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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 February 2020 |
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Main ID: |
ISRCTN54165860 |
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Date of registration:
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05/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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'Pre-schoolers in the Playground' (PiP) - physical activity for children aged 18 months to 4 years old
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Scientific title:
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'Pre-schoolers in the Playground' (PiP) - a pilot cluster randomised controlled trial of a physical activity intervention for children aged 18 months to 4 years old |
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Date of first enrolment:
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07/09/2012 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN54165860 |
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Study type:
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Interventional |
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Study design:
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Two-armed pilot cluster randomised controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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John
Wright |
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Address:
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Bradford Teaching Hospitals NHS Foundation Trust
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
BD9 6RJ
Bradford
United Kingdom |
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Telephone:
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+44 (0)1274 364 279 |
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Email:
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john.wright@bthft.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children aged 18 months to 4 years of age not in school
Exclusion criteria:
1. Children aged less than 18 months of age and those children aged 4 years and over
2. Enrolled into school
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Childhood obesity
Nutritional, Metabolic, Endocrine
Obesity
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Intervention(s)
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The intervention will include the introduction of organised and supported phyiscal activity sessions in playgrounds, followed by access to the playgrounds and play equipment unsupported up to 52 weeks from the start.
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Primary Outcome(s)
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1. Increased levels of physical activity in preschoolers
2. Improved wellbeing and self efficacy for adults attending the intervention with the preschoolers
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Secondary Outcome(s)
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1.Child health related quality of life (PedsQL) as well as anthropmetric measurements from the children
2. Parent health-related quality of life (EQ5D)
3. Self-efficacy (GSES)
4. Wellbeing (ComQol-A5)
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Source(s) of Monetary Support
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NIHR - Public Health Research Programme (UK)
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Ethics review
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Status:
Approval date:
Contact:
NRES Committee Yorkshire and The Humber, 30/07/2012 ref: 12/YH/0334
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2014 |
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URL:
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