Child HealthChild-COOPNCT06185413
Children's Cooperation Denmark: a 3-year System Dynamics Trial
A study testing Participatory system dynamics approach in people with Child Health and Child Behavior, run by Aarhus University Hospital at 5 sites in Denmark.
Trial summary
Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Health, Child Behavior, Physical Inactivity
- What is being tested?
- Participatory system dynamics approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 5 sitesDenmark
- Study dates
- 13 Sep 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children from grade 1 (aged 6-7 years) to grade 6 (aged 11-12 years) at the participating schools
Who cannot join
- No
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Halsnæs Municipality
Hundested
Vordingborg municipality
Lundby
Randers Municipality
Randers
Syddjurs municipality
Skørring, 8530
Odsherred Municipality
Vig
About this study
Official title: Children's Cooperation Denmark (Child-COOP): Promoting Healthy Physical Activity Behaviour in Children Aged 6-12 Years: a 3-year System Dynamics Trial
Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. The three-year Child-COOP trial aims to explore if a participatory system dynamics approach can promote (increase and sustain) healthy PA behaviour in schoolchildren aged 6-12 years through changes at the local system level. The five Danish municipalities will each participate with an intervention community and a comparison community. First, local health profiles of children will be collected and used to engage key leaders and stakeholders from intervention communities and municipal administrations in participatory processes. These will be used to develop a systems map of drivers of PA behaviour in schoolchildren aged 6-12 years in the local communities. Second, based on the systems map, stakeholders from the civic and private sectors will be involved in developing and implementing actions to promote healthy PA behaviour through system changes. The trial will be evaluated in a pre-post design to compare intervention effects between the communities and identify outcomes at individual level and systems level. A process evaluation will be made to map the activities in a final systems program theory on "what works for whom under what circumstances". Results will be used in future recommendations and to assess the potential for upscaling to national level. Child-COOP will be based on a collaboration between the five Danish municipalities, the Steno Diabetes Centres in Aarhus, Copenhagen and Zealand, Aarhus University and Deakin University, Australia. Centre for Health Promotion in Practice, Local Government Denmark (KL) and the Danish Healthy Cities Network (Sund By Netværket) will contribute with feedback on project progress and dissemination of project results.
Read the detailed description
The Child-COOP trial was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. Two feasibility studies were initiated in 2021 and still running - and Child-COOP was subsequently adapted and adjusted.
INTRODUCTION Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness and promotion of healthy PA behaviour is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. Social inequity in health is also mirrored in PA behaviour among children. Children in families with few resources are known to be less physically active compared to peers in more affluent families. One way to promote healthy PA behaviour in children, which also considers inequity challenges, is to develop more health-enhancing active leisure communities. Unfortunately, dropout from active leisure communities is common in the transition from childhood to adolescence. These high dropout rates call for identification of initiatives that encourage children to engage in active leisure communities throughout childhood and youth. However, both sedentary behaviour and moderate-to-vigorous PA have been found to be independent predictors for health status, and they are not mutually related. Hence, focussing solely on reaching the recommended levels of daily PA is not sufficient. Instead, a comprehensive strategy is warranted to ensure that more time is spent on light, moderate and vigorous PA and less time on sedentary activity. Promoting (initiating and sustaining) a healthy PA behaviour is not an easy task because PA behaviour is shaped by a complex interplay between a wide range of factors at individual, family, community and society levels. Interventions building on a participatory system dynamics approach has been suggested as a feasible way to address such complex problems as they combine the current evidence base on prevention, best practice and local wisdom to achieve new knowledge and create solutions. A participatory system dynamics approach implies that a variety of engagement and solutions at different system levels may occur at both the interpersonal and organisational levels. This strategy has already proven successful in several international childhood obesity prevention interventions. The participatory system dynamics approach remains to be tested in a large-scale Danish context. During the past year, our research group has tested the participatory system dynamics approach in different settings in Denmark. We propose to conduct a participatory system dynamics trial across ten communities in five municipalities to create local solutions to promote healthy PA behaviour in Danish schoolchildren through Child-COOP.
AIM
The overall aim is to evaluate a participatory system dynamics approach to promote (increase and sustain) healthy PA behaviour in 6- to 12-year-old schoolchildren in local communities in Denmark through the following sub-aims:
- Measuring the effectiveness on the children's PA behaviour by assessing changes in time spent sedentary and time spent at light, moderate and vigorous intensity at three-year follow-up
- Estimating changes at system level such as assessing changes in community systems, community networks structure, policy and practice at three-year follow-up
- Identifying health-economic implications by assessing both a cost consequence analysis and an explorative analysis of the derived effects at three-year follow-up
- Conducting a process evaluation to map a final systems program theory on "what works for whom under what circumstances" to be used as a framework in future recommendations and up-scaling.
