- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868084
Early Years Physical Activity and Movement Skills Intervention: a Feasibility Study
Early Years Physical Activity and Movement Skills Intervention - Feasibility Study to Evaluate an Existing Training Programme for Early Years Practitioners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Newcastle upon Tyne, United Kingdom, NE1 7RU
- Newcastle University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Physical Literacy in the early years.
The intervention was delivered by an external provider and designed to provide nursery teachers, teaching assistants and others working with children under age five the knowledge, skills and confidence to deliver enjoyable and engaging lessons which focus on the development of core "fundamental" skills.
The course was developed in conjunction with leading Physical Education (PE) consultants, Sports Scientists and Office for Standards in Education, Children's Services and Skills (Ofsted) advisors which covered both the theory about FMS and physical literacy, and practical demonstrations of age-appropriate ways to teach and develop FMS.
Staff from the Intervention settings received the six-hour training session.
After the training session, school nurseries which were encouraged to speak with the training provider to follow-up the understanding of the training and provide additional help for implementation of the practice learned.
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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.
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No Intervention: Control
The control nurseries followed their usual practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fundamental motor skills (FMS)
Time Frame: Baseline and 6 months post-intervention
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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.
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Baseline and 6 months post-intervention
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Change in children's physical activity
Time Frame: Baseline and 6 months post-intervention
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Children's physical activity was measured directly using a thigh-mounted accelerometer (ActivPAL) for 7 days
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Baseline and 6 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in body mass index z-score
Time Frame: Baseline and 6 months post-intervention
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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
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Baseline and 6 months post-intervention
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Change in practitioner behaviour
Time Frame: Baseline and 6 months post-intervention
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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.
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Baseline and 6 months post-intervention
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Change in knowledge of the physical activity guidelines
Time Frame: Baseline and 6 months post-intervention
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Knowledge of the physical activity guidelines and benefits of physical activity for early years was assessed by a customised questionnaire
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Baseline and 6 months post-intervention
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Change in intentions for behaviour change
Time Frame: Baseline and 6 months post-intervention
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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
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Baseline and 6 months post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Laura Basterfield, PhD, Newcastle University
Publications and helpful links
Helpful Links
- Huijg JM, Gebhardt WA, Crone MR, Dusseldorp E, Presseau J. Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research. Implement Sci. 2014 Jan 15;9:11.
- Cole TJ, Freeman JV, Preece MA. Body mass index reference curves for the UK, 1990. Arch Dis Child. 1995 Jul;73(1):25-9
- Henderson SE, Sugden DA, Barnett AL. Movement assessment battery for children-2. Second edition (Movement ABC-2). London: The Psychological Corporation; 2007
- Dockrell, J. (2012). Developing a communication supporting classrooms observation tool.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Early years physical activity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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