children younger than 12 years 
(9,11,13,23,25–29). However, less than half of the earlier studies involved parents (25). 
Among the studies that did involve parents, three out of four demonstrated positive 
outcomes in reducing BMI or weight status.  
Other characteristics that seem promising are: 
• Combining educational components (e.g. targeting the children’s knowledge, 
competences, literacy levels, and motivation) with environmental or structural 
components (e.g. free healthy school meals, smaller portion sizes, easy access to fruit 
and vegetables, physical activity as a part of the school day, free and/or easy access to 
leisure time activities, healthy space management of supermarkets, healthy 
alternatives in restaurants, decreased availability of fast food and sugary beverages, 
and healthy school policies) (9,13,16,28,29). The environment around the child, both 
at school and at leisure time (home and local community) must support healthy living.  
• Targeting a multitude of the settings where children spend their time (23,30) and 
including multiple intervention components (9–16). Several systematic reviews have 
shown limited effects of interventions that are purely school based (31).  
• Long-term interventions (twelve months or longer) appear to be more effective 
compared to studies of shorter duration (9,13). 
• Co-creation and involvement of relevant stakeholders was also found to be an 
important factor in earlier, successful studies. This means involving stakeholders in 
identifying, prioritizing, developing, and implementing interventions using co-creative 
approaches and capacity building processes (32–37).  (16,38,39).  
4.3 Key components in prevention - diet, physical activity, screen time and sleep  
Healthy diets and balanced energy intake are key factors in prevention of overweight in 
childhood, which must be addressed simultaneously in different settings for maximal effect, 
in a manner that supports food literacy, practical competence and long-term behaviour 
change via environmental changes. Danish children consume too little vegetables, 
wholegrains, and fish, and too much sugar and fat, compared to the Danish food-based 
guidelines and the Nordic Nutrition Recommendations (40–42). This worsens with age, which 

 
 
 
 
 
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means that preventive efforts are needed at an early age. There is considerable social 
inequality in dietary behaviours, as Danish children from households with short compared to 
long education consume less fruits, vegetables, dietary fibre, and fish and often skip breakfast 
(43). School food programs can improve dietary quality (44), and in Sweden, provision of free 
school lunches during basic school has been associated with long term effect on different 
indicators for better health and well-being, including education attainment, higher salaries, 
and higher final height later in life (45).  
The diet of Danish children has been found to be less healthy during weekends compared to 
weekdays (46), and studies have shown that children primarily learn about eating behaviour, 
dieting, cooking etc. by watching their parents. Further, parents define their children’s home 
food environment, e.g., access to healthy and unhealthy food items and whether there are 
family rules limiting the intake of unhealthy foods (47,48).  
Physical activity (PA) is an important part of a healthy lifestyle for children, as it improves 
physical fitness, motor competences and well-being, and reduces the risk of developing 
overweight and non-communicable diseases later in life (49). Current recommendations are 
that children and adolescents should participate in at least 60 minutes of moderate-to-
vigorous physical activity (MVPA) per day and 3x30 minutes of vigorous physical activity (VPA) 
per week. However, in Scandinavia and the rest of Europe, many children do not reach these 
targets (50,51).  
A high percentage (about 70 percent) of 7-9-year-old children in Denmark participate in one 
or more club-organized sports. This contributes significantly to these children’s MVPA and 
increases their chance of being active at a later age, when physically active free play during 
e.g., recess decreases. The participation rates, however, are much lower for children whose 
parents have low sporting experience and in families with limited socioeconomic resources. 
Excessive recreational screen media use and short- and poor-quality sleep are important risk 
factors for the development of childhood obesity (52,53). While high screen use may be 
obesogenic by displacing engagement in PA during leisure time, it may also lead to insufficient 
sleep among children (54). Sleep is not only critical for learning, memory, and school 
performance. Inadequate sleep also disrupts hormone levels that regulate appetite and food 
intake (53). A third of Danish 6-11-year-old children use screen media >4 hours/day during 
weekends, and 24% of children in this age group report screen use just before bedtime on all 
weekdays (7,55). Furthermore, significant socioeconomic disparity is seen in children’s screen 
media use, with higher prevalence of excessive recreational screen use and screen use just 
before bedtime in children from socioeconomic disadvantaged families. Insufficient sleep is 
also more common among children from families of low socioeconomic status (56). 

 
 
 
 
 
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In addition, we observe that more healthy screen use practices appear to be promoted by 
well-established parental rules of screen media use hygiene (when to use screen media, 
content- and amount of use), and we find a graded relationship of total recreational screen 
use, screen use just before bedtime and sleep time of children (57). 
4.4 Generation Healthy Kids – the innovative approach 
Generation Healthy Kids will build on the existing evidence, combining the characteristics and 
elements described above to improve the chance of success. The innovative aspects of the 
project are the combination of a randomized controlled trial 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 (58). The unique combination is closely 
monitored for effect as well as process. The integrated intervention program will be unique in 
combining already tested effective intervention strategies with intervention components 
developed using co-creation and a systems mapping (58). 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 (59). 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. 
4.5 The pilot study and the main trial 
Generation Healthy Kids is a 4-year project including a pilot study which was conducted in 
January-April 2023, and a 2-year cluster-randomized controlled main trial to be conducted in 
August 2023 – June 2035 (including time for analysis of samples and data and publication). 
The present protocol describes the main trial. 
The pilot study was approved by The Regional Committee on Health Research Ethics for 
Southern Denmark (Project ID 568021-22 S-20220059). 
A thorough development and piloting is an essential prerequisite for ensuring feasibility and 
quality of the final intervention program to be assessed via the main trial. Based on the 
learnings and results from the pilot study, the final intervention program has been adjusted 
accordingly. Due to the timeline of the main trial, this protocol was originally submitted before 
the pilot study was conducted (protocol version 1.0, submitted 1 December 2022). 
Adjustments based on learnings and results from the pilot study were included in the first 
amendment protocol (protocol version 2.0 was submitted 12 May 2023 and was partly 
approved by the Committee on 6 July 2023; protocol version 2.2 provided response to the 
Committee’s partial approval of 6 July 2023). The present second amendment protocol 

 
 
 
 
 
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(protocol version 3.0) describes some further adjustments to the study protocol prior to study 
initiation. 
5 Study Objectives  
5.1 Overall Objective  
Generation Healthy Kids is a cluster-randomized school and community trial in which 24 local 
schools will be randomly allocated to intervention or control. 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 competences; 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 wellbeing. Furthermore, we will 
evaluate the implementation 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, genetics, 
epigenetics etc. We will also explore associations between sociodemographic characteristics, 
health behaviours and outcomes cross-sectionally and longitudinally and use these data to 
validate and compare relevant measurement tools.  
The primary outcome is fat mass (FM) in kg. We hypothesize that the combined intervention 
components will counter the development of increasing overweight and unhealthy weight 
with age and thus will cause less FM gain in the intervention group compared with the control 
group. 
5.2 Specific Objectives 
5.2.1 Main objective 
The main objective is to investigate the impact of the 2-school-year intervention program on 
development of FM in the intervention group compared with the control group. 
5.2.2 Secondary objectives 

 
 
 
 
 
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As secondary objectives, we will investigate the impact of the intervention program after 1 
and 2 years on: 
- 
Other body composition measures, including fat free mass (FFM), FFM index, FM 
index, FFM-to-FM ratio, % FM; 
- 
Anthropometric measures and growth, including BMI z-score, prevalence of obesity, 
overweight, normal weight and underweight, waist circumference, linear growth and 
growth-related biomarkers; 
- 
Cardio metabolic health, including blood pressure, blood lipid profile, insulin resistance 
markers; 
- 
Other health related outcomes, including inflammation; 
- 
Cognitive and motor functions, physical literacy, and school performance; 
- 
Mental health and wellbeing;  
- 
Dietary intake, biomarkers of food and nutrient intake and status and appetite and 
food competence; 
- 
Physical activity, physical fitness, leisure-time activities, sleep- and screen media 
habits; 
- 
Long-term (>2 years) body composition based on height and weight obtained from 
routine data in The National Child Health Register (Børnedatabasen).   
Also, the collected data will be used for validations of associations between biological 
mechanisms and various measurements and outcomes (data analysed as observational data 
e.g., based on baseline data, longitudinal data or using the data from one group only), as well 
as the impact of background characteristics, such as socioeconomic position, family 
characteristics, sex, ethnicity, genetics, and epigenetics etc. on the effectiveness of the 
intervention. 
A specific objective of Generation Healthy Kids is to involve relevant local and national 
partners in the development and implementation of the multi-component intervention 
program, and to create local engagement and ownership for the implementation of the 
intervention. The project will work with multiple public, private and non-governmental 
organizations in the local community, including leisure time- and sports organizations, 
supermarkets, restaurants, and fast-food chains, to create healthier environments, e.g., by 
increasing access to healthy foods in supermarkets. The effects of such initiatives will be 
monitored and evaluated by e.g., sales data and measures of shelf-space allocation from 
supermarkets. 
In addition, an objective of the study is to understand and document implementation-related 
factors, causal mechanisms and contextual factors which shape the intervention’s outcomes. 
Therefore, a thorough process evaluation will be conducted, see section 6.5.4. 

 
 
 
 
 
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A protocol résumé is found in Appendix 1. 
6 Investigational Plan 
6.1 Study Design 
The study will be designed as a community-based open label cluster randomized superiority 
trial with two arms (intervention and control). Individual schools will form the basis of the 
cluster. A comprehensive list of all schools will form the school sampling frame, which is 
further explained in section 6.2.4. Teachers and pedagogues at each school will have a key 
role in implementing, coordinating, and anchoring the intervention.  
Geographically, the 24 schools are located in either DK-East, which includes Region Zealand 
and the Capital Region of Denmark and is mainly administered by University of Copenhagen 
(UCPH), or in DK-West which includes The Region of Southern Denmark and is mainly 
administered by the University of Southern Denmark (SDU). 
6.1.1 Justification of study design  
The study is designed as an open label cluster randomized trial as the primary objective of the 
study is to examine the effectiveness of the Generation Healthy Kids Program on the primary 
and secondary outcomes specified in sections 5.1 and 5.2.  
6.1.2 Randomization 
In this cluster-randomized trial, randomization will occur at school level and will be performed 
prior to inclusion of participants (i.e., children) and collection of informed consent. A stratified 
block randomization will be carried out in a 1:1 ratio. To prevent baseline imbalance of cluster 
characteristics across the two study arms, we will use covariate-constrained randomization 
(60). The covariates will be at school- and school district level with tentative factors being 
number of classes per school year (at least two classes per school year required); the 
socioeconomic profile of the school based on parental educational level (proportion of parents 
with a shorter education); ethnicity of the children (proportion of pupils with non-Danish 
origin in the respective school); and degree of urbanization of school district. The 
randomization procedure will be carried out by a statistician not otherwise involved in the 
project (i.e., not involved in recruitment of schools or participants), and the procedure will be 
concealed to the investigators. 

 
 
 
 
 
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6.1.3 Timeframe of the trial 
The trial will run over two school years (2023-24 and 2024-25). Baseline data will be obtained 
before the start of the intervention, and follow-up data will be collected during the two school 
years period.  
6.1.4 Sample size justification 
The sample size calculations are based on the primary outcome for the study being FM (kg) at 
18-22 months as measured by air displacement plethysmography (BODPOD). For the power 
calculation, a mean cluster size of n=58 children is assumed, which we expect based on the 
current status of recruitment of schools. We anticipate a total of 2,350 eligible children and a 
participation rate of 70%, and with an expected drop-out/missing data rate of 15%, which 
provides an expected mean of 58 children in each of the 24 clusters in the analytical sample. 
Others and we have managed to limit missing data to approximately this amount in previous 
large-scale school-based cluster randomized trials in young people (61–63). Thus, we aim to 
enrol a mean of n=69 children from each school. We assume a cluster size coefficient of 
variation of 0.24 based on the OPUS School Meal Study (64) PHASAR data (65) (1st to 4th grade 
children), a standard deviation of FM of 4.65 kg in both groups based on OPUS, and a 
conservative estimate of the intra-cluster correlation coefficient in FM (kg) of 0.03 based on 
PHASAR data (PI´s of the OPUS and PHASAR study are part of the scientific team in Generation 
Healthy Kids). Finally, because we plan to adjust for baseline FM (kg) in our primary analysis, 
we also assume a correlation between baseline and follow-up FM (kg) of 0.8 in the power 
calculation. With an expected enrolment of 24 clusters in 1:1 ratio allocation to intervention 
and control, we have decided to additionally control for type-1 error due to a planned 
correction of small (cluster) sample using the Satterthwaite correction for mixed linear models 
(66) by lowering alpha to 0.025 in the power calculations. With a cluster size of 58 and 24 
clusters (expected n=1,398 children in the analytical sample and 1,645 enrolled children at 
baseline), we have a power of 80% to detect a significant mean difference of -0.81 kg FM or 
greater at 18-22 months between intervention and control. In OPUS data, this difference 
corresponds to -0.15 BMI-z score (95% CI -0.15; -0.17), and a previous cohort study based on 
The Copenhagen School Health Records Register reported that a 1 kg increase in FM at 10 
years of age was associated with a 12% and 15% increased risk of type 2 diabetes at 50 years 
of age for boys and girls, respectively (67), which corresponds to a 10% and 12% decrease in 
risk per -0.81 kg FM. Thus, the planned study is powered to detect a fairly small, but also 
clinically relevant size of mean difference in FM at 18-22 months between intervention and 
control. 