TRIAL COMPONENTS
The Child-COOP trial consists of three stages:
Stage 1: Preparation: selection of communities, training and monitoring (12 months) Selection of communities: The communities will be selected and defined by the municipalities based on their local challenges related to children's PA behaviour, socially deprived areas and motivation.
Training: Employees from all participating municipalities will receive training in how to run local community initiatives based on a participatory system dynamics approach. The target group for the training is Child-COOP municipal coordinators and other employees in the municipality taking part in the project. The training will consist of seminars and homework. The purpose of the training is to build capacity for municipal employees to understand and act within the framework of the participatory system dynamics approach and to solve complex health challenges regarding children's PA behaviour.
Monitoring: A local childhood health profile will be generated to outline daily PA behaviour, sleep patterns and leisure time activities at baseline (based on survey and objective data) and factors associated with PA behaviour in children, e.g. mental health, screen use and parental support. This profile will be generated at baseline based on survey and objective data (see details in "Individual level: data collection and measurements").
Stage 2: Recruitment, group model building (GMB) and systems mapping (9 months) Recruitment of key leaders and local stakeholders: A coordinator from each municipality will together with the research team identify and recruit key leaders (e.g. local politicians, department heads, municipality leaders) and local stakeholders (e.g. school board members, school principal, school nurse, sport club representatives). Key leaders and local stakeholders will be selected based on authority and capacity to initiate actions that are likely to influence the children's PA behaviour across sectors and organisations. During this stage, key leaders must commit to allocate resources to ensure subsequent implementation. The aim is to recruit 12-15 key leaders and local stakeholders from each community.
GMB process and systems mapping: During this stage, three workshops (WS1, WS2 and WS3) will be held at each participating community. WS1 and WS2 will engage the key leaders and stakeholders, and local childhood health data will be presented to provide the first critical engagement step. In these two workshops, the key leaders and stakeholders will map the system by building a causal loop diagram (CLD) to understand how the perceived local system affects the children's daily PA behaviour in their community. In WS3, all community members willing to engage in changing the local system will be invited to identify priority areas for action based on the developed CLD from WS1 and WS2.
Stage 3: Implementation of actions, support and monitoring (24-30 months) Actions and support: The output of WS3 is the formation of local working groups that will focus on implementing the chosen actions. The working groups will be supported and supervised by a backbone office consisting of the Child-COOP municipality coordinator(s) and the research team. A follow-up workshop (WS4) will be held with the key stakeholders six months after completion of WS3 to review the consolidated priority actions. To increase and maintain motivation and actions in the local community, subsequent follow-up meetings will be held with the working groups when needed during the 24-30 months after WS3.
Monitoring: Survey childhood health data will be collected from the study population on an annual basis and from the newly enrolled schoolchildren (first grade) every year (see details in "Individual level: data collection and measurements"). At an annual meeting in each community, these data on the children's health and well-being in the local community will be presented to actions groups, key leaders and stakeholders to sustain and promote engagement.
RESEARCH PLAN
Child-COOP will be evaluated through an assessment of outcomes at individual and systems level, process and economic implications. Combined, these three elements will give an essential understanding of what it would require to upscale Child-COOP to regional or national level. Few guidelines exist on how to evaluate public health programs in complex adaptive systems. Child-COOP is inspired by both the Medical Research Council recent evaluation guidelines for process evaluations of complex interventions and the newly developed ENCOMPASS framework aiming to generate a comprehensive, yet practically realistic evaluation. The evaluation will be structured along the realist research cycle, and a critical first step is to develop an initial program theory to inform how the participatory system dynamics intervention is expected to produce change. Given the participatory approach in Child-COOP, the exact outcomes and actions are unknown in advance. Consequently, the evaluation will be constructed to allow for systematic documentation of processes and outcomes. A final systems program theory on "what works for whom under what circumstances" based on the participatory systems dynamic approach will be made, including recommendations for large-scale implementation across different settings.
System level: data collection and measurements
Engagement and commitment will be measured by a survey to document changes at community and organizational level. The survey will be distributed to all participants attending workshops and will enrol new workings groups' members continuously at base line (defined as first attendance) after one year and at two-year follow-up.
Participatory mapping of communities will be assessed through online workshops with the participants attending the workshops. The online workshops will supplemented by survey data provide evaluation and formative insight into the local network of each community.
