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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04868084
Other study ID # Early years physical activity
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2017
Est. completion date January 31, 2019

Study information

Verified date February 2021
Source Newcastle University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project aims to test the feasibility of using an existing training course for nursery practitioners (those that care for children aged under 5 years) to improve their ability and confidence to teach fundamental movement skills to the children they care for. 'Fundamental movement skills', or FMS, are based on agility, balance and coordination, and include jumping, throwing, catching, striking and running and are vital for children's involvement in, and enjoyment from, physical activities and sports. The intervention consists of a one-day course given by specialist providers, specifically for those who work with children under 5. The intervention aims to increase practitioner knowledge and awareness, and increase confidence in their ability to provide age-appropriate guidance and settings for FMS and active play. The implication from the training is that the children's FMS and overall physical activity will increase, whilst decreasing time spent in sedentary behaviours. A long-term aim of the project would be the maintenance of a healthy weight by the children and increase in self-efficacy for physical activity. The benefits of the study, therefore, are an increase in practitioner confidence and knowledge, and a positive change in their behaviour during their everyday practice. As this is a feasibility study, the main objective is whether a full trial would be feasible. The primary outcomes are therefore 1. Recruitment (ratio of consented participants to potentially eligible participants approached) 2. Numbers completing study 3. Numbers completing study questionnaires 4. Acceptability of the intervention to participants.


Description:

This is a pilot non-randomised controlled trial. The study was approved by the Newcastle University Research Ethics Committee (application number:01223/9764/2016). The intervention consists of a one-day course given by specialist providers, specifically for those who work with children under 5. The training consisted on helping practitioners around fundamental movement skills (balancing, jumping throwing, catching kicking) and helping them to develop a better understanding about the importance of physical activity for early years. The training also covered an introduction to the United Kingdom (UK) physical activity guidelines and how practitioners could translate the physical activity guidelines into practice. The course used an ecological model approach in the delivery of the intervention. The programme provided ideas for: creating enabling environments for physical activity; planning physical activity for all stages of development; balance child-initiated and adult-led physical activities; encourage parent and carer support and promotion of physical activity beyond the nursery setting. Data collection took place between February 2017 and June 2018. All nurseries and schools with nurseries in the Middlesbrough area were eligible to participate and were invited to take part. The following measures were intended to be collected pre-intervention and 6 months post-intervention (follow-up). Practitioner behaviour was assessed by direct observation adapted from the Communication Supporting Classroom Observation Tool. Each observation lasted approximately 30 min and was conducted by one of the researchers. Knowledge of the physical activity guidelines and benefits of physical activity for early years was assessed by a customised questionnaire. Intentions for behaviour change was assessed by a questionnaire which covered the following domains: Knowledge; Skills; Social/Professional Role & Identity; Belief about Capabilities; Optimism; Beliefs about Consequences; Intentions; Goals- Action Planning; Goals - Priorities; Memory, Attention & Decision Processes; Environmental Context & Resources; Social Influences; Emotion; Behavioural Regulation; Social & Professional Role; Work Environment. Children. Physical activity was measured directly using a thigh-mounted accelerometer (activPAL) which has been validated in young children. Time in sitting, standing and stepping postures was measured during school or nurseries hours. Data were recorded in 15 s epoch and reduced to the percentage of wear time in each of the postures, to account for potential differences in wear time within and between participants. Height (to 0.1cm) and weight (to 0.1kg) were measured twice without socks or shoes, in indoor clothing. BMI was then derived, and z -scores created relative to UK 1990 data. Fundamental movement skills were assessed with the Movement Assessment Battery for Children 2 (Movement ABC-2) which covers fine and gross motor tasks, manual dexterity and balance. Process evaluation. Using focus groups, interviews and a questionnaire with all stakeholders explored the reasons for participation/non-participation of practitioners and families; participants' views and perceptions of the intervention in terms of acceptability, feasibility and usability. All data were exported to SPSS for analyses. Descriptive statistics for all variables of interest were generated


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 31, 2019
Est. primary completion date June 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 4 Years
Eligibility Inclusion Criteria: - Children who are 3 to 4 years old at the time of data collection. - Children who received parent/guardian consent. - Children who provided assent to take part in the study. Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
Physical literacy in the early years
Intervention nurseries received a 6-hour training session, covering the theory about FMS and practical demonstrations of age-appropriate ways to teach and develop FMS.

Locations

Country Name City State
United Kingdom Newcastle University Newcastle upon Tyne

Sponsors (3)

Lead Sponsor Collaborator
Newcastle University Teesside University, University of Huddersfield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fundamental motor skills (FMS) FMS, assessed with the Movement Assessment Battery for Children-2 which covers fine and gross motor tasks, manual dexterity and balance. Standard scores are translated to reference percentiles. Low percentiles indicate movement difficulties. Baseline and 6 months post-intervention
Primary Change in children's physical activity Children's physical activity was measured directly using a thigh-mounted accelerometer (ActivPAL) for 7 days Baseline and 6 months post-intervention
Secondary Change in body mass index z-score Height (to 0.1cm) and weight (to 0.1kg) were measured twice without socks or shoes, in indoor clothing. BMI was then derived, and z -scores created relative to UK1990 data Baseline and 6 months post-intervention
Secondary Change in practitioner behaviour Practitioner behaviour was assessed by direct observation adapted from the Communication Supporting Classroom Observation Tool from the communication trust. Each observation lasted approximately 30 min and was conducted by one of the researchers. Baseline and 6 months post-intervention
Secondary Change in knowledge of the physical activity guidelines Knowledge of the physical activity guidelines and benefits of physical activity for early years was assessed by a customised questionnaire Baseline and 6 months post-intervention
Secondary Change in intentions for behaviour change Questionnaire adapted from Huijg et al. (2014) which covered the following domains: Knowledge; Skills; Social/ Professional Role & Identity; Belief about Capabilities; Optimism; Beliefs about Consequences; Intentions; GoalsAction Planning; Goals - Priorities; Memory, Attention & Decision Processes; Environmental Context & Resources; Social Influences; Emotion; Behavioural Regulation; Social & Professional Role; Work Environment. Children Baseline and 6 months post-intervention
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