 
 
 
 
 
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For the blood sample outcomes, we expect 12 clusters (DK-East) with an expected 1175 
children being eligible to participate. As we expect a 50% participation rate for blood sampling 
and 15% missing data rate, the mean cluster size will be 42 children in the analytical sample. 
With this cluster size, 12 clusters, and assuming a correlation between baseline and follow-up 
HDL cholesterol of 0.65, a standard deviation of 0.31 mmol/L in both groups based on OPUS 
data we have a power of 80% to detect a significant mean difference of 0.10 mmol/L HDL 
cholesterol or greater at 18-22 months between intervention and control (alpha=0.025). 
6.1.5 Blinding 
The study will be open label, as it will not be possible to blind participants due to the nature 
of the intervention. Also, it is not possible to blind personnel delivering the intervention (i.e., 
teachers). Outcome assessors will not be blinded, as we judge this to be impossible to 
implement with success. However, the primary outcome (FM) is objectively assessed not 
involving judgement by the assessor during the assessment and therefore unlikely to be 
influenced by knowledge of intervention allocation. 
6.2 Study Participants 
The study population will be approximately 1,600-1,700 children in 1st and 2nd grade (i.e., 
age 6–9 years at baseline) who attend 24 schools in DK-East (Capital and Zealand Region) and 
DK-West (Region of Southern Denmark).   
We have selected young school children as the target group for the intervention, because the 
prevalence of overweight and obesity increases from early childhood until adolescence, from 
approximately 12-13% at ages 6-7 years to approximately 18-19% at ages 14-15 years (68–72). 
Furthermore, early childhood is an important time period for formation of habits in relation 
to diet and physical activity which may persist into adulthood (73). Thus, early intervention is 
crucial to prevent unhealthy weight development. 
6.2.1 Inclusion Criteria 
All children attending 1st or 2nd grade in schools recruited into the study will be eligible to 
participate. 

 
 
 
 
 
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6.2.2 Exclusion Criteria 
There are no exclusion criteria for the children. If a child has food allergies, plaster allergies, 
or chronic disease (Appendix 2A and 2B) that cannot be accommodated in parts of the 
interventions or measurements, or if the parents, teachers, or research team judge that a child 
has physical or mental disabilities which cannot be accommodated in parts of interventions or 
measurements, the child can participate in the remaining parts of the program.  
6.2.3 Withdrawal Criteria 
The parents will be informed that they can withdraw their child from the study at any time 
and for whatever reason without any explanation or consequences for the child's daily life at 
school. If parents withdraw their child, they will be asked if they are willing to explain the 
reason, but responding is optional, i.e., entirely voluntary (see Appendix 3). In case of 
participant withdrawal, the data collected up to the point of withdrawal will be used in data 
analyses. Withdrawn participants will not be replaced.  
The Primary Investigator and Clinically Responsible Physician (independently of each other) 
have the right and obligation to terminate participation of any child at any time if it is deemed 
to be in the best interest of the child, e.g.:  
• If a child’s safety or well-being is compromised by further participation 
• If the investigator judges that the child does not want to continue his/her participation 
 
Or in the interest of completion of the study, e.g.: 
• If the child does not comply with the study procedures in a way that impacts the 
scientific integrity of the study. 
In this case, reasons for termination of the child’s participation will be recorded, and the 
child’s parents will be informed about the decision.  
Dropouts and children who do not participate in the study will not be excluded from 
participating in activities which are incorporated as a part of the school’s regular schedule and 
activities, including physical activity during school time, school meals, and learning activities 
during school time regarding screen media habits, sleep habits and food competences. 
However, no data will be collected from these children.  

 
 
 
 
 
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6.2.4 Recruitment of schools 
The sampling frame of the study will be constructed based on information on all schools in 
Denmark obtained from The Danish Ministry of Children and Education data-warehouse. 
Information obtained at school-level will include the number of children attending each school 
in 1st and 2nd grade. Special schools and schools in areas that already take part in similar 
research projects will not be eligible for participation. An initial sampling frame list will 
prioritize schools with at least two classes per year group and relative geographical proximity 
to the study centres. This sampling frame list will be expanded if the success of recruiting 
schools is lower than expected.  
The schools selected to be part of the sampling frame will be contacted directly via the school 
leader and/or the head of the school board, and the school will be invited to participate in the 
study. Furthermore, municipalities will be contacted to assist with recruitment of schools and 
to ensure overall support for the study. Finally, in addition to this direct recruitment 
procedure, an open advertisement for the study will be placed on relevant platforms (e.g., 
Folkeskolen.dk and LinkedIn) to recruit potentially interested schools for the study. 
6.2.5 Recruitment and enrolment of study participants 
6.2.5.1 Invitations 
Families in the selected schools and classes will receive invitations to the study through Aula 
and in printed form from teachers. Aula is an online communication platform used by all 
schools and approved for the processing of sensitive information.  
The invitation message on Aula will include: 
• An invitation letter, including an invitation to information meetings about the study at 
the school (Appendix 4A and 4B) and an electronic link to sign up for the information 
meeting;  
• Written participant information about the study (Appendix 5A and 5B);  
• The 
pamphlet 
‘Forsøgspersonens 
rettigheder 
i 
et 
sundhedsvidenskabeligt 
forskningsprojekt’ reviewed and published by the ethical committee system, Jan 2023, 
will be included on the last page of the participant information. 
• Information about processing of participants’ personal data and biological material in 
accordance with the European General Data Protection Regulation (GDPR). 
Parents (or custody holders) are asked to carefully read all the information material and to 
explain the content to their child/children. The information material will be translated into the 

 
 
 
 
 
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languages judged by the schools and research team to be most relevant for the included 
classes. 
Parents sign up for information meetings at the school via a secure online system. Parents are 
informed that they must bring their child to the information meeting, and that they can also 
bring an assessor (”bisidder”) if they wish.  
Prior to the information meetings, members of the research team will visit the schools in the 
morning during the time slot where children are usually dropped off at school, and/or in the 
afternoon when children are usually picked up or at other times considered relevant by the 
school. The researchers will hand out one-page information leaflets about the study (Appendix 
8A and 8B), encourage parents to participate in the information meetings, and answer any 
questions from parents about the study. In addition, one-page information leaflets will be 
handed out to parents in the involved classes by research team members and school staff, and 
posters about the project will be posted at the schools (Appendix 9).  
Members of the research team will also visit the involved classes during school time and 
inform the children about the study activities in a language and at a level appropriate for their 
understanding, cf. Committee Act § 5, stk. 2. The parents and children will always be informed 
that participation is entirely voluntary, and that the decision on whether to participate will in 
no way impact the child’s schooling.   
6.2.5.2 Information meetings for families at the school 
The information meetings will be held at the school in groups of maximum 25 families per 
room. Parents will be informed that they must bring their child to the information meeting.  
At the meetings, the background and objectives of the study will be presented by the 
Investigator, or by a qualified person who is delegated to give the information, and the parts 
of the study that involve the family and child will be explained in detail to both the parents 
and the children (see the content of the information meeting in “Table 1. Overview of study 
procedures and activities“).  Short videos illustrating the different measurement procedures, 
(e.g. the BODPOD, accelerometer, measurement of blood pressure and blood sampling) may 
be presented (Appendix 27A-D). Also, the parents will be informed that in case of an incidental 
finding concerning their child, e.g. hypertension, they will be contacted either by phone or e-
mail if it is judged to be clinically relevant by the Clinically Responsible Physician. 
In line with the Committee Act § 5, stk. 2, information to the children will be provided in a 
language and at a level that is appropriate and suited for the children’s age and 
comprehension. The information to the children will be provided by project staff experienced 
in communicating to children or who have been trained specifically for this task. There will be 

 
 
 
 
 
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time and room for asking questions, also in a separate room one-to-one. If the parents or the 
child are unable to participate in the information meetings, they can have the oral information 
for themselves (see below section 6.2.5.4). If the project staff judges that some parents need 
a second explanation of the study, this will be encouraged. It will be emphasized that the 
participants have the right to at least 24 hours consideration time, that participation is 
voluntary, that the participants can withdraw from the study at any time without giving a 
reason and without any consequences, and that all personal data will be kept strictly 
confidential. It will be ensured that parents with insufficient knowledge of Danish will be 
adequately supported to fully understand the information provided.  
The research team will register which parents and children are present at the information 
meetings, and during information provided to children in the classroom, in order to make sure 
that the custody holders and the child have received thorough oral participant information 
and fully understand the study and its procedures. 
6.2.5.3 Informed consent process 
Parents/custody holders will only be able to provide written informed consent if 1) the parents 
have received both written and oral participant information in accordance with the 
Committee Act § 5, stk. 1, and 2) the child has received oral participant information about the 
study in accordance with the Committee Act § 5, stk. 2. All parents/custody holders are 
informed that they are entitled to a consideration period of minimum 24 hours. 
In case the parents/custody holders and the child want the child to participate and do not wish 
further consideration time, both parents/custody holders together with investigator or a 
delegated and qualified person fill out the paper version or an electronic version of the 
consent form (Appendix 6A and 6B, Standard Forms S6 and S5) at the information meeting. 
The electronic consent form will be accessible via a link to RedCap (see further below in section 
6.2.5.4). Parents will also be informed that by signing the informed consent they give 
permission for the controlling authorities to access their data, and that a person carrying out 
these functions is subject to the rules of confidentiality. 
In the supplementary information about GDPR, parents/custody holders and participants will 
receive additional information about the way data and biological material are collected, 
shared, and made available for other researchers and data processors in compliance with 
GDPR. 
If parents/custody holders or children wish further time for consideration, the 
parents/custody holders will receive a link to the electronic version of the informed consent 
form. This will be sent via Aula or a personal e-mail address or phone number they provide to 

 
 
 
 
 
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the research personnel. The informed consent form must be signed by the parents/custody 
holders and the investigator or a delegated and qualified person, and any additional questions 
from the parents must be answered. No study procedures will be initiated before the informed 
consent is obtained.  
One parent or custody holder can empower the other parent or custody holder to decide 
whether the child should participate (Appendix 7). An electronic solution for this will also be 
made available to the parents/custody holders (Appendix 7).  
As the study participants are under the age of 18, they cannot give informed consent. 
However, the project staff will at all times during the study be aware of the child’s response 
and reactions to the study (both verbal and non-verbal responses); if the project staff at any 
time judges that the child does not want to participate in the study, the child will not be 
included. 
6.2.5.4. The electronic consent form 
Parents/custody holders can fill out the consent form (Appendix 6A and 6B, Standard Forms 
S6 and S5) electronically via a link they receive via Aula, or via a personal e-mail address or 
phone number they provide to the research personnel. They can sign the electronic consent 
form by drawing their signature in the designated field. After signing the form, data is 
encrypted and sent to a REDCap server at the researcher service Odense Patient Data 
Explorative Network, and a static copy of each completed form will be stored in REDCap 
ensuring that the forms cannot be edited. A copy of the completed form will also be sent 
directly to the participants’ e-mail address.  
The identity of the parent/custody holder who received the link to the electronic consent form 
is verified via the Aula platform where parents are verified via NemID/MitID upon their first 
login or in person.  
6.2.5.5. Parents who do not participate in information meetings 
Follow-up information meetings, either in groups or as individual meetings, online or face-to-
face, will be arranged for parents/custody holders and children who were not able to 
participate in the initial meetings.  
School staff will be asked to encourage families to participate in information meetings to learn 
about the study, but it will always be stressed that participation in the study is completely 
voluntary, and that a decision not to participate will in no way impact their child. We will ask 
school staff (e.g., teachers and pedagogues) to offer parents the possibility to be contacted by 

 
 
 
 