Actions implemented will be evaluated by using Ripple Effects Mapping method which asses the number of actions and where they have been initiated in the system. Action Scales Model is used to asses leverage point of each action implemented. Both methods will be used in workshops with working groups every 6 months for a two-year period.
Change in local systems will be understood through Causal loop diagrams (CLDs) built during the GMB workshops, which will be enriched with observation data from the workshops and survey data to quantify actions, collaborations and system changes over time and to assess the impact of actions and networks on variables in the system. To support the GMB method, the software program "Systems Thinking in Community Knowledge Exchange" (STICKE) will be used together with internationally developed, tested and standardised scripts.
Process evaluation: data collection and measurements
Quantitative data for the process evaluation will be collected with the same procedures as described at system level (to assess reach). Moreover, we will also use the results of "ripple effect mapping" (REM) to understand the solutions and actions developed in the local communities. Additional data will be collected through interviews, focus groups, structured observations and follow-up interviews before, during and after the GMB workshops to access the overall process. The process evaluation will also include structured observations/checklists collected during workshops (to assess dose). Interviews or focus group discussions with workshop participants and participants dropping out of the GMB processes will be used to assess participant responsiveness. These data will be used to understand the mechanisms in Child-COOP. Furthermore, adherence to the participatory system dynamics approach will be assessed by routinely (every 6 months) collected information regarding implementation, engagement and actions of key leaders and stakeholders, political will and advocacy. In addition adherence, dose, quality of delivery, participant responsiveness and reach will be assessed to gain knowledge on how the participatory system dynamics approach was delivered and implemented and to inform a final program theory.
- Conditions
- Child Health, Child Behavior, Physical Inactivity, Child Obesity
- Being tested
- Participatory system dynamics approach
- Keywords
- Participatory system dynamics approach, Group Model Building, Children
- Medical subject headings
- Child Behavior, Sedentary Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory system dynamics approachOther
Also called Group Model Building
First, local health profiles of children will be collected and used to engage key leaders and stakeholders from intervention communities and municipal administrations in participatory processes. These will be used to develop a systems map of drivers of PA behaviour in schoolchildren aged 6-12 years in the local communities. Second, based on the systems map, stakeholders from the civic and private sectors will be involved in developing and implementing actions to promote healthy PA behaviour through system changes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention communities | Experimental | A participatory system dynamics approach will be implemented by the municipal staff and research group. Receives: Other: Participatory system dynamics approach |
| Comparison communities | No intervention | No intervention will be applied, but according to the wait-list design, the participatory system dynamics approach will be implemented in the comparison community by the municipal staff after follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group change in total movement time (children)
Total daily time the children spent moving in different body positions and engaging in different physical activities (standing, walking, running and biking). To asses changes in total movement, movement behaviour will be measured with thigh worn accelerometers (Axivity AX3) for 8 consecutive days.
Measured: Measured at baseline and at 3 year follow-up.
Between group change in time spent being sedentary (children)
Sedentary time is defined as any waking activity characterized as being in a sitting, reclining or lying posture with minimal stationary movement. Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3).
Measured: Measured at baseline and at 3 year follow-up.
Between group change in time being moderate to vigorous physical active (MVPA) (children)
Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3) (www.hbsc.dk/download/HBSC-Fysisk-aktivitet-monitorering-2022.pdf page 17).
Measured: Measured at baseline and at 3 year follow-up.
Secondary outcomes (16)
Between group change in total evening and night reclining as a measure of sleep duration (children)
Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3) and survey data
Measured: Measured at baseline and at 3 year follow-up.
Change in proportion meeting the sleep guidelines (children)
Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3) and survey data.
Measured: Measured at baseline and at 3 year follow-up.
Fitness level (children)
Fitness level will be measured using Andersens running test (Aadland E, Terum T, Mamen A, Andersen LB, Resaland GK. The Andersen aerobic fitness test: reliability and validity in 10-year-old children. PLoS One. 2014 Oct 17;9(10):e110492. doi: 10.1371/journal.pone.0110492. PMID: 25330388; PMCID: PMC4201545)
Measured: Measured at baseline and at 3 year follow-up.
Strength level (children)
Strength will be measured using a hand-grip dynamometer
Measured: Measured at baseline and at 3 year follow-up.
Leg power (children)
Leg power will be measured using standing long jump test
Measured: Measured at baseline and at 3 year follow-up.
Coordination (children)
Number of side-jumps in 30 seconds
Measured: Measured at baseline and at 3 year follow-up.
