1. Kids In Control OF Food Dr Katherine Price Sheffield Children’s Hospital

2. The KICk-OFF Journey Background Development Pilot KICk-OFF RCT

3. WHO DEALS WITH DIABETES? Peter Hindmarsh Patient School Health Care Professional Clinic Setting Hours spent with diabetes over 3 months 2160 480 12 0.25 - 0.50

4. Background DAFNE study group Good outcomes in diabetes control and quality of life from cross over study in adults British Medical Journal 2002;325(7367):746. 2001 – Diabetes UK met with several UK paediatric centres Sheffield given task of taking forward paediatric DAFNE

5. Medical Research Council – A framework for development and evaluation of RCTs for complex interventions to improve health ( www.mrc.ac.uk April 2000, updated 2008) 4 phase approach 1.Theoretical “ Modelling” phase 2.Development phase 3.Pilot evaluation 4.Randomised controlled trial Research question: What is the effect of an intensive, structured education course on glycaemic control and quality of life in children with Type 1 diabetes?

6. DAFNE is based on model of therapeutic patient education developed in Germany ( Dusseldorf model) DAFNE trial in UK demonstrated benefit in 150 adults – improved blood sugar control, improved quality of life, less hypos Social learning theory – Bandura Phase 1 – theoretical modelling

7. Social Learning Theory – A. Bandura 1977 People learn from one another via: observation of behaviour and attitudes imitation and adaptation Requires : attention – affected by complexity, functional value retention – affected by imagery, organisation reproduction - physical capability, self observation motivation - reinforced by past and promised incentives

8. Phase 2 – development Aim: to produce an education course for children with type 1 diabetes, that - was age appropriate - was acceptable to children and families - used recognised educational techniques  Julie Knowles - Research nurse, Helen Waller - Psychologist  PDSN survey (Autumn 2002) Journal Of Diabetes Nursing 2005;9:332-339.  Focus groups (Jan. 2003) Child: Care, Health and Development 2005;31(3):283-289.  Lubeck, Germany (Jan. 2004)

9. How do we develop and implement educational interventions? Understand how children learn Educational Theories Understand how to teach Learning styles Develop a curriculum

10. How do you learn?

11. Principles of Adult Learning Adults are autonomous and self-directed Adults have a wealth of life experiences and knowledge Adults are goal orientated Adults are relevancy orientated Adults are practical Adults demand respect from instructors The adult learner a neglected species. Malcolm Knowles 1994

12. How do children learn? “ Theories Behaviourism Learning from external stimuli. It can be conditioned by giving rewards and punishments Piaget – 4 stages of child development. Focused on maturation. Growing up does not mean knowing more but it changes how we think. Vygotsky – Learning is a social process Language development and learning through interaction with others of same age and older. IQ – Focused on the concept of a general intelligence Gardener – “multiple intelligences” allowing different learning styles Muijs et al (2005). Effective Teaching

13. Working with teachers and educationalists Presentation Reading age Lesson planning Specific teaching skills Style of teaching (observation) Setting boundaries/learning environment King Edward V11 Secondary School

14. Lesson planning A step by step guide to the education session to allow replication by others and achievement of goals Office For Standards in Education (OFSTED) Is it clear what the purpose of the lesson is? Has the lesson taken into account the learners needs?

15. 5 day out patient course for 11-16 yr olds 8 per group Age banded 11-13 years and 14-16 years Modular structure, Involves parents and friends Variety of teaching styles – very practical and interactive KICk-OFF course

16. Transition of care Living with diabetes School and Diabetes Hypoglycaemia Monitoring Insulin management Sick day rules What is diabetes? Food and diabetes Modules from the Paediatric KICk-OFF Curriculum

17. Tuesday Learning objectives  Individual insulin adjustment practice  Continue with carbohydrate and insulin ratios  Further skills in counting grams of carbohydrate  Hypoglycaemia – signs and symptoms, treatment and prevention  Feedback to carers  Continue with school packs Today’s programme Session 1 9.00am-10.30am Discussion about individual blood glucose levels Hypoglycaemia BREAK Session 2 10.45am-12.15pm Hypoglycaemia CP/insulin ratio Work out CP’s for lunch PACKED LUNCH Session 3 1.00pm-2.15pm Practical session [cooking] on counting grams of carbohydrate BREAK Session 4 2.30pm-4.00pm Prepare food for parents to practice CHO estimation Quiz Parents invited to listen. Recap days objectives Plan evening insulin dose KICk-OFF curriculum – day 2