 
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telephone by a member of the research team, if the parents wish further information about 
the study before deciding whether to participate.  
6.2.5.6. New pupils enrolled in the schools during the study period 
If new pupils are enrolled in the participating school classes during the intervention period, 
they and their parents will be invited to participate in the study. Parents will initially be 
contacted by the schoolteacher via Aula or in person. If they are interested in hearing more 
about the study, the parents and children will receive an invitation letter (Appendix 4Aa or 
4Ba) oral and written participant information by the research team following the same 
procedures as described above in section 6.2.5.5. Written informed consent will be obtained 
from custody holders before enrolment into the study, and the parents will be asked to fill out 
appendix 2A or 2B about allergies, chronic diseases etc. at enrolment.   
6.2.5.7 Recruitment of local stakeholders 
For eight of the 12 intervention schools, an expanded local community intervention will be 
performed (see section 6.3.4 for further details). In these local intervention communities, a 
stakeholder analysis will be done together with representatives from the municipality and 
school. Potentially relevant stakeholders will initially be invited for a bilateral meeting. 
Relevant stakeholders will initially be defined as community leaders who have authority to 
initiate action within child health and well-being, including leaders from the municipality, the 
local school, local sports- and leisure time organizations, and private businesses such as local 
supermarkets and restaurants. These leaders will build a system map of drivers of obesity in 
the local community as further described in section 6.3.1. The system map captures drivers of 
childhood obesity in the local community. Subsequently, a larger group of community 
representatives will be engaged from organizations whose activities and agenda includes 
remit and capacity to influence children’s food and activity environments, screen time and 
sleep. Furthermore, selected local leaders and stakeholders in each community will be invited 
into a Local Community Partnership Group (LCPG) that will function as a steering group during 
the project period and help ensure coordination and long-term local anchoring of the 
intervention program. 
6.3 Intervention  
6.3.1 Principles of the intervention 
The development of the intervention in the intervention schools will be guided by the Medical 
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approach (58,74,75). Furthermore, the super-setting approach will guide the process of 
creating synergy between intervention components (76). 
The development of the intervention will take place on three levels: 
a) Core intervention components at school level based on existing evidence  
b) Intervention components developed in co-creation with national stakeholders 
c) Community capacity building in selected intervention local communities 
The core intervention components at school level are pre-defined based on existing evidence 
and will be described in section 6.3.2 Intervention in schools and after school clubs. The 
intervention at school level will be refined based on experiences from the pilot study. 
Furthermore, the intervention components will be adapted to the local context of each school. 
Other interventions will be developed primarily outside school, focusing especially on 
changing the environmental drivers of childhood obesity (social, cultural, physical, economic, 
and political). Inspired by the Public Health England’s publication “Whole systems approach 
to obesity: A guide to support local approaches to promoting a healthy weight” (59), a co-
creation process with national stakeholders took place prior to the pilot study to develop 
relevant interventions. The national stakeholders included representatives from national 
supermarket chains, fast food restaurants, Rådet for Sund Mad [Council for Healthy Food], 
national leisure time organisations, Local Government Denmark (KL), The Danish Healthy 
Cities Network, Danish Health Authority, The Danish Food Administration etc. After the initial 
stakeholder analysis, the process of co-creation consisted of a series of bilateral meetings and 
two workshops. In the first workshop, a systems map was developed using the software 
STICKE (77). In the second workshop, stakeholders came together to prioritise areas to 
intervene in the local system and propose collaborative and aligned actions to bridge 
interventions between settings. The project drew on the expertise and resources of The 
Intersectoral Prevention Laboratory (www.forebyggelseslaboratoriet.dk) who is responsible 
for the process of facilitating the creation of a systems map using STICKE. 
Community capacity building will take place in some of the local intervention communities 
(eight of the intervention schools, located in six different municipalities). Initially, a 
stakeholder analysis will be conducted to identify community leaders and stakeholders that 
have authority to initiate action and that would be relevant to engage in an intervention 
anchored in the local community promoting healthy weight among local children. Inspired by 
the cluster-randomized trial, WHO STOPS (78), the process will consist of the phases listed 
below:   

 
 
 
 
 
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• Collecting and communicating local data and scientific evidence to raise local 
awareness of childhood obesity and to engage and recruit community leaders.  
• Identifying, inviting, and working with a smaller group of community leaders who 
have authority to initiate action, including leaders from the municipality, the local 
school, local leisure time organisations, and private businesses including local 
supermarkets and restaurants. These leaders will build a causal loop diagram of 
the causes of childhood obesity in their community (79) using STICKE (77).  
• Engaging a larger group of community representatives from organizations whose 
activities and agenda includes remit and capacity to influence children’s food and 
activity environments, screen media habits and sleep.  
• Involving the larger group of community representatives in working together to 
design actions to prevent childhood obesity that they can carry out across the 
community, inspired by the causal loop diagram or systems map and informed by 
a prepared evidence brief on obesity prevention, including case studies from 
previous successful interventions.  
• Ongoing data collection and updates of the systems map to enhance 
implementation and diffusion of the selected actions and stimulate new ideas in a 
constructive, capacity-building cycle.  
• Selected local leaders and stakeholders in each local community will be invited into 
a LCPG that will function as a steering group.  
To develop an overall coordinated intervention programme, the different intervention 
components developed at different levels and in different settings will be combined using the 
Super-setting Approach (76). To promote integration and synergy between interventions, 
common themes for all settings (e.g., mental well-being, taste and senses etc.) will run 
throughout the intervention period for 2-3 months each. 
6.3.2 Interventions in schools and after-school clubs 
Prior to initiation of the intervention and measurement schedule (cf. section 6.6.), project staff 
may visit the school classes and explain the study activities to the children during school time 
in their classroom. This will occur at a level appropriate for the children’s age group by project 
staff specifically trained for this task. Children whose parents have not provided informed 
consent to participate in the study will be exempted from this information, unless it is relevant 
for all children (e.g. if it relates to the school meals that will be offered to all children in the 
classes, regardless of participation in the measurement schedule). 
School management and school boards at the intervention schools will be offered counselling 
and guidance on developing and implementing school policies within the project’s focus areas, 

 
 
 
 
 
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e.g. school policies on digital devices, physical activity during the school day, and school 
dietary policies. 
 
6.3.2.1 Food and nutrition 
The dietary intervention will be based on the national Danish food-based dietary guidelines 
(40) and the Nordic Nutrition Recommendations (41) and seeks to promote a balanced energy 
intake, increased healthy food intakes, and improving children’s healthy food competences. A 
key focus will be on increasing intakes of wholegrains, fruits, vegetables and legumes, and fish, 
reducing the intake of sugar, and on drinking water. 
The dietary intervention in school will include pre-prepared do-it-yourself lunch, consisting of 
for example rye bread sandwiches, pasta salad, raw vegetables etc. 4 days per week in most 
school weeks. The children will be involved in the table setting and cleaning after the meals. 
We expect that extra time will be needed to be scheduled for eating by the schools. Lunch will 
be offered to all children regardless of their participation in the measurement schedule and 
will be free of charge. We will collect information about allergies and other dietary 
considerations from the parents of participating children at enrolment (Appendix 2A). Parents 
will be informed that the meals cannot accommodate special dietary needs and that the menu 
with full list of ingredients (including allergens) will be posted on a specific website one week 
before, for them to check which parts their child can eat. The teachers/pedagogues will help 
handle allergies in the eating situation as in a normal school day. We will ask the teachers to 
inform us about food allergies in children who wish to have the meals, but who are not 
participating in the measurements. To encourage water consumption, cold-water dispensers 
will be made available if this is feasible. 
In addition to this, we will provide tips and inspiration materials for the parents on how to 
make easy, healthy midmorning snacks, and if relevant also lunch packs. We will also develop 
fun and engaging materials and hands-on food competence exercises that the teachers can 
use in their teaching to support the children’s knowledge, self-efficacy and liking of healthy 
foods as well as practical skills in food preparation. Examples are videos about the food served, 
vegetable rhyme books, sensorics taste exercises, vegetable puzzles and following a recipe to 
cook a simple dish together in the school kitchen.  
In the after-school clubs (SFOs), we will work with their existing offers of breakfast and 
afternoon snacks and provide tips and inspiration to encourage the staff to follow the national 
food-based guidelines. Other activities focusing on healthy diet may be arranged in 

 
 
 
 
 
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collaboration with the SFO, such as afternoon café for parents where children cook and serve 
healthy snacks or meals and/or excursions to local farmers, greengrocers, or fishmongers. 
6.3.2.2 Physical activity 
The amount of moderate and vigorous PA during school time will be increased through three 
approaches: a) 3x40 minutes of organized vigorous PA, b) education of teachers and c) 
improved facilities and structure for PA during recess and in after school clubs. 
a) 3x40 minutes per week of organized vigorous physical activity during school time 
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 (80) and games, which promote motivation, active involvement of all 
children, and intensity. These 40-min sessions are developed to promote joy though play, 
provide appropriate challenges of the children’s motor competences and physical capacity 
and, importantly, to achieve at least 30 minutes of varied, vigorous activity in relation to 
cardiopulmonary and musculoskeletal loading for all children, irrespectively of sex, fitness 
levels, skills, and prior experience with sporting activities (80). The activities will thus be 
adapted to allow participation for all children. 
b) Physical activity during school recess 
In primary schools, recess time amounts to almost 5 hours weekly and is a setting where young 
school children on average have a high level of PA (81). This makes recess an important part 
of the total daily and weekly amount of MVPA for young school children. It has been shown 
that improved facilities, both in terms of permanent play and sport facilities (e.g., climbing 
frames, football goals) and loose play equipment (balls, skipping ropes, skateboards), 
increases mean daily amount of PA among young school children as well as the proportion 
reaching daily recommended levels of MVPA (82,83). This part of the integrated PA 
intervention centres on distributing packages of loose play and sports equipment to school 
classes and making agreements with schools and teachers about how these are distributed 
and collected at the beginning and end of recess. Previous projects such as Move@School 
have shown this to be feasible and a popular approach for improving children’s opportunities 
to be active during recess. This will be supplemented by the concept of drawing lines in the 
schoolyards for 4-square and similar games and, if relevant, providing small goals for 
basketball, floorball and football.  
c) Physical activity in after-school clubs 
Danish school children at age 7-8 years spend about 10 hours a week in after-school clubs. 
Mean activity level is moderately high, but great variation is seen between children (81). More 

 
 
 
 
 
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physical activity in this setting will be facilitated by implementing policies limiting computer 
gaming as an activity and facilitating outdoor activities as much as possible.  In collaboration 
with the staff at the after-school clubs, activities suiting the institutional facilities and time 
structures will be developed and the equipment needed will be identified.  
6.3.2.3 Sleep and screen media habits  
During the study period, teachers/pedagogues will be asked to facilitate small assignments on 
screen media and sleep practices with the children during school time. The children will be 
asked to discuss and reflect upon screen media and sleep practices in their family, based on 
material from e.g., Medierådet (The Danish Media Council). The results of the children’s 
assignments will be presented at later workshops for the parents (see below in section 
6.3.3.2). This is done to integrate the children’s perspective in the parent workshops, 
especially in relation to screen media habits.   
6.3.2.4 Education of school staff 
School staff (teachers and pedagogues) involved with the 1st and 2nd grade classes at the 
intervention schools will be asked to participate in three courses in the beginning of the study 
period: 
Course on food and nutrition (approx. 4 hours): Teachers and pedagogues involved in 
preparation of the school food and having lunch with the children will receive education and 
material in e.g., the hygienic and pedagogical aspects of food and eating, nutrition, sensorics 
as well as tips and exercises to be used in the classroom.   
Course on PA (6 hours): The aim of the educational program for PE teachers and other 
teachers with responsibility of PA in the class is to develop children’s understanding, 
motivation, and abilities for being active in different sports and exercise activities throughout 
life. In many ways, the aim is to develop children’s physical literacy (PL). We aim to help 
schools and PE teachers fulfil the ambitious aim of PE by offering a short educational program 
developed and tested in the PE component of the Y-path program (84). PE teachers will be 
offered this short education in combination with peer supervision and sparring on how to 
support children’s PL development and how to create a motivating and inclusive climate for 
all.  
Course on children’s screen media and sleep habits (3 hours): Teachers and/or pedagogues 
with overall responsibility for the class will participate in an educational program related to 
children’s sleep and screen media habits. The educational program will inform teachers about 
evidence and recommendations on sleep and screen media habits, and examples of class 
exercises and activities for the workshops will be presented.   