Physical literacy (children)
Assessed through a questionnaire. A Danish developed questionnaire developed from the Cana-dian Assessment of Physical Literacy (Elsborg P, Melby PS, Kurtzhals M, Tremblay MS, Nielsen G, Bentsen P. Translation and validation of the Canadian assessment of physical literacy-2 in a Danish sample. B M C Public Health. 2021;21. 2236. doi.org/10.1186/s12889-021-12301-7)
Measured: Measured at baseline and at 3 year follow-up.
Change in BMI z-scores (children)
Data is collected via a portable stadiometer and bioimpedance digital scale (InBody270).
Measured: Measured at baseline and at 3 year follow-up.
Change in weight status in %
Between group difference in change in prevalence of children with underweight, normalweight, overweight and obesity, based on the cutoffs defined by Cole et al. and the International Task Force of Obesity. Body weight is measured by a bioimpedance analysis (InBody 270) and height by using a portable stadiometer.
Measured: Measured at baseline and at 3 year follow-up.
Change in the overweight and obesity prevalence calculated using the WHO cut points (children)
Data is collected via a stadiometer and bioimpedance digital scale (InBody270).
Measured: Measured at baseline and at 3 year follow-up.
Health-related quality of life (children)
Between group difference in change in the total summary score of health-related quality of life measured with the KIDSCREEN 27 child self-report questionnaire. Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer. The questionnaire assesses the child's physical well-being (5 items), psychological well-being (7 items), autonomy and parent relation (7 items), peers and social support (4 items), and school environment (4 items).
Measured: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of fruit consumed weekly (children)
A simple dietary questionnaire: 'How often do you eat fruit?' with the following categories: 'Every day', '5-6 days per week'. '3-4 days per week', '1-2 days per week', 'Never or almost never'
Measured: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of non-core (discretionary) foods consumed weekly (children)
A simple dietary questionnaire: 'How often do you eat candy, chips or cake?' with the following categories: 'Every day', '5-6 days per week'. '3-4 days per week', '1-2 days per week', 'Never or almost never'
Measured: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of sugar-sweetened beverages consumed weekly (children)
A simple dietary questionnaire: 'How often do you drink sugar-sweetened beverages (eg. soda, juice and cocoa)?' with the following categories: 'Every day', '5-6 days per week'. '3-4 days per week', '1-2 days per week', 'Never or almost never'
Measured: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of vegetable weekly (children)
A simple dietary questionnaire: 'How often do you eat vegetables?' with the following categories: 'Every day', '5-6 days per week'. '3-4 days per week', '1-2 days per week', 'Never or almost never'
Measured: Measured at baseline and at 3 year follow-up.
Height
Between group difference in change in standing height measured using a portable stadiometer.
Measured: Measured at baseline and at 3 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start13 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Study design: A wait-list design will be applied to assess three-year effectiveness of the participatory system dynamics approach to promote (increase and sustain) healthy physical activity behaviour among approximately 3000 children aged 6- to 12 years. Five municipalities have agreed to participate: two in the Central Denmark Region, one in the Capital Region of Denmark and two in the Zealand Region. Each municipality will allocate two communities to be either intervention or comparison community. According to the wait-list design, the participatory system dynamics approach will be implemented in the comparison community by the municipal staff after follow-up.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Deakin University
- Responsible party
- Principal investigator, Jane Nautrup Østergaard, Aarhus University Hospital
- Investigators
- Jane Nautrup N Østergaard, PhD, Principal investigator, Steno Diabetes Center Aarhus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185413
- Sponsor's protocol ID
- 790941
- Acronym
- Child-COOP
- Status last verified
- Jan 2025
- First submitted
- 11 Sep 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melby PS, Elsborg P, Nielsen G, Lima RA, Bentsen P, Andersen LB. Exploring the importance of diversified physical activities in early childhood for later motor competence and physical activity level: a seven-year longitudinal study. BMC Public Health. 2021 Aug 2;21(1):1492. doi: 10.1186/s12889-021-11343-1.
PubMed 34340663Kristensen PL, Moller NC, Korsholm L, Wedderkopp N, Andersen LB, Froberg K. Tracking of objectively measured physical activity from childhood to adolescence: the European youth heart study. Scand J Med Sci Sports. 2008 Apr;18(2):171-8. doi: 10.1111/j.1600-0838.2006.00622.x. Epub 2007 Jun 6.
PubMed 17555542Ryan DJ, Stebbings GK, Onambele GL. The emergence of sedentary behaviour physiology and its effects on the cardiometabolic profile in young and older adults. Age (Dordr). 2015 Oct;37(5):89. doi: 10.1007/s11357-015-9832-7. Epub 2015 Aug 28.
