Kids In Control OF Food (KICk-OFF)

Phase 3

Completed

• Conditions: Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: Diabetic Control, Education, Insulin Initiation, Nutrition, Paediatric, Service delivery; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN37042683
• Lead Sponsor: Sheffield Children's NHS Foundation Trust (UK)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23355675 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26248789 2016 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/27719689

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-07
• Study Completion: 2012-08-31
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 576

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c %, measured at baseline, 6 months, 12 months and 24 months

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline, 6 months, 12 months and 24 months:<br> 1. Change in psychological outcome in parents and children<br> 2. Changes in weight, height and body mass index (BMI)<br> 3. Diet related behaviours<br> 4. Health economic analysis<br> 5. Health economic modelling of long term cost/benefits<br> 6. Change in the number and severity of hypoglycaemic episodes<br>