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ISRCTN
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ISRCTN36363490
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of a nursery and home based intervention for obesity prevention and cardiovascular risk factor reduction
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Scientific title
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Acronym
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MAGIC (Movement and Activity Glasgow Intervention in Children)
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Serial number at source
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PG/2001/134
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Study hypothesis
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Cluster randomised controlled trial. 545 children in 36 clusters (nurseries). This study aims to test the hypothesis that a simple, generalisable, intervention can reduce change in body mass index (BMI) SD-score over a 12 month period in children in their pre-school year. The intervention is in two parts: enhanced physical activity programme in nursery; distribution of play resources/physical activity promotion at home.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Overweight, obesity, hypertension
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Participants - inclusion criteria
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Healthy 3 - 4 year-old children in their pre-school year in nursery.
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Participants - exclusion criteria
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No exclusion criteria
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Anticipated start date
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01/06/2002
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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545
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Interventions
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1. Intervention: nursery and home based physical activity programme
2. Control: standard nursery curriculum
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Primary outcome measure(s)
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BMI SD-score.
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Secondary outcome measure(s)
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1. Habitual physical activity and sedentary behaviour (both measured objectively, by accelerometry)
2. Motor skills (measured using the Movement Assessment Battery)
3. Blood pressure
4. Waist circumference and waist: arm circumference ratio (both indices of fat distribution)
5. Process evaluation
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Sources of funding
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British Heart Foundation (UK) (ref: PG/2001/134)
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Trial website
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15809570
2. http://www.ncbi.nlm.nih.gov/pubmed/17028105
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Contact name
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Dr
John J
Reilly
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Address
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Reader in Paediatric Energy Metabolism
University of Glasgow Division of Developmental Medicine
1st Floor Tower Block QMH
Yorkhill Hospitals
Dalnair Street
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City/town
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Glasgow
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Zip/Postcode
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G3 8SJ
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Country
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United Kingdom
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Tel
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+44 (0)141 201 0710
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Fax
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+44 (0)141 201 9275
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Email
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jjr2y@clinmed.gla.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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30/10/2001
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Last edited
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19/02/2008
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Date ISRCTN assigned
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30/10/2001
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