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Randomized Controlled Trial
. 2017 Aug 29;18(1):400.
doi: 10.1186/s13063-017-2143-9.

Influence of motor skills training on children's development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study

Affiliations
Randomized Controlled Trial

Influence of motor skills training on children's development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study

Lise Hestbaek et al. Trials. .

Abstract

Background: Good motor skills are considered important for children's physical, social, and psychological development, but the relationship is still poorly understood. Preschool age seems to be decisive for the development of motor skills and probably the most promising time-window in relation to preventive strategies based on improved motor skills. This research program has four overall aims: (1) investigation of the effect of a structured program aimed at improving motor skills in 3-6-year-old children on current and future motor skills, health, cognition, and wellbeing; (2) establish reference data on motor skills in 3-6-year-olds; (3) description of early development of musculoskeletal problems; and (4) establishment of a population-based cohort of 3-6-year-olds.

Methods: Over a four-year period, all preschools in a Danish municipality, Svendborg, will implement a new program aimed at optimizing children's motor skills. By introducing the program into a subset of the preschools at onset and comparing these children to another subset (control) that will not receive the intervention the first three years, it is possible to document a potential effect of the intervention. At the same time, a cohort will be established including all children attending preschools in the municipality with extensive baseline data collection: gross and fine motor skills; movement patterns; musculoskeletal complaints; physical activity; anthropometry; general wellbeing; cognitive abilities; language status; medical history; demographic background; and more. The children are aged 3-6 years at baseline. A total of 1461 children have been invited into the cohort, 368 to the intervention arm and 359 to the control arm. Follow-up time for the trial is 2.5 years. The cohort is planned to run at least until the children leave school at age 15-16 years. Longer follow-up will depend on future funding.

Discussion: If the results of the trial are positive, the intervention can be implemented in other similar settings with reasonable ease and at a relatively low initial cost. This is due to the extensive end-user involvement, the broad population base, and the pragmatic nature of the intervention. The cohort will provide important information about the influence of early motor skills on children's development across many domains and the potential interactions between these domains.

Trial registration: ISRCTN registry, ISRCTN23701994 . Registered on 13 October 2016.

Keywords: Children; Cognitive development; Kindergarten; Motor skills; Musculoskeletal; Physical activity; Preschool; Wellbeing.

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Conflict of interest statement

Authors’ information

The SPIRIT checklist can be seen in Additional file 3.

Ethics approval and consent to participate

The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-2015-0178) as well as by the Danish Data protection Agency (2015-57-0008). This approval covered all participating centers (preschools).

Individual ethical approval from preschools was not required.

Important protocol modifications will be communicated to the abovementioned organizations by the first author who is also primary investigator.

The parents have signed/will sign an informed consent form on behalf of the children as required by the Committee on Health Research ethics. No children will be included without written parental consent.

The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-2015-0178) as well as by the Danish Data protection Agency (2015-57-0008). This approval covered all participating centers (preschools).

Individual ethical approval from preschools was not required.

Consent for publication

No data on individual persons will be published.

Competing interests

The authors declare that they have no competing interests

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The MiPS study-DK. Organizational diagram
Fig. 2
Fig. 2
SPIRIT diagram for the schedule of enrolment, interventions, and assessments. *See description of the intervention in main protocol and Additional file 2. **See description of collected variables in main protocol and Additional file 1. 1 includes all the children, i.e. children born in 2011, 2012, or 2013; 2 includes children born in 2012 or 2013, since children from 2011 have left preschool; 3 includes children born in 2013, since children born in 2011 and 2012 have left preschool

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