Kids In Control OF Food (KICk-OFF)

ISRCTN	ISRCTN37042683
DOI	https://doi.org/10.1186/ISRCTN37042683
Secondary identifying numbers	5015

Submission date: 07/07/2010
Registration date: 07/07/2010
Last edited: 14/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Martin Fox
Scientific

Clinical Research Facility, D Floor
Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom

Email	Martin.Fox@sch.nhs.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre, randomised controlled trial comparing intensive structured education with standard education in 11 - 16 year olds on intensive insulin therapy
Study acronym	DRN191 KICk-OFF
Study objectives	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. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5015
Ethics approval(s)	North Sheffield Local Research Ethics Committee, 18/09/2008, ref: 08/H1308/201
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: Diabetic Control, Education, Insulin Initiation, Nutrition, Paediatric, Service delivery
Intervention	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
Intervention type	Other
Primary outcome measure	Change in HbA1c %, measured at baseline, 6 months, 12 months and 24 months
Secondary outcome measures	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
Overall study start date	01/09/2008
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	11 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	Planned sample size: 576; UK sample size: 576
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/09/2008
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sheffield Children's Hospital

Sheffield
S10 2TH
United Kingdom

Sponsor information

Sheffield Children's NHS Foundation Trust (UK)
Hospital/treatment centre

Western Bank
Sheffield
S10 2TH
England
United Kingdom

Email	crf@sch.nhs.uk
Website	http://www.sheffieldchildrenscrf.nhs.uk
"ROR"	https://ror.org/02md8hv62

Funders

Funder type

Charity

Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	24/01/2013	Yes	No
Results article	cost-effectiveness results	01/01/2016	Yes	No
Results article	results	01/02/2016	Yes	No

Editorial Notes

14/11/2018: Publication references added.