Child ObesityNCT04868084
Early Years Physical Activity and Movement Skills Intervention: a Feasibility Study
A study testing Physical literacy in the early years in people with Child Obesity and Activity, Motor, run by Newcastle University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity, Activity, Motor, Physical Activity
- What is being tested?
- Physical literacy in the early years
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Years Physical Activity and Movement Skills Intervention - Feasibility Study to Evaluate an Existing Training Programme for Early Years Practitioners
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.
Read the 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
- Conditions
- Child Obesity, Activity, Motor, Physical Activity
- Being tested
- Physical literacy in the early years
- Keywords
- Practitioner, Fundamental movement skills, Educational training, Early years, Preschool
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical literacy in the early yearsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Physical literacy in the early years |
| Control | No intervention | The control nurseries followed their usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months post-intervention
Change in children's physical activity
Children's physical activity was measured directly using a thigh-mounted accelerometer (ActivPAL) for 7 days
Measured: Baseline and 6 months post-intervention
Secondary outcomes (4)
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
Measured: Baseline and 6 months post-intervention
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.
Measured: Baseline and 6 months post-intervention
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
Measured: Baseline and 6 months post-intervention
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
Measured: Baseline and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start2 Mar 2017
- Primary completion13 Jun 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised before and after pilot feasibility study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Huddersfield, Teesside University
- Responsible party
- Sponsor
- Investigators
- Laura Basterfield, PhD, Study director, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868084
- Sponsor's protocol ID
- Early years physical activity
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This needs to be discussed with other co-authors and be checked with ethics committee from Newcastle University.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Years Physical Activity and Movement Skills Intervention - Feasibility Study to Evaluate an Existing Training Programme for Early Years Practitioners
- ClinicalTrials.gov ID
- NCT04868084
- Acronym / sponsor ID
- Early years physical activity
- Conditions
- Child Obesity, Activity, Motor, Physical Activity
- Keywords
- Practitioner, Fundamental movement skills, Educational training, Early years, Preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- University of Huddersfield, Teesside University
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised before and after pilot feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical literacy in the early yearsPhysical 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. |
| Control | No intervention | –The control nurseries followed their usual practice. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical literacy in the early yearsIntervention nurseries received a 6-hour training session, covering the theory about FMS and practical demonstrations of age-appropriate ways to teach and develop FMS. | Behavioural | Intervention group |
Primary outcome
Change in fundamental motor skills (FMS)
Time frame: Baseline and 6 months post-intervention
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.
Change in children's physical activity
Time frame: Baseline and 6 months post-intervention
Children's physical activity was measured directly using a thigh-mounted accelerometer (ActivPAL) for 7 days
4 secondary outcomes
Change in body mass index z-score
Time frame: Baseline and 6 months post-intervention
Change in practitioner behaviour
Time frame: Baseline and 6 months post-intervention
Change in knowledge of the physical activity guidelines
Time frame: Baseline and 6 months post-intervention
Change in intentions for behaviour change
Time frame: Baseline and 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- 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.Link provided by the sponsor.
- Cole TJ, Freeman JV, Preece MA. Body mass index reference curves for the UK, 1990. Arch Dis Child. 1995 Jul;73(1):25-9Link provided by the sponsor.
- Henderson SE, Sugden DA, Barnett AL. Movement assessment battery for children-2. Second edition (Movement ABC-2). London: The Psychological Corporation; 2007Link provided by the sponsor.
- Individual participant dataSharing planned: No. This needs to be discussed with other co-authors and be checked with ethics committee from Newcastle University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Basterfield, PhD study director
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical literacy in the early years in people with Child Obesity and Activity, Motor, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fundamental motor skills (FMS) (time frame: Baseline and 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.