18. EducatorDietitian and nurse Preparation Transport children to school cookery room. Set up the work stations with foods needed for recipes. TIM E EDUCATOR ACTIVITY STUDENT ACTIVITY MATERIALS 2pm Explain:- This session is a practical session to learn how to work out how much CHO is in the food you prepare. Group to split into pairs and they are each given a recipe Response:  Split into pairs but not the same pairs as the morning  Follow recipes  Tidy up after the food is prepared  Complete work sheet 4 recipes for fruit muffins fruit scones jam and butter scales Paper plates ingredients utensils Calculators Pens Flip charts Worksheet for estimating CP’s in rice, pasta, potato, cereals.

19. Day 2, session 4. Counting grams of carbohydrate TUESDAY Session 4:-  Counting grams of carbohydrate  Practical session Learning Objectives  Continue with carbohydrate and insulin ratios  Continuing with learning the skills for counting grams of carbohydrate Materials  Scales  Food ingredients  Recipes  Flip chart  Pens  Diaries  Work sheets  Calculators  Plates  Kitchen equipment  Digital scales  Pots and pans  Baking tins  Washing up materials  (tea towels, cloths, washing up liquid)

20. Chocolate Chip Muffins Ingredients 150g/5oz self-raising flour 150g/5oz margarine 150g/5oz sugar 2 eggs 75g/3oz chocolate chips 100g/3½oz drinking chocolate powder Session 4 2.30pm-4.00pm Prepare food for parents to practice CHO estimation Quiz Carbohydrate counting in snacks and recipes

21. Outcomes over 6 months Educational evaluation Process evaluation Interviews with psychologist Biomedical – HbA1c, Hypos, BMI Psychological – quality of life, self efficacy, family conflict etc Results Good evaluation – some changes to programme More parent teaching HbA1c – unchanged overall Improved in those with poor control Improved in younger age group QOL – improved Self efficacy, coping with diabetes etc improved Phase 3 –Pilot evaluation December 2003 - 2004 : 6 courses – 48 young people, age 11-16 yrs from 3 centres

22. Hands on Learning … Social Support…

23. Cooking and Counting Carbs … Eating Out and Bowling Exercising in the Gym

24. Improve presentation : Cell energy

25. Phase 4 – randomised controlled trial In 11-16 year olds on intensive insulin therapy : - Does the KICk-OFF structured education course affect outcomes, measured over 2 years? Primary outcome measures: Biomedical – blood sugar control (HbA1c), hypoglycaemia Psychological – quality of life, fear of hypoglycaemia, self efficacy Secondary outcomes Process evaluation, sustainability of education Weight, diet Is it cost effective ? Website support

26. Educator training and support How do we ensure uniformity of teaching in all centres? Does the curriculum allow key learning points to be achieved? Can there be flexibility within a curriculum? How do we support the learning needs of educators? 5 day Educator Training course – Sheffield Hallam University Quality assurance/ peer review

27. Trial Design Risk of “ contamination of control group in clinic trained to deliver the course – cluster randomisation The intervention will be delivered to groups rather than individuals Variation between centres –in HbA1c, staffing levels, ethnic & social mix of patients, current educational practise – stratification

28. Each recruit 16-32 N=560 n= 280 15 Control15 Intervention 30 centres Centre stratification KICk-OFF courses Usual care Follow up 6,12 & 24 months KICk-OFF courses 5 days 3 educators (2 research staff, 1 local) 8 participants 11-13 or 14-16 yrs

29. 4 year project from Sept 08 Martin Fox – project coordinator Julie Knowles- lead educator Project group – Educationalists - Jerry Wellington, Grace Hoskins 1 Health Economics – Alan Brennan, Katherine Stephens 1 Psychology – Chris Eiser 1 Clinical – Simon Heller, Jerry Wales 1 Statistician – Jenny Freeman 1 Website development and evaluation – Amy McPherson 2 1 = University of Sheffield, 2 = University of Nottingham

30. Current priorities local R&D/ ethics approval and centre stratification recruitment of participants then centre randomisation 6 educator posts start Sept 09 educational material – printing, purchase etc website – to support learning of those in KICk-OFF groups www.kick-off.org.uk

31. Thank you : Diabetes UK Julie Knowles and all the research team To all the centres participating Children and families for their support