PubMed 26315694Rutter H, Cavill N, Bauman A, Bull F. Systems approaches to global and national physical activity plans. Bull World Health Organ. 2019 Feb 1;97(2):162-165. doi: 10.2471/BLT.18.220533. Epub 2018 Dec 19. No abstract available.
PubMed 30728623Hovmand P. Community based systems dynamics. 1. ed. New York: Springer-Verlag; 2014
Allender S, Brown AD, Bolton KA, Fraser P, Lowe J, Hovmand P. Translating systems thinking into practice for community action on childhood obesity. Obes Rev. 2019 Nov;20 Suppl 2(Suppl 2):179-184. doi: 10.1111/obr.12865. Epub 2019 Jul 29.
PubMed 31359617Luna Pinzon A, Stronks K, Dijkstra C, Renders C, Altenburg T, den Hertog K, Kremers SPJ, Chinapaw MJM, Verhoeff AP, Waterlander W. The ENCOMPASS framework: a practical guide for the evaluation of public health programmes in complex adaptive systems. Int J Behav Nutr Phys Act. 2022 Mar 28;19(1):33. doi: 10.1186/s12966-022-01267-3.
PubMed 35346233Nobles J, Wheeler J, Dunleavy-Harris K, Holmes R, Inman-Ward A, Potts A, Hall J, Redwood S, Jago R, Foster C. Ripple effects mapping: capturing the wider impacts of systems change efforts in public health. BMC Med Res Methodol. 2022 Mar 18;22(1):72. doi: 10.1186/s12874-022-01570-4.
PubMed 35300619
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Cooperation Denmark (Child-COOP): Promoting Healthy Physical Activity Behaviour in Children Aged 6-12 Years: a 3-year System Dynamics Trial
- ClinicalTrials.gov ID
- NCT06185413
- Acronym / sponsor ID
- Child-COOP / 790941
- Conditions
- Child Health, Child Behavior, Physical Inactivity, Child Obesity
- Keywords
- Participatory system dynamics approach, Group Model Building, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Deakin University
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. The three-year Child-COOP trial aims to explore if a participatory system dynamics approach can promote (increase and sustain) healthy PA behaviour in schoolchildren aged 6-12 years through changes at the local system level. The five Danish municipalities will each participate with an intervention community and a comparison community. First, local health profiles of children will be collected and used to engage key leaders and stakeholders from intervention communities and municipal administrations in participatory processes. These will be used to develop a systems map of drivers of PA behaviour in schoolchildren aged 6-12 years in the local communities. Second, based on the systems map, stakeholders from the civic and private sectors will be involved in developing and implementing actions to promote healthy PA behaviour through system changes. The trial will be evaluated in a pre-post design to compare intervention effects between the communities and identify outcomes at individual level and systems level. A process evaluation will be made to map the activities in a final systems program theory on "what works for whom under what circumstances". Results will be used in future recommendations and to assess the potential for upscaling to national level. Child-COOP will be based on a collaboration between the five Danish municipalities, the Steno Diabetes Centres in Aarhus, Copenhagen and Zealand, Aarhus University and Deakin University, Australia. Centre for Health Promotion in Practice, Local Government Denmark (KL) and the Danish Healthy Cities Network (Sund By Netværket) will contribute with feedback on project progress and dissemination of project results.
Detailed description
The Child-COOP trial was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. Two feasibility studies were initiated in 2021 and still running - and Child-COOP was subsequently adapted and adjusted.
INTRODUCTION Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness and promotion of healthy PA behaviour is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. Social inequity in health is also mirrored in PA behaviour among children. Children in families with few resources are known to be less physically active compared to peers in more affluent families. One way to promote healthy PA behaviour in children, which also considers inequity challenges, is to develop more health-enhancing active leisure communities. Unfortunately, dropout from active leisure communities is common in the transition from childhood to adolescence. These high dropout rates call for identification of initiatives that encourage children to engage in active leisure communities throughout childhood and youth. However, both sedentary behaviour and moderate-to-vigorous PA have been found to be independent predictors for health status, and they are not mutually related. Hence, focussing solely on reaching the recommended levels of daily PA is not sufficient. Instead, a comprehensive strategy is warranted to ensure that more time is spent on light, moderate and vigorous PA and less time on sedentary activity. Promoting (initiating and sustaining) a healthy PA behaviour is not an easy task because PA behaviour is shaped by a complex interplay between a wide range of factors at individual, family, community and society levels. Interventions building on a participatory system dynamics approach has been suggested as a feasible way to address such complex problems as they combine the current evidence base on prevention, best practice and local wisdom to achieve new knowledge and create solutions. A participatory system dynamics approach implies that a variety of engagement and solutions at different system levels may occur at both the interpersonal and organisational levels. This strategy has already proven successful in several international childhood obesity prevention interventions. The participatory system dynamics approach remains to be tested in a large-scale Danish context. During the past year, our research group has tested the participatory system dynamics approach in different settings in Denmark. We propose to conduct a participatory system dynamics trial across ten communities in five municipalities to create local solutions to promote healthy PA behaviour in Danish schoolchildren through Child-COOP.
