title: Effectiveness of the Kids in Control of Food (KICk-OFF) structured education course for 11-16 year olds with Type 1 diabetes.
abstract: OBJECTIVE
  To assess the effect of a 5-day structured education course (Kids in Control of Food; KICk-OFF) on biomedical and psychological outcomes in young people with Type 1 diabetes.
  
  
  METHODS
  This was a cluster-randomized trial involving 31 UK paediatric centres. Participants were recruited prior to stratified centre randomization. Intervention centres delivered KICk-OFF courses, whereas control centres delivered usual care. Participants were 11-16 years of age and had Type 1 diabetes for at least one year. The KICk-OFF course was delivered by trained educators to eight participants per course. Glycaemic control and quality of life were measured at baseline, 6, 12 and 24 months. Secondary outcomes were hypoglycaemia, ketoacidosis, fear of hypoglycaemia and diabetes self-efficacy.
  
  
  RESULTS
  Three hundred and ninety-six participants provided baseline data (199 intervention and 197 control). At 6 and 12 months the intervention group showed significantly improved total generic quality of life scores compared with controls (baseline: 80 vs. 82; 6 months: 82 vs. 82; P = 0.04). Across the whole intervention group mean HbA1c levels were not significantly different from controls; baseline HbA1c mean (95% confidence interval), 78 mmol/mol (75-81) vs. 76 mmol/mol (74-79) [9.3% (9-9.6%) vs. 9.1% (8.9-9.4%); 24 months: 77 mmol/mol (74-79) vs. 78 mmol/mol (75-81) (9.2% (8.9-9.4%) vs. 9.3% (9-9.6%)], adjusted mean difference, -2.0 mmol/mol (6.5-2.5) [2.3% (-2.7% to 2.4%)], P = 0.38.
  
  
  CONCLUSIONS
  Attending a KICk-OFF course was associated with significantly improved total quality of life scores within 6 months. Glycaemic control, as measured by HbA1c , was no different at 24 months. (Clinical Trial Registry No: ISRCTN3704268).
authors.affiliation: Sheffield Children's Hospital, Sheffield, UK.
authors.forename: K J
authors.initials: KJ
authors.lastname: Price
authors.affiliation: Sheffield Children's Hospital, Sheffield, UK.
authors.forename: J A
authors.initials: JA
authors.lastname: Knowles
authors.affiliation: Sheffield Children's Hospital, Sheffield, UK.
authors.forename: M
authors.initials: M
authors.lastname: Fox
authors.affiliation: Department of Child Health, University of Sheffield, Sheffield Children's Hospital, Sheffield, UK.
authors.forename: J K H
authors.initials: JK
authors.lastname: Wales
authors.affiliation: Department of Human Metabolism, University of Sheffield, Sheffield, UK.
authors.forename: S
authors.initials: S
authors.lastname: Heller
authors.affiliation: Department of Psychology, University of Sheffield, Sheffield, UK.
authors.forename: C
authors.initials: C
authors.lastname: Eiser
authors.affiliation: Division of Epidemiology and Biostatistics, University of Leeds, Leeds, UK.
authors.forename: J V
authors.initials: JV
authors.lastname: Freeman
mesh_terms: D000293:Adolescent; D017195:Adolescent Nutritional Physiological Phenomena; D002648:Child; D002664:Child Nutritional Physiological Phenomena; D016000:Cluster Analysis; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000523:psychology / Q000628:therapy*; D003927:Diet, Diabetic; D000066498:Emotional Adjustment; D005260:Female; D005500:Follow-Up Studies; D006126:Group Processes; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000517:prevention & control; D008297:Male; D010349:Patient Compliance; D010353:Patient Education as Topic; D011788:Quality of Life; D013315:Stress, Psychological / Q000150:complications / Q000209:etiology / Q000517:prevention & control*; D006113:United Kingdom