 
 
 
 
 
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6.3.3 Interventions focused on the child through the family 
The interventions focusing on the child through the family will include fixed intervention 
components determined à priori by the research team, as well as co-created intervention 
components developed in collaboration with families.    
During the intervention period, up to four parent or family workshops will be held at the 
schools each year. The workshops will be used to convey important scientific knowledge 
within each of the project’s focus areas (diet, physical activity, screen media habits and sleep) 
to the parents. The workshops will also include practical exercises, such as inspiration for ways 
that parents can engage in physically active play with their children and/or tips and tricks for 
involving children in daily cooking. Furthermore, the workshops will be used to ask parents to 
provide their views on perceived individual-level and structural barriers for adopting healthier 
habits, and in collaboration with parents, we will co-create interventions which could support 
behavioural changes within each focus area. 
The form of each workshop will be decided in collaboration with the school. The workshops 
will be facilitated by members of the research team, teachers, pedagogues and/or external 
experts (such as Medierådet, Børns Vilkår, Hello Kitchen etc.), depending on the content of 
the specific workshop. Participants in the workshops may be parents alone and/or parents 
and children together. 
We will pay special attention to avoid lecturing, parent bashing, stigma, and unhealthy focus 
on body weight. Focus will be on actively engaging and involving parents in promoting 
healthier lives in their family and in the local community. To reach all parents irrespective of 
ethnic and educational background, we will provide simple messages supported by visuals, 
and we will translate material into numerous languages if recommended by the school. 
Written study material, such as invitations for workshops and inspirational material, will be 
sent to parents by e-mail via the software REDCap and/or via AULA and in print via the 
teachers. Inspirational material may include, for example, inspiration for birthday parties and 
playdates including fun physical activities that promote movement as well as suggestions for 
simple, fun and healthy food which we will develop together with the school and/or other 
stakeholders. The planned intervention components which involve the families within diet and 
sleep/screen media habits are described in more detail in the following sections. 
We will seek to actively include the children’s own perspectives in the development of certain 
intervention components. This will be done by conducting interviews and focus groups (class-
wise or in smaller groups) with the included classes in order to obtain the children´s 
perceptions of what constitutes a “healthy” life as well as barriers and facilitators for healthy 

 
 
 
 
 
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living. The data collection process will be guided by participatory action research methods, 
and we will use the research method “Future Workshops” where children are encouraged to 
establish their vision for a healthier school and local environment (112). We will seek to 
integrate the ideas and visions put forward by the children into the overall intervention 
program, where this is realistic and feasible.  
6.3.3.1 Diet  
At least one of the parent workshops held at the school during the intervention period will be 
used to provide motivation, tips, and strategies for healthier eating in the family. If feasible, 
there may also be cooking workshops for the families at the school, where families will be 
invited to cook with their children following simple and hands-on recipes to gain practical 
healthy food competences in the families.   
6.3.3.2 Screen media habits and sleep 
Based on the current knowledge of determinants of screen media habits in children, as well 
as our experiences in the family-based ‘SCREENS trial’ (57) and the ongoing school-based 
‘Screen-Free Time with Friends’, the intervention will mainly focus on the interpersonal- and 
institutional (school) level, i.e., the family and peer social networks (85,86).  
The overall aim of the screen media habits and sleep intervention component is to promote 
healthy screen media habits, encourage healthy sleep practices in the participating children, 
and to reduce the gap between the parents’ and child’s understanding of digital literacy.  
The intervention will contain fixed generic components such as facilitating class culture and 
providing parents with the latest knowledge and recommendations within sleep hygiene and 
screen media habits. 
Inspiration sheets 
All parents, (also those who have not provided consent on behalf of their child to participate 
in the study), will receive inspiration sheets introducing knowledge and recommendations 
about screen media habits and/or sleep, potential tools to address this knowledge as well as 
suggestions for child and parent activities to support dialogues about sleep and screen media 
habits between the children and parents. Through these inspiration sheets we seek to 
encourage parents to reflect and consider the sleep and screen media habits in their family. 
We will provide parents with tools they can choose to use to support the introduction and 
maintenance of e.g., screen media rules. Importantly, any specific screen media rules will be 
determined by the parents/family and not by the researchers. 

 
 
 
 
 
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Parent workshops on sleep and screen media habits 
Several parent workshops will be held over the two-year intervention period. The workshops 
will include recommendations, information, and dialogue focusing on children’s sleep and 
screen media practices. The workshops will focus on the assignments on sleep and screen 
media habits that children completed during school hours (see 6.3.2.3). 
The goal of the workshops is to increase parents’ awareness of their own and their children’s 
screen media practices, strengthen the dialogue with other parents, their own child, and 
between children within the provided subject (e.g., evening screen media use).  
The topic for the workshops is planned to be an introduction to the knowledgebase for the 
importance of better sleep and balanced screen media habits. The workshops will also focus 
on the exchange of experiences (pros and cons) with sleep and screen media habits at home 
and during child playdates among parents and reflections on potential strategies to support 
better sleep and screen media practices among the children during leisure time periods, in the 
family, and to increase the awareness of alternative leisure time activities (e.g., participation 
in after-school clubs, sports clubs).  
All parents will be invited to participate in the workshops even though they have not 
consented on behalf of their child to participate in the study.  
6.3.4 Intervention focused on the local environment 
The community intervention will be conducted in the local community surrounding eight of 
the 12 intervention schools (these eight schools are located in six different Danish 
municipalities).  
For four of the 12 intervention schools, there is a control school located in the same 
municipality. In order to avoid contamination between clusters, these four intervention 
schools will not receive the local community intervention.  
 
6.3.4.1 Local supermarkets, restaurants, and fast-food outlets 
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 (87–92). 

 
 
 
 
 
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Within the national partnership established in connection with the study (see section 6.3.1.), 
new solutions will be developed to promote healthier eating among children, e.g., decreasing 
portion sizes, improving the availability of fruit, vegetables, cold fresh water, and healthy 
snacks, and decreasing the availability of sweets and sugar-sweetened beverages in 
supermarkets, restaurants, cafés, fast-food outlets and local sports clubs. Priority will be given 
to increasing the availability of fruit and vegetables, including convenience products, to make 
cooking with vegetables easier. The local community partnership groups (LPCGs) established 
(see section 6.3.1) will have an important role in adapting and anchoring the interventions in 
the local setting. 
Furthermore, stakeholders from each of the selected local intervention communities will be 
invited into a co-creation process and to join the LCPGs. Invited stakeholders will be 
representatives from local sports organizations and other leisure time organizations for 
children, the school, the municipality, local supermarkets, restaurants and other private 
companies, parents, and other relevant local actors. The LCPGs will be responsible for 
developing and implementing activities within the local community that can promote 
healthier environments for children and families, including healthier food environment, easier 
access to active living including participation in sporting activities and outdoor activities, 
community-building activities etc. 
6.3.4.2 Sports organizations 
To support children that are not in sports clubs to join and become members, we will establish 
collaborations between schools, municipalities, and local sports clubs. Such collaborative 
initiatives have been shown to benefit families with low sporting experience, as these families 
are more positive towards sporting activities initiated via the school. Collaboration with sports 
organizations will occur in all 12 intervention schools, e.g. collaboration on establishing active 
summer camps during the summer holiday. 
6.3.5 Compliance 
Adherence to the intervention components will be explored at different levels using multiple 
method e.g., interviews, questionnaires, observations, logs, accelerometry, dietary 
registrations and biomarkers. As part of the evaluation of the implementation, we will assess 
whether the different intervention components are implemented by intervention providers, 
e.g., teachers and other pedagogical staff, as intended and to what extent (dose delivered). 
Moreover, we will explore to what degree children and parents are exposed to the 
intervention component (dose received and reach). We will also explore participation in 
general. 

 
 
 
 
 
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6.4 Control schools 
The control schools will be offered education related to physical activity (FIT FIRST teen) for 
teachers of the eldest classes in the school, and all children in the classes participating in the 
present study will be offered participation in an activity day by the end of the study period. 
Also, as in the intervention schools, participating children will receive a small gift at each 
measurement round (see section 9). 
6.5 Overview of study procedures and activities 
The table below summarizes the activities described above and provides an overview of the 
planned study procedures as well as measurements, which will be conducted in 3 test rounds 
i.e., at the beginning of the first school year and at the end of each of the two school years. 
The measurements will be further detailed in section 6.6. 
Table 1. Overview of study procedures and activities 
August–
September 2023  
Initial contact  
• Invitation letters and participant information are distributed to 
parents / custody holders  
August–October 
2023  
Information meetings at the school   
• An understandable presentation of the context and purpose of 
the study  
• An understandable explanation of the study interventions and 
measurements to parents and children.  
• Description of rights and considerations before decision  
• Description 
of 
foreseeable 
risks, 
adverse 
events, 
complications, and inconveniences  
• Unpredictable risks  
• Voluntary participation and right to withdraw at any time  
• Review of pamphlet “Before you decide” (11.NVK marts 2019)  
• Information regarding handling of personal data / biological 
material, confidentiality, and general compliance with The 
European 
General 
Data 
Protection 
Regulation 
/ 
Databeskyttelsesforordningen. 

 
 
 
 
 
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• That all data collected during the participation in the study will 
be used in the event of a participant chooses to withdraw from 
the study 
• The right to time for reflection  
• Questions  
• Explanation of informed consent and withdrawal  
• Collection of informed consent (including the possibility for 24 
hours of consideration time) 
• Evaluation of inclusion/exclusion criteria including the allergy 
questionnaire  
Staff education 
• Courses at schools – an education program for teachers and 
related staff involved in the intervention (see section 6.3.2.4) 
Preparation of measurements  
• Instructions 
on 
dietary 
recording 
and 
accelerometer 
measurement  
Round 1: 
September-
November 2023 
(baseline) 
 
+ 
 
 
Round 3:  March-
June 2025 
(endpoint) 
Measurements at home:  
• Three-day dietary record, app. 30 min/day 
• Accelerometry 
• Screen time 
• Questionnaires  
• Adverse events 
Measurements in school:  
• Height, weight, and waist circumference 
• Body composition (BOD POD and bioimpedance) 
• Blood pressure and resting heart rate  
• Mounting of accelerometer device  
• Cognitive functions and school performance (math and 
reading) 
• Aerobic fitness, muscular fitness, strength and sprint 
performance (Yoyo running test, handgrip strength and sprint 
test) 

 
 
 
 
 
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• Motor function tests (balance, vertical jump, , agility, gross and 
fine motor function) 
• Well-being and quality of life questionnaire 
• Food literacy questionnaire 
• A questionnaire assessing motivation, confidence, and 
knowledge in relation to physical activity   
Round 2: April-
June 2024 
 
Measurements at home:  
• Three-day dietary record, app. 30 min/day 
• Screen time 
• Questionnaires  
• Adverse events 
Measurements in school: 
• Fasting blood sample and time for breakfast (only children in 
DK-East, see below section 6.6.3.3) 
• Height, weight, and waist circumference/ 
• Body composition (bioimpedance) 
• Blood pressure and resting heart rate 
• Aerobic fitness, muscular fitness, strength and sprint 
performance (Yoyo running test, handgrip strength and sprint 
test) 
• Well-being and quality of life questionnaire 
• Food literacy questionnaire 
 
October 2023 to 
June 2025  
Activities in school and in the community  
• School lunch 4 times per week  
• Tips and inspiration for parents on making healthy midmorning 
snacks and possibly lunch 
• 3x40 minutes of organized vigorous PA per week in school. 
• PA in breaks and after school clubs. 
• Inspiration sheets for families on screen media habits, sleep 
and dietary habits etc.  

 
 
 
 
 
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• Tips and inspiration for staff in after-school clubs on how to 
follow the national food-based guidelines  
• Cold-water dispensers, if relevant  
• Parent workshops at the school 
• Workshops, focus groups and interviews with children 
• Assignments / exercises for children during school time about 
screen media habits, sleep, nutrition and food competences 
• In the local community surrounding eight intervention schools 
(six municipalities): Workshops with local stakeholders and 
establishment of local community partnership groups. 
Other  
• School staff education  
• Packages of loose play and sports equipment for school classes 
• Community events 
• Fieldwork, interviews, focus groups, logbooks, and short 
questionnaires for e.g., children, parents, school staff and local 
stakeholders 
• Observations 
 
6.6 Measurements and study procedures 
As mentioned, measurements will be conducted in 3 test rounds i.e., at the beginning of the 
first school year and at the end of each of the two school years. Each measurement will be 
conducted in all 3 rounds, unless stated otherwise below. 
 