AIM
The overall aim is to evaluate a participatory system dynamics approach to promote (increase and sustain) healthy PA behaviour in 6- to 12-year-old schoolchildren in local communities in Denmark through the following sub-aims:
- Measuring the effectiveness on the children's PA behaviour by assessing changes in time spent sedentary and time spent at light, moderate and vigorous intensity at three-year follow-up
- Estimating changes at system level such as assessing changes in community systems, community networks structure, policy and practice at three-year follow-up
- Identifying health-economic implications by assessing both a cost consequence analysis and an explorative analysis of the derived effects at three-year follow-up
- Conducting a process evaluation to map a final systems program theory on "what works for whom under what circumstances" to be used as a framework in future recommendations and up-scaling.
TRIAL COMPONENTS
The Child-COOP trial consists of three stages:
Stage 1: Preparation: selection of communities, training and monitoring (12 months) Selection of communities: The communities will be selected and defined by the municipalities based on their local challenges related to children's PA behaviour, socially deprived areas and motivation.
Training: Employees from all participating municipalities will receive training in how to run local community initiatives based on a participatory system dynamics approach. The target group for the training is Child-COOP municipal coordinators and other employees in the municipality taking part in the project. The training will consist of seminars and homework. The purpose of the training is to build capacity for municipal employees to understand and act within the framework of the participatory system dynamics approach and to solve complex health challenges regarding children's PA behaviour.
Monitoring: A local childhood health profile will be generated to outline daily PA behaviour, sleep patterns and leisure time activities at baseline (based on survey and objective data) and factors associated with PA behaviour in children, e.g. mental health, screen use and parental support. This profile will be generated at baseline based on survey and objective data (see details in "Individual level: data collection and measurements").
Stage 2: Recruitment, group model building (GMB) and systems mapping (9 months) Recruitment of key leaders and local stakeholders: A coordinator from each municipality will together with the research team identify and recruit key leaders (e.g. local politicians, department heads, municipality leaders) and local stakeholders (e.g. school board members, school principal, school nurse, sport club representatives). Key leaders and local stakeholders will be selected based on authority and capacity to initiate actions that are likely to influence the children's PA behaviour across sectors and organisations. During this stage, key leaders must commit to allocate resources to ensure subsequent implementation. The aim is to recruit 12-15 key leaders and local stakeholders from each community.
GMB process and systems mapping: During this stage, three workshops (WS1, WS2 and WS3) will be held at each participating community. WS1 and WS2 will engage the key leaders and stakeholders, and local childhood health data will be presented to provide the first critical engagement step. In these two workshops, the key leaders and stakeholders will map the system by building a causal loop diagram (CLD) to understand how the perceived local system affects the children's daily PA behaviour in their community. In WS3, all community members willing to engage in changing the local system will be invited to identify priority areas for action based on the developed CLD from WS1 and WS2.
Stage 3: Implementation of actions, support and monitoring (24-30 months) Actions and support: The output of WS3 is the formation of local working groups that will focus on implementing the chosen actions. The working groups will be supported and supervised by a backbone office consisting of the Child-COOP municipality coordinator(s) and the research team. A follow-up workshop (WS4) will be held with the key stakeholders six months after completion of WS3 to review the consolidated priority actions. To increase and maintain motivation and actions in the local community, subsequent follow-up meetings will be held with the working groups when needed during the 24-30 months after WS3.
Monitoring: Survey childhood health data will be collected from the study population on an annual basis and from the newly enrolled schoolchildren (first grade) every year (see details in "Individual level: data collection and measurements"). At an annual meeting in each community, these data on the children's health and well-being in the local community will be presented to actions groups, key leaders and stakeholders to sustain and promote engagement.
