Increasing Children's physical Activity by Policy (CAP) in preschools within the Stockholm region: study protocol for a pragmatic cluster-randomized controlled trial

C Chen, V H Ahlqvist, P Henriksson, J H Migueles, F Christiansen, M R Galanti, D Berglind, C Chen, V H Ahlqvist, P Henriksson, J H Migueles, F Christiansen, M R Galanti, D Berglind

Abstract

Background: Systematic reviews suggest that preschool environmental/organizational changes may be effective in increasing physical activity (PA) levels of preschool children, but evidence is scarce regarding feasible, effective, and equitable interventions that can be scaled up. Specifically, it is essential to understand whether introducing a multicomponent organizational change in terms of policy in the preschool context may be beneficial for children's PA levels and concomitant health outcomes. To bridge this knowledge gap, our main aim is to examine the feasibility and effectiveness of a policy package in increasing PA levels in preschool children, using a large-scale pragmatic cluster-randomized controlled trial.

Methods: This proposed study is a pragmatic cluster-randomized controlled trial with two conditions (intervention and control with a 1:1 ratio) with preschools as clusters and the unit of randomization. We aim to recruit approximately 4000 3-5-year-old children from 90 preschools and retain more than 2800 children from 85 preschools to provide adequate statistical power for the analyses. The intervention to implement is a co-created, multicomponent policy package running for 6 months in preschools randomized to intervention. Change in accelerometer measured PA levels in children between intervention and control from pre- and post-intervention will be the primary outcome of the study, while secondary outcomes include health outcomes such as musculoskeletal fitness, psychosocial functioning, and absence due to illness in children among others. Implementation will be studied carefully using both quantitative (dose, fidelity) and qualitative (interview) methodologies. The change in primary and secondary outcomes, from pre- to post-intervention, will be analyzed with linear mixed-effect models (to allow both fixed and random effects) nested on a preschool level.

Discussion: This is a large-scale co-creation project involving the City of Stockholm, childcare stakeholders, preschool staff, and the research group with the potential to influence more than 30,000 preschool children within the Stockholm area. The study will add reliable evidence for the implementation of PA policies at the organizational level of preschools and clarify its potential effect on objectively measured PA and health markers in children.

Trial registration: ClinicalTrials.gov NCT04569578 . Prospectively registered on September 20, 2020.

Keywords: Accelerometer-based measurement; Cluster-randomized controlled trial; Intervention; Physical activity; Policy; Preschool.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of study recruitment, randomization, and follow-up
Fig 2
Fig 2
SPIRIT figure for schedule of enrollment, intervention, and assessment