6.6.1 Questionnaires to be filled in at home  
The questionnaires will be administered via text message and e-mail with a link to the 
electronic survey to parents. All questionnaires will be offered in Danish, but participants can 
choose an English version for some of the questionnaires. 
The following questionnaires will be administered: 

 
 
 
 
 
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• Family background (round 1 or at round 2, 3 or at new enrolments if not answered at 
previous data collection rounds): Data on children’s SES will be collected from the 
parent(s) or legal guardian(s) using the Danish Occupational Social Class Measurement 
(93) (appendix 10). 
• Sun habits (vitamin D) (in appendix 10) 
• Child’s leisure time sports participation (in appendix 10).  
• Pubertal stage (round 1 and 3) (appendix 11-12). 
• Food allergies (only intervention schools), plaster allergies, and chronic disease 
(Appendix 2A for intervention schools and 2B for control schools)  
• Neurodevelopmental disorders and medical conditions (in appendix 2A and 2B) (at 
round 1 or at round 2, 3 or at new enrolments if not answered at previous data 
collection rounds). 
• Breakfast consumption, intake of beverages, fish, and dietary supplements (appendix 
13). 
• Wellbeing & Quality of Life: Children’s well-being will be measured by Strengths and 
Difficulties Questionnaire (SDQ) (appendix 26). As no valid measure exists for children 
under age 11, this parental questionnaire will be used to supplement child-reported 
well-being.  
• Child and parent screen time, type and current screen time practices will be collected 
using the modified parent reported SCREENS questionnaire (95) (appendix 15).  
• Child quality of sleep will be measured using the Children’s Sleep Habits Questionnaire 
translated to Danish (96) (appendix 16).   
• Family grocery shopping habits (round 1 and 3, only for parents in the six intervention 
communities where the expanded local community intervention takes place) 
(appendix 25)  
• Perception of the project and the activities (see section 6.6.4). 
• Adverse events and concomitant medicine (round 2 and 3) (appendix 17). 
• Drop-out questionnaire (at dropout) (appendix 3). 
6.6.2 Other procedures at home 
6.6.2.1 Dietary records 
Children’s daily intake of food and drinks will be recorded by the parents for three consecutive 
days (two weekdays and one weekend day). We will use the validated, web-based tool, 
myfood24, which uses data from the national food composition tables. The tool is user-
friendly, suitable for the target group and recording links can be sent via email.  

 
 
 
 
 
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6.6.2.2 Screen time measurement  
At baseline, we kindly ask the parents to install a research-based app, Ethica 
(https://ethicadata.com), on the participating child´s own smartphone and/or tablet. At all 
test rounds, we will use Ethica to collect information on screen time usage and screen time 
patterns over a period of 14 days. After installation, the app runs automatically in the 
background. The app has been developed to meet legal requirements for data security.  
6.6.2.3 Physical activity and sleep assessments (Axivity)  
Detailed, objective information on the whole spectrum of behaviours will be assessed by 
continuous 24-hour/7-8-day Axivity® accelerometer measurement using thigh positioned 
monitors in rounds 1 and 3. Using the thigh measurement position the modified age-adjusted 
method of Skotte et al. (97) provides the ability to classify postural allocations like sitting, 
standing and activities like walking and running with high sensitivity and specificity in children 
(98). Time lying in bed and sleep time will be objectively measured using an accelerometer 
classification algorithm that is currently under development. 
The Axivity® AX3 monitor is a small (23 x 32.5 x 7.6 mm), lightweight (11 g), waterproof, 3-axis 
accelerometer data logger (Axivity, 2016). The Axivity® AX3 will be attached to the skin using 
thigh belts developed by a Danish company (Elas) or tape (Opsite Flexifix®, Fixumull®) directly 
on the body using compress (gaze) or artificial skin (DuoDerm) between the monitor and the 
skin. We have good experience with both methods attaching the Axivity® AX3 monitor to the 
body, but using plaster is more time consuming so we need to find out which method is most 
feasible in the study. The monitors will be attached at the school. All observers/staff in contact 
with the children will undergo pedagogical and professional training in the tests and in carrying 
out the measurements with the children and in adherence with Danish law have the necessary 
criminal records bureau check. It is important to ensure that the children also give their assent 
to participate in the study, if their parents have provided a written consent allowing them to 
participate. During the study period we will be aware of the children´s reactions and whether 
they feel comfortable or not with the test situations. If the children do not want to wear 
accelerometers, we will respect this. Children with plaster allergy, childhood eczema or 
sensitive skin will always be offered to use belts. The children or parents will receive an 
information leaflet to take home or on the parent email including relevant information 
regarding the physical activity measurement.6.6.3 Measurements in school 
Two program centres (UCPH in DK-East and SDU in DK-West), with specially trained test teams, 
will be responsible for the measurements in the schools. The measurements in school will be 
spread over 1-3 days for each child. That is, the measurements will have a maximum duration 
of three school days for each child in each round. To provide some flexibility, it is possible to 

 
 
 
 
 
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move the tests of Danish spelling, reading and mathematics proficiency to a separate day 
(without the maximum duration is exceeded). 
6.6.3.1 Measures of anthropometry including height, weight, and waist circumference 
The children will be weighed once in underwear/light clothes on a digital scale. Standing 
height will be measured three times to the nearest millimetre with a stadiometer. Waist 
circumference will be measured three times to the nearest millimetre by a non-elastic 
measuring tape at the level of the umbilicus. The mean of three measurements will be used 
for height and waist circumference. 
6.6.3.2 Body composition and blood pressure 
Body composition (i.e., FM and fat free mass) will be measured by air-displacement 
plethysmography using a BOD POD in round 1 and 3 and a bioimpedance weight (InBody 270). 
The children will be wearing underwear/light clothes and a bathing cap. The children must sit 
in a transparent capsule for approximately 5 minutes (BOD POD). The bioimpedance 
measurement takes approximately 1 min.  
Blood pressure and resting heart rate will be measured three times by an automated device 
while the child is lying down after 10 minutes of rest. The appropriate cuff size for the child’s 
arm circumference will be used.  
6.6.3.3 Blood samples 
Blood samples will only be collected from children in DK-East (12 schools). This is due to logistic 
and budgetary reasons, and furthermore, power calculations show that blood sampling from 
children in 12 schools will provide us with sufficient statistical power for the study outcomes 
that are measured in blood samples (see power calculation in section 6.1.4). Therefore, we 
consider it as an important ethical consideration that blood samples are only obtained from 
the statistically sufficient number of children. All parents and children will follow the same 
informed consent procedure in accordance with the Committee Act, regardless of whether 
blood samples are obtained (see sections 6.2.5.1-6.2.5.6).  
Blood samples will be collected in the overnight fasted state (except water) only from children 
in DK-East. The children can have breakfast shortly after the blood samples have been 
collected. We will instruct the parents to provide the children with a breakfast pack on the 
blood sampling day but will also have food available for children that do not have any. The 
children will be provided with local anaesthetic patches (EMLA or similar), which the parents 
will be instructed to apply on their child’s arms in the morning (appendix 18). After removal 
of the patches, max. 30 ml blood will be drawn from the child’s forearm by trained laboratory 

 
 
 
 
 
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technicians. The blood samples will be brought back to University of Copenhagen for 
processing and storage at –70oC until analysis.  
6.6.3.4 Health related fitness and motor functions  
Aerobic fitness and intermittent exercise performance will be evaluated by the Yo-Yo 
Intermittent Recovery Level 1 Children’s test (80), where the children will have to run 2x16m 
at increasing speed with 10 s break between each run. The test continues until the children 
cannot reach the finish line in time and takes around 20 min. for up to 50 pupils, depending 
on the size of the indoor gym. Heart rate will be measured continuously during the test, to 
determine endurance capacity and maximal heart rate. The test is simple and validated for 
fitness and maximal heart rate assessment for 6-10-year-old children (99). Heart rate and 
locomotor activities will also be measured during selected physical activities throughout the 
study period to describe the intensity. 
Muscular fitness, strength and sprint performance will be determined by the hand grip 
strength test and a 20-m sprint test. The hand grip strength test is conducted with a hand grip 
dynamometer. The child squeezes the dynamometer with all their strength, two times with 
each hand. An average score is then calculated using the measurements from both hands. 
Sprint time is measured by photocells. The children will complete each test twice and will be 
instructed to use all their power.  
In rounds 1 and 3,gross motor functions are assessed as static and dynamic balance ability, 
upper extremity gross-motor function, jump height and agility. Jump height and balance 
ability are measured on a force plate measuring the vertical ground reaction force. Jump 
height is measured during the vertical countermovement jump test. Balance ability is 
measured during one-leg maintained balance and as maximum reaching ability during 
maintained balance, Agility is measured as time to complete an agility running exercise with 
different motoric tasks. Time to completion is measured by photocells. The children will 
complete each test twice and will be instructed to use all their power. Upper extremity gross-
motor function is tested as speed and accuracy in the ability to perform accurate, goal-
directed reaching movements towards a number of visually displayed targets within 30s or 1 
minute.  
6.6.3.5 Test of cognitive functions and school performance 
In rounds 1 and 3, the children will complete a short battery of standardized, validated and 
age-appropriate neurocognitive tests (100,101) including tests of executive function, memory, 
and attention. The tests resemble computer games, and they are administered individually via 
a tablet or iPad.  In addition, school performance will be assessed by use of standard and age-

 
 
 
 
 
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appropriate tests of Danish spelling, reading and mathematics proficiency (100,102). We have 
good experience administering these methods in a school setting and for children at this age. 
6.6.3.6 Wellbeing & Quality of Life: KIDSCREEN 27  
Children’s well-being will be measured using KIDSCREEN 27 (appendix 14). This validated 
questionnaire consists of 27 items that measure five dimensions of children’s quality of life 
and well-being. These are physical well-being, psychological well-being, relationship with 
parents, relations to peers & social support, and life quality in the school environment (94). 
Due to the respondents’ low age and inability to read, a video and speech assisted child 
version of these questionnaires will be developed. The children will fill in this questionnaire 
using tablets and headphones enabling all items of the questionnaire to be read aloud, while 
the text appears on the screen. The answer scale points are illustrated with smileys.  
To assess pupils’ psychological well-being and functioning during school-based intervention 
activities, basic psychological needs satisfaction and intrinsic motivation is measured acutely 
right after occurrences of the school intervention activities. Satisfaction of children’s three 
basic psychological needs for experiencing relatedness; - competence and autonomy as well 
as intrinsic motivation - will be measured with 3 items each adapted from Basic Psychological 
Needs Scale (BPNS-R) for PE (103) and the Intrinsic Motivation Inventory (104,105) adapted 
to the age-group and context (Appendix 18). A smiley based 4-point answer scale will be used. 
To assess the motivational climate during intervention activities, systematic observations and 
scoring of indictors of empowering (task-orientation, relatedness support and autonomy 
support) and dis-empowering climate (ego-orientation and controlling behaviour) will be 
collected during intervention activities.  
6.6.3.7 Motivation, confidence, and knowledge in relation to physical activity  
In rounds 1 and 3, a Danish video-assisted questionnaire, MyPL questionnaire, validated for 
children down to 7 years of age will be used to measure children’s intrinsic motivation and 
confidence for physical activity as well as their knowledge and understanding of physical 
activity. The MyPL is a 20-item physical literacy assessment tool that strives to account for 
how the domains of physical literacy (motivation, confidence, physical competence, and 
knowledge in relation to physical activity) differs across different social and physical 
environments for physical activity, as described in the conceptualization of physical literacy by 
Whitehead (113). This structure makes it cognitively easier for the children to think about and 
thus answer. It consists of five subscales reflecting context and discipline-specific motivation, 
confidence, and knowledge for physical activity. The children will fill in this questionnaire using 

 
 
 
 
