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Clinical Trials/NCT06185413
NCT06185413Active, not recruitingNot Applicable

Children's Cooperation Denmark (Child-COOP): Promoting Healthy Physical Activity Behaviour in Children Aged 6-12 Years: a 3-year System Dynamics Trial

Aarhus University Hospital6 sites in 1 country3,000 target enrollmentStarted: September 13, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
3,000
Locations
6
Primary Endpoint
Between group change in time spent being sedentary (children)

Study Overview

Brief 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. 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All children from grade 1 (aged 6-7 years) to grade 6 (aged 11-12 years) at the participating schools

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 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 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).

Secondary Outcomes

  • Fitness level (children)(Measured at baseline and at 3 year follow-up.)
  • Strength level (children)(Measured at baseline and at 3 year follow-up.)
  • Leg power (children)(Measured at baseline and at 3 year follow-up.)
  • Change in BMI z-scores (children)(Measured at baseline and at 3 year follow-up.)
  • Change in proportion meeting the sleep guidelines (children)(Measured at baseline and at 3 year follow-up.)
  • Coordination (children)(Measured at baseline and at 3 year follow-up.)
  • Physical literacy (children)(Measured at baseline and at 3 year follow-up.)
  • Change in the overweight and obesity prevalence calculated using the WHO cut points (children)(Measured at baseline and at 3 year follow-up.)
  • Health-related quality of life (children)(Measured at baseline and at 3 year follow-up.)
  • Change in typical/usual serves of fruit consumed weekly (children)(Measured at baseline and at 3 year follow-up.)
  • Between group change in total evening and night reclining as a measure of sleep duration (children)(Measured at baseline and at 3 year follow-up.)
  • Change in weight status in %(Measured at baseline and at 3 year follow-up.)
  • Change in typical/usual serves of vegetable weekly (children)(Measured at baseline and at 3 year follow-up.)
  • Change in typical/usual serves of non-core (discretionary) foods consumed weekly (children)(Measured at baseline and at 3 year follow-up.)
  • Change in typical/usual serves of sugar-sweetened beverages consumed weekly (children)(Measured at baseline and at 3 year follow-up.)
  • Height(Measured at baseline and at 3 year follow-up.)

Investigators

Sponsor
Aarhus University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jane Nautrup Østergaard

Program Leader

Aarhus University Hospital

Study Sites (6)

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