Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kick-off.org.uk

Contact information

Type

Scientific

Primary contact

Mr Martin Fox

ORCID ID

Contact details

Clinical Research Facility
D Floor
Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom
-
Martin.Fox@sch.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5015

Study information

Scientific title

A multicentre, randomised controlled trial comparing intensive structured education with standard education in 11 - 16 year olds on intensive insulin therapy

Acronym

DRN191 KICk-OFF

Study hypothesis

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

North Sheffield Local Research Ethics Committee, 18/09/2008, ref: 08/H1308/201

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 576; UK sample size: 576

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

31/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Sheffield Children's NHS Foundation Trust (UK)

Sponsor details

Western Bank
Sheffield
S10 2TH
United Kingdom
-
crf@sch.nhs.uk

Sponsor type

Government

Website

http://www.sheffieldchildrenscrf.nhs.uk

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23355675

Publication citations

Additional files

Editorial Notes