 
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tablets and headphones enabling all items of the questionnaire to be read aloud, while the 
text appears on the screen and introduction supported by pictures (Appendix 19).   
The children will also be asked about their participation in leisure time sports club activities 
(Appendix 20).   
6.6.3.8 Food competences and meal culture 
Children’s food competence and meal culture will be assessed using a self-constructed 
questionnaire developed for and validated in the age group (Appendix 21). 
6.6.3.9 Registration of snack and lunch consumption 
On selected days, portion sizes and food/beverage intake at breakfast, midmorning snack, 
lunch and afternoon snack in schools/after school clubs will be recorded at class level in a 
subsample of the schools. Also, teachers/pedagogical staff present in the classes during the 
children’s consumption of lunch will be asked to roughly assess and register the intake of this 
meal at class level.  
6.6.4 Evaluation of measures related to implementation of the intervention and 
organizational aspects 
To explore acceptability, perceived outcomes, and consequences of the intervention, as well 
as structural and organizational aspects related to implementation of the intervention, school 
management at each school, and/or other relevant personnel with coordinating/managerial 
responsibilities related to this project, will be asked to complete questionnaires and to 
participate in interviews. Moreover, all teachers and/or other relevant pedagogical staff, 
affiliated with the various intervention components, will be asked to complete surveys and to 
participate in interviews. Interviews, focus groups and brief surveys (Appendix 23 and 24) will 
be conducted with children in order to investigate the children’s perceptions of the 
Generation Healthy Kids program components, as well as how the intervention influences 
children’s perceptions of concepts such as health, body and well-being. Field work during 
school hours, e.g., classes, PA sessions, recess, and lunch with focus on how the intervention 
unfolds in practice, reasons for adaptation, and participant responsiveness will be conducted 
via observation methods etc. In addition, we will conduct process evaluation fieldwork 
(observations and on the spot interviews) in relation to measurement days at baseline to 
explore how the children respond to and experience the measurements. 
Parents will be asked to participate in interviews and to complete questionnaires regarding 
perception of the project and the activities. Moreover, PE teachers are asked to roughly assess 

 
 
 
 
 
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and register attendance and active participation during the 3x40 minutes sessions of PA at 
class level. Local coordinators will be asked to register the number of parents who attend 
school events, to explore implementation and perceived outcomes of the intervention. 
Moreover, fieldwork will be conducted when possible. 
To explore relevant structural and organizational aspects as well as initiatives focusing on diet, 
physical activity, screen time and/or sleep in the control schools, the school management at 
each control school will be asked to complete a (few) questionnaire(s) and participate in an 
interview. 
6.6.5 Measurements at further school, community, and national level 
During the study, we will track the implementation and stakeholder engagement. 
Implementation data will include a register of activities in each local community, a database 
of stakeholder engagement and key engagement activities. Data will be collected on a regular 
basis and use methods recently described by Maitland et al. (107).  
Furthermore, we may collect structural data on food environments, including accessibility and 
spatial layout of stores, using digital maps, GIS data (e.g., Smiley register), field studies  and 
sales data from supermarkets (90). 
We plan to conduct both a) interviews with the manager of the after-school club and 
facilitators of activities in the leisure time clubs and the active summer holiday camp as well 
as b) systematic observations on selected days to explore acceptability, perceived outcomes 
and consequences of these intervention components. Moreover, we expect that actors 
involved in the implementation of intervention activities, e.g., schoolboard members, 
managers of after-school club, volunteers in leisure time clubs, will be asked to fill out 
questionnaires and/or take part in interviews exploring structural and organizational factors 
influencing implementation. Several core theories, models and frameworks within 
implementation science will serve as reference points for the mentioned investigations. 
We will measure local and national partnerships using the Danish translation of the VicHealth 
partnerships analysis tool (108). Furthermore, this tool will be adjusted and adapted to the 
current project inspired by the work done by Indig et al. (109).  
6.6.6 Use of the school’s recordings of children’s absence 
As an indicator-measure of intervention effects on the children’s general health and school 
wellbeing, we will seek to obtain the schools’ recordings of children’s attendance and absence, 

 
 
 
 
 
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by parental consent.6.6.7 Amendments regarding parental questionnaires and dietary 
records in measurement round 3 
The project is facing a methodological challenge, as we have seen a drop of approximately 
30% in the response rate from first measurement round (conducted in September-  November 
2023) to the second measurement round (conducted in April-June 2024) in the previously 
approved parent-administered assessments i.e. the parent background questionnaire 
(consisting of appendix 10, 11, 12, 13, 15, 16, 14, 25 and 26) and the 3-day dietary records 
(described in section 6.6.2). 
A further drop in the third and final measurement round (scheduled for March-June 2025) 
could result in a ccompromise the validity and integrity of the results, and significantly reduce 
the statistical power and generalizability of the findings.  
The response rate of the parent background questionnaire decreased from 86.0% to 50.6% 
and the response rate for the 3-day dietary records the response rate has gone from 83.6% to 
59.7%. Furthermore, parents of children in intervention schools also received an evaluation 
questionnaire (described in section 6.6.4) at measurement round 2. The response rate of the 
evaluation questionnaire was 38.9%. 
It is widely recognized that encouraging participants to respond to questionnaires can be 
challenging. During the third and final measurement round, we anticipate that participants 
will be less focused on the intervention compared to the first and second rounds, as the 
intervention will have become routine for them. Research has demonstrated that various 
incentive strategies effectively increase response rates (112, 113). Therefore, we will use 
different incentives to motivate parents to complete the mentioned three parent-
administered: the 3-day dietary records, the parent background questionnaire, and the 
evaluation questionnaire. 
 
6.6.7.1 Procedures for increasing response rate  
The following steps will be used; 
1) Posters and Flyers:  

 
 
 
 
 
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We will put up posters and hand out flyers (appendix 28 and appendix 29) at the schools to 
remind parents to answer the parent-administrated assessments. Posters will be displayed 
around classrooms, and flyers will either be handed directly to parents or sent home in 
children's school bags.    
2) Activity Overview: 
We will provide an overview of all activities related to the final measurement round, offering 
clarity to both children and parents. We hope this will increase the parents' awareness of 
parent-administered assessments. This will be sent by mail.  
4) Personalized reminders: 
Personal relationships and direct communication have been shown to be effective in 
increasing response rates in survey studies (112, 113). On this basis, we will personalize the 
reminders to the parents who participated at baseline but have not yet completed the 
background questionnaire during the final measurement round (appendix 32 and appendix 
33).  
 
This group is considered particularly important, as their prior participation at baseline 
indicates a level of commitment critical to achieving a high response rate in the third and final 
round of data collection. 
The purpose of this communication would be to acknowledge their participation in the 
baseline survey (September-November 2023) and encourage them to take part in the third 
and final measurement round. 
5) Lottery Prizes: 
We will introduce lottery prizes for those who complete the parent-administrated 
assessments. Lottery prizes are known to be an effective tool for increasing response rates 
(Edwards et al., 2023). These prizes will not influence the decision to participate in the study, 
as they will only be available to those already enrolled and relate to questionnaires and dietary 
recordings that have been part of the study from the start of the project. To ensure the prizes 
are relevant to the whole family and to clarify the chances of winning, families will have the 
opportunity to win four cinema tickets. 
A total of 100 prizes will be awarded, each prize will have a maximum value of 600DKK. 
Participants will earn one lottery entry for each completed parent-administrated assessment, 
which includes the following: 

 
 
 
 
 
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• 3-day dietary records: One lottery entry will be awarded for each completed day of 
dietary recording, for a total of up to three entries if all three days are completed. 
• Parent background questionnaire: One lottery entry will be awarded upon 
completion. 
• Evaluation questionnaire: One lottery entry will be awarded upon completion. 
To ensure fairness, two separate lottery pools will be established: one for parents of children 
at intervention schools and another for parents of children at control schools. This distinction 
ensures fairness, as only intervention school parents must complete the evaluation 
questionnaire. Parents at control schools can earn up to 4 entries, while those at intervention 
schools can earn up to 5. 
Each participant will be able to win once. The probability of winning will be equalized between 
the two pools, based on the number of participants at measurement round 3.  The winners 
will be found using a random number generator, that will generate 100 unique winners based 
on the extraction from RedCap. 
The probability of winning is estimated to be approximately 7.3%. This is calculated based on 
the number of participants enrolled in the study. 
Parents will be informed about the lottery via email (see Appendix 30 and Appendix 31). In 
accordance with the Danish Marketing Practices Act, the terms and conditions of the lottery 
will also be provided in the email and reiterated in the messages accompanying the 
questionnaires and 3-day dietary records. 
If a parent does not want to enter the lottery, they can inform of about this by email and we 
will not include them in the lottery (the deadline for this will be based on the exact date of the 
lottery. Parents will be informed through the terms and conditions of the lottery). 
6.6.7.2 Ethical considerations in relation to strategies to increase response rate 
General ethical considerations related to increasing parental response rates emphasize the 
importance of high-quality data for the credibility of research findings. The initiatives 
described aim to enhance response rates without compromising consent or participation. We 
emphasize that the initiatives described below do not affect participant consent, as they 
exclusively target parents who have already consented to participate in the research project. 
Our sole aim is to increase response rates within this group. No new measurements or 
questionnaires will be added. High response rates ensure that findings accurately reflect 
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participating families. From an ethical standpoint, poor data quality may lead to unreliable 
conclusions, diminishing the study's value. 
Our ethical considerations regarding the different initiatives are as follows:  Flyers will only be 
distributed to parents who have already consented to participate in the research project, and 
posters will be directed at parents whose children are already participating. The possibility of 
entering a prize draw will not be mentioned on the posters or flyers to avoid influencing the 
decision of parents and children who are not yet enrolled. Providing a clearer overview of the 
measurements is not considered to raise significant ethical concerns, as it solely aims to 
inform the participating parents. It is ethically justified to use incentives to increase response 
rates (112, 113). The prize lottery is restricted to already enrolled participants and therefore 
does not affect consent.  Personal reminders will focus on the importance of completing 
questionnaires rather than specific responses. However, care will be taken to avoid excessive 
messaging and to ensure participants do not feel monitored, preserving their right to 
anonymity.   
Thus, we believe that these strategies are ethically justified as they aim to enhance data 
quality and scientific value without compromising participant autonomy or consent.  
6.7 Adverse Events 
Adverse events (AEs) will be registered during the intervention. At each round of 
measurements, parents/custody holders will be asked by questionnaire if their child has had 
any AEs or reactions and any new medicine or changes in dosage taken since the last 
measurement as well as the start and end date (Appendix 17).  In addition, parents will be 
asked to contact us if any events or reactions occur. The medically responsible physician will 
evaluate and record the intensity, causality, actions needed and outcomes of reported events.  
6.8 Handling of biological samples   
6.8.1 Sample analysis 
Biological samples will mainly be analysed at University of Copenhagen, Denmark. Samples 
could also be analysed at other laboratories within and outside the EU, when this is judged 
necessary for the quality of the analyses. Therefore, it is not possible for researchers to predict 
in advance where analyses will be carried out and by whom. If data is transferred to countries 
outside EU to a country which cannot ensure an adequate level of protection, the transfer will 

 
 
 
 
 
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be in accordance with chapter V of the GDPR. Parents will be informed that their data may be 
sent to data processors in a country like these if this is necessary for the quality of the overall 
result of the study. They are also informed that their data will be sent as 
pseudonymised/coded data and that the transfer will comply with the GDPR.   
Parents will be informed separately about the handling of the data and all data transferring 
will be in accordance with GDPR.  
The processing of data and biological samples in the project and at external data processors 
will be recorded at the mandatory lists to the Danish Data Protection Agency, and all data 
processing will follow GDPR/Databeskyttelsesforordningen and Databeskyttelsesloven. Data 
set and samples will always only be sent to data processors in coded s without any 
accompanying data that could potentially identify the participants.   
Table 2 gives an overview of the planned analyses of the biological samples.  
Table 2. Biological sample analyses – blood   
Biomarker field 
Analyses  
Compliance 
& 
nutrition 
biomarkers  
• Fatty acids, lipids and other nutrient biomarkers  
• Alkylresorcinols (wholegrains) and other food biomarkers  
• 25-hydroxyvitamin D, vitamin D binding proteins and -
metabolites   
• Haemoglobin, ferritin, and transferrin receptor (iron)  
Growth 
& 
development 
• IGF-I, IGFBP-3 and other growth factors 
• Osteocalcin, bone specific alkaline phosphatase and other 
bone markers  
• Parathyroid hormone 
• Sex hormones 
Cardiometabolic 
• Triacylglycerol and total, LDL and HDL cholesterol and others 
• Glucose, insulin, C-peptide, glycosylated hemoglobin (HbA1c) 
etc. 
Appetite 
• Appetite hormones 

 
 
 
 
 
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Inflammation 
• C-reactive protein, cytokines, adipokines, and related markers 
• Immune cells and immune markers 
Cognition 
• Blood markers related to brain function such as brain-derived 
neurotrophic factor (BDNF) and serotonin  
Mechanisms 
• Metabolomics, proteomics and lipidomics 
• Short chain fatty acids and other metabolites 
Genetics 
• Genotypes and epigenetics related to the study outcomes and 
research questions (single nucleotides polymorphisms and 
genome wide association studies, NOT full genome 
sequencing, and epigenetics) 
 