References

    1. Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1·9 million participants. Lancet Glob Health. 2018;6(10):e1077–e1e86.
    1. Tremblay MS, Gray CE, Akinroye K, Harrington DM, Katzmarzyk PT, Lambert EV, et al. Physical activity of children: a global matrix of grades comparing 15 countries. J Phys Act Health. 2014;11(Suppl 1):S113–S125.
    1. Carson V, Lee EY, Hewitt L, Jennings C, Hunter S, Kuzik N, et al. Systematic review of the relationships between physical activity and health indicators in the early years (0-4 years) BMC Public Health. 2017;17(Suppl 5):854.
    1. Saunders TJ, Chaput JP, Tremblay MS. Sedentary behaviour as an emerging risk factor for cardiometabolic diseases in children and youth. Can J Diabetes. 2014;38(1):53–61.
    1. Smith JJ, Eather N, Morgan PJ, Plotnikoff RC, Faigenbaum AD, Lubans DR. The health benefits of muscular fitness for children and adolescents: a systematic review and meta-analysis. Sports Med. 2014;44(9):1209–1223.
    1. Jones RA, Hinkley T, Okely AD, Salmon J. Tracking physical activity and sedentary behavior in childhood: a systematic review. Am J Prev Med. 2013;44(6):651–658.
    1. Huotari P, Nupponen H, Mikkelsson L, Laakso L, Kujala U. Adolescent physical fitness and activity as predictors of adulthood activity. J Sports Sci. 2011;29(11):1135–1141.
    1. Steene-Johannessen J, Hansen BH, Dalene KE, Kolle E, Northstone K, Moller NC, et al. Variations in accelerometry measured physical activity and sedentary time across Europe - harmonized analyses of 47,497 children and adolescents. Int J Behav Nutr Phys Act. 2020;17(1):38.
    1. Nyberg G, Kjellenberg K, Fröberg A, Lindroos AK. A national survey showed low levels of physical activity in a representative sample of Swedish adolescents. Acta Paediatr. 2020;109(11):2342–2353.
    1. Berglind D, Tynelius P. Objectively measured physical activity patterns, sedentary time and parent-reported screen-time across the day in four-year-old Swedish children. BMC Public Health. 2017;18(1):69.
    1. Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes. 2008;32(1):1–11.
    1. Tomkinson GR, Lang JJ, Tremblay MS. Temporal trends in the cardiorespiratory fitness of children and adolescents representing 19 high-income and upper middle-income countries between 1981 and 2014. Br J Sports Med. 2019;53(8):478–486.
    1. Westerstahl M, Barnekow-Bergkvist M, Hedberg G, Jansson E. Secular trends in body dimensions and physical fitness among adolescents in Sweden from 1974 to 1995. Scand J Med Sci Sports. 2003;13(2):128–137.
    1. Swedish National Agency for Education. Statistics on preschool children and staff. Accessed July 2020
    1. Boldemann C, Blennow M, Dal H, Martensson F, Raustorp A, Yuen K, et al. Impact of preschool environment upon children's physical activity and sun exposure. Prev Med. 2006;42(4):301–308.
    1. Forssell G, Hakånsson A, Månsson N-O. Risk factors for respiratory tract infections in children aged 2-5 years. Scand J Prim Health Care. 2001;19(2):122–125.
    1. Chastin SFM, Abaraogu U, Bourgois JG, Dall PM, Darnborough J, Duncan E, et al. Effects of regular physical activity on the immune system, vaccination and risk of community-acquired infectious disease in the general population: systematic review and meta-analysis. Sports Med. 2021;51(8):1673–1686.
    1. Bondestam M, Rasmussen F. Preschool children’s absenteeism from Swedish municipal day-care centres because of illness in 1977 and 1990. Geographical variations and characteristics of the day-care centres. Scand J Soc Med. 1994;22(1):20–26.
    1. Mygind O, Rønne T, Søe A-L, Wachmann CH, Ricks P. Comparative intervention study among Danish daycare children: the effect on illness of time spent outdoors. Scand J Public Health. 2003;31(6):439–443.
    1. Amlani NM, Munir F. Does physical activity have an impact on sickness absence? A review. Sports Med. 2014;44(7):887–907.
    1. Gordon ES, Tucker P, Burke SM, Carron AV. Effectiveness of physical activity interventions for preschoolers: a meta-analysis. Res Q Exerc Sport. 2013;84(3):287–294.
    1. Messing S, Rutten A, Abu-Omar K, Ungerer-Rohrich U, Goodwin L, Burlacu I, et al. How can physical activity be promoted among children and adolescents? A systematic review of reviews across settings. Front Public Health. 2019;7:55.
    1. Coe DP. Means of optimizing physical activity in the preschool environment. Am J Lifestyle Med. 2020;14(1):16–23.
    1. Kracht CL, Webster EK, Staiano AE. A natural experiment of state-level physical activity and screen-time policy changes early childhood education (ECE) centers and child physical activity. BMC Public Health. 2020;20(1):387.
    1. Bower JK, Hales DP, Tate DF, Rubin DA, Benjamin SE, Ward DS. The childcare environment and children's physical activity. Am J Prev Med. 2008;34(1):23–29.
    1. Bell AC, Finch M, Wolfenden L, Fitzgerald M, Morgan PJ, Jones J, et al. Child physical activity levels and associations with modifiable characteristics in centre-based childcare. Aust N Z J Public Health. 2015;39(3):232–236.
    1. Chen C, Ahlqvist VH, Henriksson P, Magnusson C, Berglind D. Preschool environment and preschool teacher's physical activity and their association with children's activity levels at preschool. PLoS One. 2020;15(10):e0239838.