RESEARCH PLAN
Child-COOP will be evaluated through an assessment of outcomes at individual and systems level, process and economic implications. Combined, these three elements will give an essential understanding of what it would require to upscale Child-COOP to regional or national level. Few guidelines exist on how to evaluate public health programs in complex adaptive systems. Child-COOP is inspired by both the Medical Research Council recent evaluation guidelines for process evaluations of complex interventions and the newly developed ENCOMPASS framework aiming to generate a comprehensive, yet practically realistic evaluation. The evaluation will be structured along the realist research cycle, and a critical first step is to develop an initial program theory to inform how the participatory system dynamics intervention is expected to produce change. Given the participatory approach in Child-COOP, the exact outcomes and actions are unknown in advance. Consequently, the evaluation will be constructed to allow for systematic documentation of processes and outcomes. A final systems program theory on "what works for whom under what circumstances" based on the participatory systems dynamic approach will be made, including recommendations for large-scale implementation across different settings.
System level: data collection and measurements
Engagement and commitment will be measured by a survey to document changes at community and organizational level. The survey will be distributed to all participants attending workshops and will enrol new workings groups' members continuously at base line (defined as first attendance) after one year and at two-year follow-up.
Participatory mapping of communities will be assessed through online workshops with the participants attending the workshops. The online workshops will supplemented by survey data provide evaluation and formative insight into the local network of each community.
Actions implemented will be evaluated by using Ripple Effects Mapping method which asses the number of actions and where they have been initiated in the system. Action Scales Model is used to asses leverage point of each action implemented. Both methods will be used in workshops with working groups every 6 months for a two-year period.
Change in local systems will be understood through Causal loop diagrams (CLDs) built during the GMB workshops, which will be enriched with observation data from the workshops and survey data to quantify actions, collaborations and system changes over time and to assess the impact of actions and networks on variables in the system. To support the GMB method, the software program "Systems Thinking in Community Knowledge Exchange" (STICKE) will be used together with internationally developed, tested and standardised scripts.
Process evaluation: data collection and measurements
Quantitative data for the process evaluation will be collected with the same procedures as described at system level (to assess reach). Moreover, we will also use the results of "ripple effect mapping" (REM) to understand the solutions and actions developed in the local communities. Additional data will be collected through interviews, focus groups, structured observations and follow-up interviews before, during and after the GMB workshops to access the overall process. The process evaluation will also include structured observations/checklists collected during workshops (to assess dose). Interviews or focus group discussions with workshop participants and participants dropping out of the GMB processes will be used to assess participant responsiveness. These data will be used to understand the mechanisms in Child-COOP. Furthermore, adherence to the participatory system dynamics approach will be assessed by routinely (every 6 months) collected information regarding implementation, engagement and actions of key leaders and stakeholders, political will and advocacy. In addition adherence, dose, quality of delivery, participant responsiveness and reach will be assessed to gain knowledge on how the participatory system dynamics approach was delivered and implemented and to inform a final program theory.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design: A wait-list design will be applied to assess three-year effectiveness of the participatory system dynamics approach to promote (increase and sustain) healthy physical activity behaviour among approximately 3000 children aged 6- to 12 years. Five municipalities have agreed to participate: two in the Central Denmark Region, one in the Capital Region of Denmark and two in the Zealand Region. Each municipality will allocate two communities to be either intervention or comparison community. According to the wait-list design, the participatory system dynamics approach will be implemented in the comparison community by the municipal staff after follow-up.
| Arm | Type | Receives |
|---|---|---|
| Intervention communities | Experimental | Other: Participatory system dynamics approachA participatory system dynamics approach will be implemented by the municipal staff and research group. |
| Comparison communities | No intervention | –No intervention will be applied, but according to the wait-list design, the participatory system dynamics approach will be implemented in the comparison community by the municipal staff after follow-up. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children from grade 1 (aged 6-7 years) to grade 6 (aged 11-12 years) at the participating schools
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory system dynamics approachAlso: Group Model BuildingFirst, local health profiles of children will be collected and used to engage key leaders and stakeholders from intervention communities and municipal administrations in participatory processes. These will be used to develop a systems map of drivers of PA behaviour in schoolchildren aged 6-12 years in the local communities. Second, based on the systems map, stakeholders from the civic and private sectors will be involved in developing and implementing actions to promote healthy PA behaviour through system changes. | Other | Intervention communities |
Primary outcome
Between group change in total movement time (children)
Time frame: Measured at baseline and at 3 year follow-up.
Total daily time the children spent moving in different body positions and engaging in different physical activities (standing, walking, running and biking). To asses changes in total movement, movement behaviour will be measured with thigh worn accelerometers (Axivity AX3) for 8 consecutive days.
Between group change in time spent being sedentary (children)
Time frame: Measured at baseline and at 3 year follow-up.