6.8.2 Genotypes and epigenetic analyses 
Gene polymorhisms and epigenetic analyses will be used to investigate biological mechanisms 
and effect modifications, as described in section 5.2.2. We will only investigate genes related 
to the exposure variables and study outcomes, e.g. involved in nutrient status, growth and 
body weight, metabolism, cognitive function etc. Genotyping will not include any full genome 
or exome sequencing, but will either be performed by DNA microarray (such as the Illumina 
Infinium HumanCoreExome Beadchip), that gives information on common gene variants 
(>5%), or by targeted analysis of common single nucleotide polymorphisms. It is therefore 
considered highly unlikely that we will identify any genetic variants that have any direct 
relevance for illnesses. 
6.8.3 Research Biobank 
In relation to the planned analyses in this study, a research biobank will be created at 
Department of Nutrition, Exercise and Sports, University of Copenhagen for storage of blood 
samples. The research biobank will include maximum 3 x 30 mL = 90 mL of blood from each 
child. 
The research biobank is registered at University of Copenhagen. Biological material will be 
stored at maximum -70 C in the research biobank until analysis is completed and will be 
destroyed no later than 10 years after last participant last visit (June 2035), unless custody 

 
 
 
 
 
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holders have signed a separate consent form that eventual remains can be transferred to a 
biobank (see 6.7.3).  
All personal data/biological material is handled with confidentiality and stored in accordance 
with applicable law, GDPR and Danish Data Protection Act. no. 502 of 23rd May 2018. 
6.8.4 Biobank for future research purposes 
Eventual remains of material of blood (maximum 3x 20 mL=60 mL) from the research biobank, 
will, if the custody holders of participants have signed a separate consent form for this, be 
transferred from the Research Biobank to a biobank at University of Copenhagen. The biobank 
material will be stored at maximum -70 C at the Department of Nutrition, Exercise and Sports, 
University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C. The biological samples in 
this biobank will be stored for a maximum of 20 years after last participant last visit (June 
2045) and will only be used in new research projects after these have been approved by the 
Danish Regional Committee on Biomedical Research Ethics, unless the samples have been 
totally anonymized, in which case they will be stored longer. Anonymization means that the 
ID-log that connects study participants and the ID on the biological material has been 
destroyed and it is no longer possible to identify the participant. If the study participants or 
custody holders of participants choose to donate remains of biological material from the 
research biobank to the biobank and later regret it, they can contact the Department and have 
the samples destroyed if the samples have not been anonymized.  
The PI knows that establishment of a biobank for future related research projects of the excess 
material from the research biobank is not covered by the committee by law, but by the 
General Data Protection Regulation (Databeskyttelsesloven/ Databeskyttelsesforordningen). 
As the procedure is considered relevant for the entire research protocol in Denmark and to be 
able to prove that the biobank is established on a legal basis, the information is included in 
the material for the ethical committee. 
6.9 Data Management and Quality Control 
6.9.1 Data Collection and Processing 
All collected data will be stored in accordance with the General Data Protection 
Regulation/Databeskyttelsesforordningen for data handling. 

 
 
 
 
 
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6.9.1.1 Data storage in REDCap 
Data from questionnaires and most outcome data collected during school measurement days 
will be collected and stored directly in REDCap, which is a secure platform for building and 
managing online surveys and databases. REDCap is managed by the researcher service 
organization OPEN in the Region of Southern Denmark.  
Research personnel will collect and enter data following formulated standard operating 
procedures. Data quality will be ensured using tailored validation fields in REDCap. 
6.9.1.2 Data storage on other platforms 
Outcome data (smartphone use, cognitive tests and dietary record) will also be stored on 
online servers provided by external companies (Ethicadata, Cambridge Cognition, MyFood24). 
We will establish data handling agreements with the companies to ensure that data is securely 
and not used for other purposes. 
Data from heart rate monitors (collected during the fitness test) will be extracted and stored 
pseudonymised in safe folders on university servers at SDU or UCPH. 
Accelerometers will be collected at the schools (after 7-10 days) and transported back to the 
University of Southern Denmark or University of Copenhagen where data will be extracted 
from the measurement devices and stored in safe folders on the University servers. 
Collected blood samples will each day be transported back to the University of Southern 
Denmark or University of Copenhagen where they will be processed and stored at maximum 
–70 degrees Celsius until analysis.  
Process data such as field notes, observations, logbooks, and interviews, which will be 
collected in paper form or recorded, will be entered and stored in safe folders on university 
and/or region servers at SDU and/or Center for Clinical Research and Prevention. 
Aggregated datasets from all data storage platforms other than REDCap will be stored in the 
REDCap file repository. The aggregated datasets will be uploaded to the REDCap file repository 
and include the ID log variable to allow for combination of the datasets. 
6.9.2 Confidentiality 
To maintain confidentiality, participants will only be identified by their initials and an assigned 
participant number. Documents that identify the participant (such as the signed informed 
consent document and the ID log) will be maintained in strict confidence by the investigator, 

 
 
 
 
 
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except to the extent necessary to allow auditing and/or monitoring by the appropriate 
regulatory authority. All information obtained during the study will be handled according to 
local regulations and the GDPR/Databeskyttelsesforordningen. The study is registered on a 
central list at the Institutions/UCPH and SDU. The universities conduct lists of all data 
controllers/data processors and their handling of the personal data, and the lists are available 
in case of inspections from the Danish Data Protection Agency. 
6.9.3 Information/data from patient hospital records 
Data and information from the participants’ Hospital medical records will not be included in 
this project. 
6.10 Use of data from Danish registers 
We will obtain information on eligible children and their families from Danish registries with 
the purposes to 1) obtain contact information (name, address, and CPR-number) on eligible 
children and their parents (for distribution of all participant materials  related to the study), 
2) compare socio-demographic characteristics (parent education and employment) of 
participants with eligible non-participants to better judge generalizability and explore this 
analytically, 3) investigate the long-term (i.e., a 7-year follow-up) effectiveness of the program 
on body composition, and 4) lower the burden of the parental survey with respect to 
sociodemographic information, and 5) limit missing information on sociodemographic 
information due to survey non-response. Registries that will be used for these purposes 
include at least the following: The Civil Registration System (Det Centrale Personregister), The 
National Child Health Register (Børnedatabasen), and the DREAM database.  
In the participant information (Appendix 5A and 5B), we inform all parents that we plan to 
collect information on the above-mentioned factors from Danish registers on all eligible 
children regardless of whether consent to participation in this project has been obtained or 
not. The Legal authority for said collection of data will be Section 10 in Databeskyttelsesloven 
and Article 6 (1) (e) of General Data Protection Regulation  
Furthermore, we will obtain information from Danish national health registers and clinical 
databases, e.g., the National Patient Register, the National Prescription Register, the National 
Health Services Register, the Danish Psychiatric Central Register, the Medical Birth Register, 
and the National Child Health Register, to study associations between lifestyle factors and 
biomarkers collected in the study and subsequent long-term health and morbidity among 
participants. Such registry linkages will be performed for up to 10 years after last participant 
last visit (June 2035) to be able to passively follow the cohort during adolescence and 

 
 
 
 
 
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adulthood, and thereby study early childhood determinants of later health and morbidity. All 
registry linkages will be performed on secure servers at Statistics Denmark or the National 
Board of Health Data, and all data sets will be pseudonymized before analysis. 
The establishment of a database containing data from this project as well as the subsequent 
transfer of data for related future research projects are not covered by the Danish Committee 
Act. Rather, for said actions, PI must comply with the General Data Protection Regulation 
(Databeskyttelsesforordningen) and Databeskyttelsesloven.  Accordingly, the parents must be 
informed separately about this in the mandatory GDPR information sheet and a valid consent 
must be obtained.     
6.11 Statistical methods  
Reporting of the trial will be done in accordance with the CONSORT guidelines for cluster 
randomized trials. 
6.11.1 Primary analyses 
The analyses of the predefined primary outcomes will be planned a priori and made publicly 
available in a statistical analysis plan at clinicaltrials.org. The primary analysis will be 
conducted on an intention-to-treat basis using mixed regression analysis with school as 
random effect using degrees-of-freedom correction (Satterthwaite) to control for type 1 error 
due to the moderate number of clusters. Because the school is the unit of randomization (not 
municipality, region, or school-class) and the intervention is being applied at this level, no 
further cluster-level will need to be considered statistically. Analyses will be adjusted for 
baseline factors that are found to be related to individual schools (clusters) to control for 
possible baseline imbalance of cluster- and participant level data. In analyses using more than 
two assessment points, random slope effects of time will be considered to examine the 
possible heterogeneity of effects according follow-up time. In all intention-to-treat analyses, 
data from all participating children at inclusion will be included. All hypotheses testing will be 
based on two-sided tests at the alpha=0.05 level. 
In addition, several sub-group analyses will be predefined and outlined in the final statistical 
analysis plan before the start of the trial. This will include subgroup analyses by e.g., parent 
socio-economic status, school district characteristics, and baseline adiposity status (being 
normal weight at baseline vs. being overweight or obese at baseline). Sub-group analyses 
among normal weight children at baseline will also be used to examine the effectiveness of 
the program on incidence of overweight or obesity. Other outcomes or sub-group analyses 
that are not predefined in the final study statistical analyses plan published before the start 

 
 
 
 
 
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of the trial, will be defined explicitly as exploratory post hoc analyses in the papers and the 
exploratory nature of these analyses will be mentioned as a major limitation. Per-protocol and 
complete case analyses of the primary and secondary outcomes will also be carried out. We 
will analyze the association between implementation fidelity and actual dose delivered of 
each intervention activity in each intervention setting and its association with intervention 
outcomes among children. 
In the final statistical analysis plan, a detailed plan to adjust for multiplicity based on a priority 
of the secondary outcomes and follow-up time points will be outlined. 
6.11.2 Secondary analyses 
Analysis and reporting of predefined secondary outcomes will be mentioned explicitly as 
secondary outcome analyses in the papers.  
6.11.3 Exploratory analyses 
All analyses that were not pre-planned will be labelled as exploratory analyses.  
6.11.4 Safety analysis 
A safety analysis will be carried out to summarize any reported adverse events associated with 
participation in the study. 
6.11.5 Definition of datasets 
Quantitative datasets will be generated from the REDCap databases for each specific research 
aim guided by a predefined analysis plan. When registry data are needed for analyses, and 
these cannot be stored locally in REDCap, data stored in REDCap will be uploaded to 
‘Forskermaskinen’ at Statistics Denmark. 
6.11.6 Handling of missing values 
Missing values will be handled via the mixed regression modelling approach to analyses 
(110,111).  If alternative analyses are carried out missing values will be imputed using multiple 
imputation or inverse-probability weighting.   
6.12 Suspension or early termination of the study  
The principal investigator may suspend or prematurely terminate parts of or the entire clinical 
study for significant and documented reasons. If a suspicion relating to an unacceptable risk 

 
 
 
 
 
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to study participants arises during the study, the principal investigator will suspend the study 
while the risk is assessed. The principal investigator will terminate the study if an unacceptable 
risk is confirmed. The principal investigator must ensure that the premature termination is 
justified in writing (fill out the termination form) and that the parents of the participants are 
informed. 
6.13 Serious adverse events and reporting 
6.13.1 Serious adverse events 
A serious adverse event is defined as any untoward medical occurrence in a study participant 
that: 
• Results in death 
• Is life-threatening at the time of the event 
• Requires inpatient hospitalization 
• Results in persistent or significant disability or incapacity. 
6.13.2 Reporting of Serious adverse events 
The principal investigator will immediately inform the ethics committees if a serious adverse 
event occurs during the project. Reporting will take place no later than 7 days after the 
principal investigator became aware of any such adverse event. The standard forms from the 
ethics committees will be used for this purpose. In case of serious adverse events resulting 
from the project, the investigator will make any information requested by the committee 
available.  
When the study ends, the principal investigator will provide a list of all serious expected and 
unexpected adverse reactions and all serious adverse events that have occurred during the 
study period. The report will be accompanied by an assessment of the participants' safety. The 
report will be delivered using the forms prepared by the committee system. 

