Physical Inactivity Clinical Trial
— Child-COOPOfficial 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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - All children from grade 1 (aged 6-7 years) to grade 6 (aged 11-12 years) at the participating schools Exclusion Criteria: - No |
Country | Name | City | State |
---|---|---|---|
Denmark | Halsnæs Municipality | Hundested | |
Denmark | Vordingborg municipality | Lundby | |
Denmark | Randers Municipality | Randers | |
Denmark | Syddjurs municipality | Skørring | |
Denmark | Odsherred Municipality | Vig |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | Deakin University, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, University of Aarhus |
Denmark,
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. — View Citation
Hovmand P. Community based systems dynamics. 1. ed. New York: Springer-Verlag; 2014
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Estimating the cost-effectiveness of the trial | Cost-effectiveness analysis (CEA) will measure costs per increment in total movement time (study primary out-come). Methods for the economic evaluation will be based on: Sweeney R, Moodie M, Nguyen P, et al Protocol for an economic evaluation of WHO STOPS childhood obesity stepped-wedge clus-ter randomised controlled trial. BMJ Open 2018;8:e020551. doi: 10.1136/bmjopen-2017-020551 | Measured at baseline and at 3 year follow-up. | |
Other | Estimating the cost-utility of the trial | Cost-utility analysis (CUA) will measure the cost per quality adjusted life year (QALY, based on the CHU-9D) gained. Methods for the economic evaluation will be based on: Sweeney R, Moodie M, Nguyen P, et al Pro-tocol for an economic evaluation of WHO STOPS childhood obesity stepped-wedge clus-ter randomised controlled trial. BMJ Open 2018;8:e020551. doi: 10.1136/bmjopen-2017-020551 | Measured at baseline and at 3 year follow-up. | |
Other | Participatory mapping / Working network (system) | Change in patterns over time Clarifying roles Levels of commitment The partnership analysis tool | Measured at baseline and at 1 and 2 years of follow-up | |
Other | Actions implemented (system) | Number of actions implemented Leverage points REM (Rippled effects mapping)
ASM (Action Scales Model) Add action variables within system dynamics software (STICKE) |
Measured at baseline and 1, 2 and 3 year of follow-up | |
Other | Change in system maps (system) | Systems maps using STICKE
Framework for a process evaluation from a complex systems perspective (McGill, 2021) System maps revisited using STICKE |
Measured at baseline and 1, 2 and 3 year of follow-up | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | Strength level (children) | Strength will be measured using a hand-grip dynamometer | Measured at baseline and at 3 year follow-up. | |
Secondary | Leg power (children) | Leg power will be measured using standing long jump test | Measured at baseline and at 3 year follow-up. | |
Secondary | Coordination (children) | Number of side-jumps in 30 seconds | Measured at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | Change in BMI z-scores (children) | Data is collected via a portable stadiometer and bioimpedance digital scale (InBody270). | Measured at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | 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 at baseline and at 3 year follow-up. | |
Secondary | Height | Between group difference in change in standing height measured using a portable stadiometer. | Measured at baseline and at 3 year follow-up. |
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