Sedentary time is defined as any waking activity characterized as being in a sitting, reclining or lying posture with minimal stationary movement. Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3).
Between group change in time being moderate to vigorous physical active (MVPA) (children)
Time frame: Measured at baseline and at 3 year follow-up.
Activity is measured for 8 consecutive days at baseline and follow-up using thigh worn accelerometry (Axivity AX3) (www.hbsc.dk/download/HBSC-Fysisk-aktivitet-monitorering-2022.pdf page 17).
16 secondary outcomes
Between group change in total evening and night reclining as a measure of sleep duration (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in proportion meeting the sleep guidelines (children)
Time frame: Measured at baseline and at 3 year follow-up.
Fitness level (children)
Time frame: Measured at baseline and at 3 year follow-up.
Strength level (children)
Time frame: Measured at baseline and at 3 year follow-up.
Leg power (children)
Time frame: Measured at baseline and at 3 year follow-up.
Coordination (children)
Time frame: Measured at baseline and at 3 year follow-up.
Physical literacy (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in BMI z-scores (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in weight status in %
Time frame: Measured at baseline and at 3 year follow-up.
Change in the overweight and obesity prevalence calculated using the WHO cut points (children)
Time frame: Measured at baseline and at 3 year follow-up.
Health-related quality of life (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of fruit consumed weekly (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of non-core (discretionary) foods consumed weekly (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of sugar-sweetened beverages consumed weekly (children)
Time frame: Measured at baseline and at 3 year follow-up.
Change in typical/usual serves of vegetable weekly (children)
Time frame: Measured at baseline and at 3 year follow-up.
Height
Time frame: Measured at baseline and at 3 year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 34340663Melby PS, Elsborg P, Nielsen G, Lima RA, Bentsen P, Andersen LB. Exploring the importance of diversified physical activities in early childhood for later motor competence and physical activity level: a seven-year longitudinal study. BMC Public Health. 2021 Aug 2;21(1):1492. doi: 10.1186/s12889-021-11343-1.
- Background: PubMed 17555542Kristensen PL, Moller NC, Korsholm L, Wedderkopp N, Andersen LB, Froberg K. Tracking of objectively measured physical activity from childhood to adolescence: the European youth heart study. Scand J Med Sci Sports. 2008 Apr;18(2):171-8. doi: 10.1111/j.1600-0838.2006.00622.x. Epub 2007 Jun 6.
- Background: PubMed 26315694Ryan DJ, Stebbings GK, Onambele GL. The emergence of sedentary behaviour physiology and its effects on the cardiometabolic profile in young and older adults. Age (Dordr). 2015 Oct;37(5):89. doi: 10.1007/s11357-015-9832-7. Epub 2015 Aug 28.
- Background: PubMed 30728623Rutter H, Cavill N, Bauman A, Bull F. Systems approaches to global and national physical activity plans. Bull World Health Organ. 2019 Feb 1;97(2):162-165. doi: 10.2471/BLT.18.220533. Epub 2018 Dec 19. No abstract available.
- BackgroundHovmand P. Community based systems dynamics. 1. ed. New York: Springer-Verlag; 2014
- Background: PubMed 31359617Allender S, Brown AD, Bolton KA, Fraser P, Lowe J, Hovmand P. Translating systems thinking into practice for community action on childhood obesity. Obes Rev. 2019 Nov;20 Suppl 2(Suppl 2):179-184. doi: 10.1111/obr.12865. Epub 2019 Jul 29.
- Background: PubMed 35346233Luna Pinzon A, Stronks K, Dijkstra C, Renders C, Altenburg T, den Hertog K, Kremers SPJ, Chinapaw MJM, Verhoeff AP, Waterlander W. The ENCOMPASS framework: a practical guide for the evaluation of public health programmes in complex adaptive systems. Int J Behav Nutr Phys Act. 2022 Mar 28;19(1):33. doi: 10.1186/s12966-022-01267-3.
- Background: PubMed 35300619Nobles J, Wheeler J, Dunleavy-Harris K, Holmes R, Inman-Ward A, Potts A, Hall J, Redwood S, Jago R, Foster C. Ripple effects mapping: capturing the wider impacts of systems change efforts in public health. BMC Med Res Methodol. 2022 Mar 18;22(1):72. doi: 10.1186/s12874-022-01570-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Nautrup N Østergaard, PhD principal investigator
Steno Diabetes Center Aarhus, Aarhus University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory system dynamics approach in people with Child Health and Child Behavior, run by Aarhus University Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group change in total movement time (children) (time frame: Measured at baseline and at 3 year follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185413, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.