 
 
 
 
 
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6.14 Study Documentation 
6.14.1 Publication of Results 
Results from the study, whether positive, negative, or inconclusive, will be summarized and 
published in peer-reviewed scientific journals and/or as part of scientific conferences. 
Authorship of publications should in agreement with the publication approval procedure 
reflect the collaborative nature of the project. 
The project is registered in www.clinicaltrials.gov 
7 Ethical conduct of the study 
The study will be conducted in accordance with the ethical principles set forth in the current 
version of the Declaration of Helsinki. Children in the participation classes that are not enrolled 
in the study will be invited to participate in all activities that are like what could happen during 
the school day anyway, but without any examinations and data registration. 
It always, and especially for families with small and younger children, interferes with everyday 
life to participate in a clinical study as it requires time to be set aside to comply with the 
procedures of the study, and some procedures may be associated with a risk. 
7.1 Ethical approval and study registration 
Ethical approval is obtained by the Scientific Ethics Committee in the Region of Southern 
Denmark (Project ID S-20220094) and the data processing of the participants’ personal data 
and biological material and the study is registered on statutory lists before enrolment of any 
study participants. 
7.2 Justification of the study 
Investigation of the effectiveness of a health promotion intervention program in children on 
health outcomes is not possible to conduct with high validity in a non-randomized experiment 
or in an observational study. Thus, for the present study there is a need for a control group 
and to investigate the aims of the study using an experimental randomized study design. The 
study will provide important new knowledge about the effectiveness of the Generation 

 
 
 
 
 
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Healthy Kids program, a novel multicomponent intervention developed using a systems 
approach that can benefit children in Denmark and elsewhere in the future.  
7.3 Underage study participants - justification and precautions 
Justification of inclusion of children in the clinical study is in line with the Committee act 
(Komitéloven §19, stk. 3) which concerns studies not involving medicine, as the project can 
only be conducted in the described age group to answer the objective stated in section 5. 
Further, it is justified to recruit children of this young age as the overall project and main trial 
is focused on early prevention of overweight at school start before the overweight prevalence 
starts to rise markedly. Also, as described below, the study gives minimal risk of harm for the 
participants, and it is our assessment that the benefits outweigh the potential harms. 
7.4 Children of ethnic minority 
All children in the participating classes are eligible for the study. Written information materials 
will be translated depending on what is needed in the local school district. Verbal information 
will as standard be in Danish, but interpreters will be present at meetings if needed.  
7.5 Risks and safety in relation to conducting the study 
The interventions will not include focus on weight, but instead promote well-being, healthy 
habits, sense of community, and play. All communication will be prepared carefully in terms 
of non-stigmatization of children or families and there will not be any focus on weight related 
issues. 
Participation in the study is associated with minimal risks.  We have thoroughly considered 
the ethical aspects of the discomfort of the biological sampling (only children in DK-East). Since 
the blood samples are crucial for investigating the outcomes of the study (including diet and 
health related biomarkers), the discomfort of the blood sample is considered to be 
outweighed by its usefulness. The discomfort of blood sampling will be minimized by use of 
local anaesthetic patches before blood sampling and blood will be sampled by skilled 
laboratory technicians or other trained and qualified staff. The only expected risk of the 
biological sampling is a mild pain at the site of the blood sampling on the arm and potentially 
a small blue bruise at the site of the prick, which will disappear within a few days. Risks for 
infections that are associated with blood sampling are extremely low.  

 
 
 
 
 
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The children in DK-East will be asked to meet for the visits after an overnight fast to 
standardize the blood results. They have time to eat immediately after the blood sample, at 
10:30 am the latest, and, as in our previous trials with blood sampling in children they are 
allowed to drink 100-200 ml during the fasting period and up to 1-2 hours before the blood 
sampling. A fasting period of this duration is relatively short, and we do not expect the children 
to experience considerable discomfort due to the fasting. However, if this should be the case, 
the examinations will be discontinued immediately, and the child will be offered drinks and 
food. 
The BOD POD body composition measurement is crucial for investigating the primary outcome 
of the main trial (fat mass). The measurement uses air-displacement plethysmography, is safe 
and approved for children, and takes few minutes. The measurement is constantly monitored 
by the operator and if the child expresses discomfort sitting inside the BOD POD, the 
measurement will be stopped immediately. Bioimpedance measurements are also non-
invasive and not associated with risk or harm. 
 
There is a risk of more focus on weight related issues e.g., overweight when measuring height, 
weight, and waist circumference. Therefore, the personnel will be trained to talk carefully 
about the measurement and to handle comments on body weight related issues from peers. 
Moreover, the children will not be told the measurement numbers (numbers on digital scale 
is hidden) and they can wear light clothing during the examinations. 
There are no considerable risks related to the school meals which are prepared using foods 
that are part of a normal diet. The parents will be asked about food allergies at project start-
up and will be informed to check the menu plans with ingredients allergens online the week 
before. The children will be instructed in hygiene e.g., hand washing. The risk of injury or 
discomfort of performing the muscular and fitness tests are comparable to the risk children 
are exposed to during daily life and play. In case of any discomfort or accident the activity will 
be discontinued. 
The risk or side effect of participating in the measurement of physical activity based on our 
extensive experience in carrying out physical activity measurement in paediatric populations 
is minimal. However, attaching the monitor to the skin on the thigh, might be unpleasant for 
some children and might in some rare cases result in skin irritation or an allergic reaction to 
the adhesive tape. The parents and the child will receive written and oral instruction about 
the instruments, and how the instrument can be removed gently. Furthermore, the written 
information will contain information on which symptoms to be aware of to reduce any 
physical inconveniences in case of an allergic reaction, and whom to contact in case of an 

 
 
 
 
 
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allergic reaction. If the children participating in this project are allergic to adhesive tape, have 
eczema or other skin problems (see appendix 2A and 2B), they will be offered to wear a 
monitor in a thigh belt. The belts include skin friendly silicone to keep the belt in place during 
the child´s play. Children/parents can switch the belt between the right and left leg if 
necessary and to avoid/reduce potential skin irritation. 
7.6 Benefits of the study and risk-benefit evaluation 
The overall aim of Generation Healthy Kids is to promote healthy weight and wellbeing in 
children and is expected to benefit future generations of children. Furthermore, it is expected 
that the study will generate new and important knowledge on how to promote sustainable 
changes and potentially how to scale-up.  
The participation in a study can cause some inconvenience to daily life and can be time-
consuming. During the study, the families in the intervention schools will receive free school 
meals for the children, inspiration, and support for healthier lifestyle habits, and at the control 
schools the participating classes will be invited to an activity day by the end of the study period 
and teachers will be offered education in FIT FIRST teen. All participating children will receive 
a small gift at each measurement round (see section 9), and after completion of the study all 
children will receive a diploma (Appendix 22). After data analysis, and publication of the main 
scientific papers, the parents can read about the study's main conclusions on the project's 
website. In addition, the parents of children that have provided a blood sample will receive 
the child’s iron status. The schools and local communities are also expected to benefit from 
the study in terms of elevated knowledge and focus on a healthy lifestyle. 
All things considered, the study is judged to be ethically justified and proper as the individual, 
scientific and societal benefits are believed to outweigh the limited discomfort and very low 
risk of harm associated with the study. 
7.7 Participant Information and Informed Consent 
Written, informed consent will be obtained from all parents/legal guardians to the subjects 
prior to entry into the study and execution of any study-related procedures. PI or delegated 
and qualified project staff will explain verbally to parents/legal guardians the objectives, 
nature, significance, risks, and implications of the study before inclusion. This information will 
also be included in the written subject information sheet. The information will be given at 
meetings at each school. If the parents/legal guardians are not able to join the meeting, they 
can arrange a separate meeting with project staff.  

 
 
 
 
 
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The parents/legal guardians will be offered to bring with them an assessor to the information 
meeting and after the meeting they are given time to discuss any questions and decide on 
participation in the study. All parents/legal guardians will receive a copy of the subject 
information sheet. The children will be informed of the objectives and procedures of tests in 
a language they can understand. The procedures are explained in more detail in section 6.2.5 
and in the participant information. 
7.8 Protocol Changes 
Substantial amendments to this protocol may be implemented only after a favourable opinion 
of the Ethics Committees has been obtained. Amendments to the protocol are regarded as 
substantial if they have a significant impact on: 
• The safety, physical health, and mental integrity of the study subjects 
• The scientific value of the study 
• The conduct or the management of the study 
7.9 Protocol Deviations 
No systematic deviations from the protocol are allowed. All significant protocol deviations 
noted during the study (by the Investigator) will be recorded in the e-CRF (REDCap).  
7.9 Insurance 
The participants are insured in accordance with the Law: “Lov om arbejdsskadeforsikring” (cf.  
LBK nr 1186 af 19/08/2022) by the current insurance at University of Southern Denmark and 
University of Copenhagen. During the study the participants will be covered by law: “Lov om 
klage- og erstatningsadgang inden for sundhedsvæsenet” (cf. LBK no. 995 14/06/2018 
www.retsinformation.dk). 
8 Funding 
The initial concept of the Generation Healthy Kids was developed by the Investigators of the 
study. Generation Healthy Kids is funded by the Novo Nordisk Foundation with 80 mio. DKK in 
total, covering both the pilot study and the main trial.  The study funds have been transferred 
to a research account at University of Copenhagen, which is subject to public audit. The 
funding will primarily cover salary for project staff (PhD students, postdocs, medical laboratory 

 
 
 
 
 
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technicians, project managers and communication staff) and expenses related to operation 
e.g., school food, buy out of teachers, measurement equipment, analysis of blood samples, 
car rent, and communication materials. Funding will not be used for paying subjects.  
The Investigators declare to have no financial interests in the results of the study or any 
economic affiliation with any of the project partners. 
9 Remuneration for study participants 
There will be no remuneration for the study participants. In addition to the free school meals, 
which will be offered to all children in the intervention school classes, all participating children 
will receive a small gift (e.g. a sticker, LEGO figure or key ring) at a value of up to 30 DKK at 
each measurement round. Also, due to the inconvenience of the blood samples and the 
preceding overnight fasting, children whose parents have consented to blood sampling in DK-
East, will receive a small gift (e.g. a small LEGO package) at a value of 70-130 DKK at each 
round of blood sampling. Parts of the gifts have been donated by LEGO Charity and the gifts 
are similar to those provided in Danish hospitals, when children have blood samples taken. 
Considering this, and the small size of the gifts, it is our assessment that it will not affect the 
willingness to consent and is therefore ethically appropriate. 
 
 

 
 
 
 
 
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11 List of Appendices (all in Danish) 
Appendix 1: Protokol resumé   
Appendix 2A: Spørgeskema om fødevareallergi, allergi over for plaster, kronisk sygdom og 
andre hensyn 
Appendix 2B: Spørgeskema om allergi over for plaster, kronisk sygdom og andre hensyn 
(kontrolskoler) 
Appendix 3: Drop-out skema  
Appendix 4A og 4B: Invitationsbrev til interventionsskoler og kontrolskoler 
Appendix 4Aa og 4Ba: Invitationsbrev til nye elever på interventionsskoler og kontrolskoler 
Appendix 5A og 5B: Deltagerinformation til interventionsskoler og kontrolskoler 
Appendix 6A og 6B: Samtykkeerklæring (Komitéens Standardblanketter S5 og S6) 
Appendix 7: Forældrefuldmagt  
Appendix 8A og 8B: Pjece om informationsmøde til interventionsskoler og kontrolskoler 
Appendix 9: Plakat om informationsmøde 
Appendix 10: Spørgeskema om familiebaggrund, idræt og solvaner 
Appendix 11: Spørgeskema om pubertetsudvikling til forældre med drenge 
Appendix 12: Spørgeskema om pubertetsudvikling til forældre med piger 
Appendix 13: Spørgeskema om barnets kost 
Appendix 14: Spørgeskemaet KIDSCREEN 27  
Appendix 15: SCREENS modificeret spørgeskema  
Appendix 16: Børns søvnvaner spørgeskemaet  
Appendix 17: Uønskede hændelser og samtidig medicin 

 
 
 
 
 
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Appendix 18: Spørgeskema om dækning af basale psykologiske behov og IM under 
interventionsaktiviteter 
Appendix 19: Spørgeskema til børn om physical literacy 
Appendix 20: Spørgeskema til børn om deltagelse i fritidsidræt 
Appendix 21: Spørgeskema om madkompetence og måltidskultur 
Appendix 22: Diplom 
Appendix 23: Procesevalueringsspørgeskema for børn 
Appendix 24: Smileyskala til børneevaluering af interventionskomponenter 
Appendix 25: Spørgeskema til forældre om deres indkøbsvaner 
Appendix 26:  Forældrerapporteret trivsel 
Appendix 27A, B, C, D: Videoer om BODPOD, bevægelsesmåler, blodtryk og blodprøve 
Appendix 28a: Husk at plakat og flyer_indsatsskoler  
Appendix 28b: Husk at plakat og flyer_kontrolskoler  
Appendix 29a: Oversigtsbrev og orientering om lodtrækning_indsatsskoler  
Appendix 29b: Oversigtsbrev og orientering om lodtrækning_kontrolskoler  
Appendix 30a: Personlig sms indsatsskoler  
Appendix 30b: Personlig sms kontrolskoler