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ISRCTN
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ISRCTN37042683
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ClinicalTrials.gov identifier
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Public title
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Kids In Control OF Food (KICk-OFF)
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Scientific title
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A multicentre, randomised controlled trial comparing intensive structured education with standard education in 11 - 16 year olds on intensive insulin therapy
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Acronym
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DRN191 KICk-OFF
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Serial number at source
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5015
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Study hypothesis
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Kids In Control OF Food: a multi-centre, cluster randomised controlled trial comparing structured education (the KICk-OFF course) with standard care in 11 - 16 year olds with type 1 Diabetes (T1DM) on intensive insulin therapy.
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Lay summary
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Ethics approval
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North Sheffield Local Research Ethics Committee approved on the 18th September 2008(ref: 08/H1308/201)
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Study design
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Multicentre randomised interventional treatment 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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Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: Diabetic Control, Education, Insulin Initiation, Nutrition, Paediatric, Service delivery
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Participants - inclusion criteria
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1. T1DM of at least 1 year's duration
2. Already on or willing to use multiple dose insulin (MDI)
3. Aged 11 - 16 years (in Secondary School years 7 - 12), either sex
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Participants - exclusion criteria
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1. Factors which will impair group participation
2. Non-English speaking
3. Learning disability - additional help in school
4. Major behavioural problems
5. Evidence of an eating disorder
6. Associated illness that may influence control
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Anticipated start date
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01/09/2008
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Anticipated end date
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31/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 576; UK sample size: 576
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Interventions
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Intervention: 5 day, outpatient, skills training course, designed and piloted specifically for this age group
Control: Standard care
Treatment and follow-up duration: 24 months in both arms
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Primary outcome measure(s)
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Change in HbA1c %, measured at baseline, 6 months, 12 months and 24 months
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Secondary outcome measure(s)
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Measured at baseline, 6 months, 12 months and 24 months:
1. Change in psychological outcome in parents and children
2. Changes in weight, height and body mass index (BMI)
3. Diet related behaviours
4. Health economic analysis
5. Health economic modelling of long term cost/benefits
6. Change in the number and severity of hypoglycaemic episodes
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Sources of funding
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Diabetes UK (UK)
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Trial website
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http://www.kick-off.org.uk
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Publications
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Contact name
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Mr
Martin
Fox
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Address
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Clinical Research Facility, D Floor
Stephenson Wing
Western Bank
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City/town
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Sheffield
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Zip/Postcode
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S10 2TH
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Country
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United Kingdom
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Email
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Martin.Fox@sch.nhs.uk
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Sponsor
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Sheffield Children's NHS Foundation Trust (UK)
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Address
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Western Bank
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City/town
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Sheffield
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Zip/Postcode
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S10 2TH
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Country
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United Kingdom
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Email
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crf@sch.nhs.uk
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Sponsor website:
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http://www.sheffieldchildrenscrf.nhs.uk
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Date applied
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07/07/2010
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Last edited
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26/07/2010
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Date ISRCTN assigned
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07/07/2010
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