Children's Cooperation Denmark: a 3-year System Dynamics Trial

NCT06185413 | Active Not Recruiting

• 1 other identifier: 790941
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Child Health; Child Behavior; Physical Inactivity; Child Obesity

Keywords

Participatory system dynamics approach; Group Model Building; Children

Outcome Measures

Primary Outcomes (3)

• 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 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 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 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)

  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.

• 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.

Other Outcomes (5)

• Estimating the cost-effectiveness of the trial

  Measured at baseline and at 3 year follow-up.

• Estimating the cost-utility of the trial

  Measured at baseline and at 3 year follow-up.

• Participatory mapping / Working network (system)

  Measured at baseline and at 1 and 2 years of follow-up

Study Arms (2)

Intervention communities

EXPERIMENTAL

A participatory system dynamics approach will be implemented by the municipal staff and research group.

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.

Interventions

Participatory system dynamics approach OTHER

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.

Also known as: Group Model Building

Intervention communities

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• Steno Diabetes Center Copenhagen: collaborator
• Steno Diabetes Center Sjaelland: collaborator
• Deakin University: collaborator

Study Sites (5)

Halsnæs Municipality

Hundested, Denmark

Location

Vordingborg municipality

Lundby, Denmark

Location

Randers Municipality

Randers, Denmark

Location

Syddjurs municipality

Skørring, 8530, Denmark

Location

Odsherred Municipality

Vig, Denmark

Location

Related Publications (8)

• 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.

  PMID: 34340663 BACKGROUND

• Kristensen 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.

  PMID: 17555542 BACKGROUND

• Ryan 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.

  PMID: 26315694 BACKGROUND

• Rutter 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.

  PMID: 30728623 BACKGROUND

• Hovmand P. Community based systems dynamics. 1. ed. New York: Springer-Verlag; 2014

  BACKGROUND

• 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.

  PMID: 31359617 BACKGROUND

• Luna 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.

  PMID: 35346233 BACKGROUND

• Nobles 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.

  PMID: 35300619 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Sedentary Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Nautrup N Østergaard, PhD

  Steno Diabetes Center Aarhus, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Leader

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: December 29, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)