    1. Wolfenden L, Barnes C, Jones J, Finch M, Wyse RJ, Kingsland M, et al. Strategies to improve the implementation of healthy eating, physical activity and obesity prevention policies, practices or programmes within childcare services. Cochrane Database Syst Rev. 2020;2(2):CD011779.
    1. Carson V, Zhang Z, Kuzik N, Adamo KB, Predy M, Crozier M, et al. The impact of new government childcare accreditation standards on children’s in-care physical activity and sedentary time. BMC Public Health. 2022;22(1):1–17.
    1. Nathan A, Adams E, Trost S, Cross D, Schipperijn J, McLaughlin M, et al. Evaluating the effectiveness of the Play Active policy intervention and implementation support in early childhood education and care: a pragmatic cluster randomised trial protocol. BMC Public Health. 2022;22(1):1–12.
    1. Lehne G, Voelcker-Rehage C, Meyer J, Bammann K, Gansefort D, Brüchert T, et al. Equity impact assessment of interventions to promote physical activity among older adults: a logic model framework. Int J Environ Res Public Health. 2019;16(3):420.
    1. Wiersma R, Haverkamp BF, van Beek JH, Riemersma AMJ, Boezen HM, Smidt N, et al. Unravelling the association between accelerometer-derived physical activity and adiposity among preschool children: a systematic review and meta-analyses. Obes Rev. 2020;21(2):e12936.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.
    1. Metcalf B, Henley W, Wilkin T. Effectiveness of intervention on physical activity of children: systematic review and meta-analysis of controlled trials with objectively measured outcomes (EarlyBird 54) BMJ. 2012;345:e5888.
    1. Halvorsrud K, Kucharska J, Adlington K, Rüdell K, Brown Hajdukova E, Nazroo J, Haarmans M, Rhodes J, Bhui K. Identifying evidence of effectiveness in the co-creation of research: a systematic review and meta-analysis of the international healthcare literature. J Public Health (Oxf). 2021;43(1):197-208. 10.1093/pubmed/fdz126.
    1. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.
    1. Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nystrom C, Mora-Gonzalez J, Lof M, et al. Accelerometer data collection and processing criteria to assess physical activity and other outcomes: a systematic review and practical considerations. Sports Med. 2017;47(9):1821–1845.
    1. Migueles JH, Rowlands AV, Huber F, Sabia S, van Hees VT. GGIR: A research community–driven open source R package for generating physical activity and sleep outcomes from multi-day raw accelerometer data. J Measure Phys Behav. 2019;2(3):188–196.
    1. Hildebrand M, Hansen BH, van Hees VT, Ekelund U. Evaluation of raw acceleration sedentary thresholds in children and adults. Scand J Med Sci Sports. 2017;27(12):1814–1823.
    1. Hildebrand M, Van Hees VT, Hansen BH, Ekelund ULF. Age group comparability of raw accelerometer output from wrist- and hip-worn monitors. Med Sci Sports Exerc. 2014;46(9):1816–1824.
    1. Gu F, Khoshelham K, Shang J, Yu F, Wei Z. Robust and accurate smartphone-based step counting for indoor localization. IEEE Sensors J. 2017;17(11):3453–3460.
    1. Collings PJ, Brage S, Ridgway CL, Harvey NC, Godfrey KM, Inskip HM, et al. Physical activity intensity, sedentary time, and body composition in preschoolers. Am J Clin Nutr. 2013;97(5):1020–1028.
    1. Gomersall SR, Rowlands AV, English C, Maher C, Olds TS. The activitystat hypothesis. Sports Med. 2013;43(2):135–149.
    1. Ortega FB, Cadenas-Sánchez C, Sánchez-Delgado G, Mora-González J, Martínez-Téllez B, Artero EG, et al. Systematic review and proposal of a field-based physical fitness-test battery in preschool children: the PREFIT battery. Sports Med. 2015;45(4):533–555.
    1. Gustafsson BM, Gustafsson PA, Proczkowska-Bjorklund M. The Strengths and Difficulties Questionnaire (SDQ) for preschool children-a Swedish validation. Nord J Psychiatry. 2016;70(8):567–574.
    1. van Hees VT, Sabia S, Jones SE, Wood AR, Anderson KN, Kivimaki M, et al. Estimating sleep parameters using an accelerometer without sleep diary. Sci Rep. 2018;8(1):12975.
    1. Salomonsson B, Sleed M. The Ages & Stages Questionnaire: Social-Emotional: a validation study of a mother-report questionnaire on a clinical mother-infant sample. Infant Ment Health J. 2010;31(4):412–431.
    1. Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000;320(7244):1240–1243.
    1. Cadenas-Sanchez C, Martinez-Tellez B, Sanchez-Delgado G, Mora-Gonzalez J, Castro-Piñero J, Löf M, et al. Assessing physical fitness in preschool children: Feasibility, reliability and practical recommendations for the PREFIT battery. J Sci Med Sport. 2016;19(11):910–915.
    1. Ward D, Mazzucca S, McWilliams C, Hales D. Use of the Environment and Policy Evaluation and Observation as a Self-Report Instrument (EPAO-SR) to measure nutrition and physical activity environments in child care settings: validity and reliability evidence. Int J Behav Nutr Phy. 2015;12(1):124.
    1. Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, et al. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT) BMC Med Res Methodol. 2018;18(1):135.
    1. Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Åberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018;13(1):146.

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