1. III International Scientific Congress of Maritime, Tropical, Hyperbaric and Travel Medicine Copenhagen / Oslo, 20-24 May 2015 on-board the DFDS SEAWAYS ferry. Organisers: Polish Society of Maritime, Tropical and Travel Medicine Institute of Maritime and Tropical Medicine – Medical University of Gdansk National Centres for Maritime, Tropical and Hyperbaric Medicine in Gdynia International Maritime Health Association Events’ motto: Healthcare upon the sea and in the travel The IDEAL Intervention study model of the Non- Communicable Diseases –A challenge Olaf Jensen, Centre for Maritime Health and Society, Esbjerg, Denmark

2. Background The World Health Organization reports the Non- Communicable Diseases to be by far the leading cause of death in the world, representing over 60% of all deaths. Risk factors such as a person's physical activities and the type and amount of food are known to be the major preventable risk factors.

3. Natural History of Obesity Leading to Type 2 Diabetes Genetic susceptibility Environmental factors Nutrition Physical inactivity Atherosclerosis Hyperglycemia Hypertension Retinopathy Nephropathy Neuropathy Blindness Renal failure CHD Amputation Onset of diabetes Complications Disability Death Ongoing hyperglycemia IGT Obesity Insulin resistance Risk for Disease Metabolic Syndrome

4. Tendencias Obesidad Entre Adultos EEUU (BMI ≥ 30)

5. Intervention research – success? Intervention studies to prevent the Non- Communicable Diseases have been increasingly used in many countries. The methods are most often counselling or education to modify the specific risk factors for overweight, cardiovascular diseases, diabetes and hypertension,

6. Intervention research – success? The objective here is to present the methodological gold standard for the intervention studies and to discuss how to improve the intervention studies and the prevention of this global epidemy

7. Goal of intervention research The primary goal of intervention research is to try out in a sample whether some particular learning could or should be implemented in a larger scale to improve health.

8. 1.Incidence/prevalence (of health and exposures) Cross sectional or cohort 2. 2. Causal analysis Cohort or case-referent 3. 3. Intervention - prognostic Cohort (before and after randomized) Full-scale implementation Triad of Epidemiology

9. Objective _ example To reduce the number of seafarers unable to pass the health examination caused by high BMI from 10% to 5% in 3 years.

10. Study design, example Randomized cohort of seafarers aged 20-40 years from long distance cargo ships Development of program Implementation of program Epidemiological Impact evaluation Qualitative evaluation of learning and change objectives Evaluation of sustainability and full scale implementation

11. 1. Define the cohort to be used for the intervention

12. 2. Randomize the cohort in 2 groups Randomized Inter- vention Persons =104 Reference Group Persons= 98

13. 3. Define time shedule Randomized Inter- vention Persons =104 Reference Group Persons= 98

14. 3. Define time shedule Randomized T0T1 Inter- vention Persons =104 Reference Group Persons= 98 1 year

15. 3. Define time shedule Randomized T0T1T2 Inter- vention Persons =104 Reference Group Persons= 98 1 year

16. 3. Define time shedule Randomized T0T1T2T3 Inter- vention Persons =104 Reference Group Persons= 98 1 year

17. 4. Define intervention period Randomized T0T1T2T3 Inter- vention Persons =104 Reference Group Persons= 98 1 year

18. 5. Define type of intervention Randomized T0T1T2T3 Inter- vention Persons =104 Reference Group Persons= 98 1 year

19. 6. Measure incidence rates T0-T1 before intervention Randomized T0T1T2T3 Inter- vention Persons =104 Reference Group Persons= 98 1 year

20. 6. Measure incidence rates T0-T1 before intervention Randomized T0T1T2T3 Inter- vention Persons =104 * * * * * * Reference Group Persons= 98 1 year

21. 6. Measure incidence rates T0-T1 before intervention Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 Inter- vention Persons =104 * * * * * *125 Reference Group Persons= 98 * * * * 1 year

22. 6. Measure incidence rates T0-T1 before intervention Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 Inter- vention Persons =104 * * * * * *125 Reference Group Persons= 98 * * * * 122 1 year

23. 7. Perform the intervention T1-T2 Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 Inter- vention Persons =104 * * * * * *125 Reference Group Persons= 98 * * * * 122 1 year

24. 7. Perform the intervention T1-T2 Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 Inter- vention Persons =104 * * * * * *125 Reference Group Persons= 98 * * * * 122 1 year

25. 8. Measure incidence rates T1-T2 during intervention Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 Inter- vention Persons =104 * * * * * *125 Reference Group Persons= 98 * * * * 122 1 year

26. 8. Measure incidence rates T1-T2 during intervention Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 B T1-T2 Inter- vention Persons =104 * * * * * * * ** * * * *12567 Reference Group Persons= 98 * * * * * * * * 122102 1 year

27. 9. Measure incidence rates T2-T3 after intervention Rates per 1000 persons per year Randomized T0T1T2T3 A T0-T1 B T1-T2 C T2-T3 Inter- vention Persons =104 * * * * * * * ** * * * * * ** * * * * 1256777 Reference Group Persons= 98 * * * * * * * * * * ** * 12210292 1 year

28. 10. Calculate Relative Risks T1/T3 after/before intervention Rates per 1000 persons per year RR Randomized T0T1T2T3 A T0-T1 B T1-T2 C T2-T3 C/A Inter- vention Persons =104 * * * * * * * ** * * * * * ** * * * * 12567770.62 Reference Group Persons= 98 * * * * * * * * * * ** * 122102920.75 1 year

29. 11. Relative Risks of Intervention and reference groups Rates per 1000 persons per year RR Randomized T0T1T2T3 A T0-T1 B T1-T2 C T2-T3 C/A Inter- vention Persons =104 * * * * * * * ** * * * * * ** * * * * 12567770.62 Reference Group Persons= 98 * * * * * * * * * * ** * 122102920.75 1 year RR 1.00.650.83

30. Conclusion of the theoretical example Let´s say there was no significant effect of the intervention Should a large scale program be implemented ? Why ?

31. Worksite Nutrition and Physical Activity Interventions - review … found that worksite nutrition and physical activity programs achieve modest improvements in employee weight status at the 6–12-month follow-up. Anderson LM, Quinn TA, Glanz K, Ramirez G, Kahwati LC, Johnson DB, et al. The effectiveness of worksite nutrition and physical activity interventions for controlling employee overweight and obesity: a systematic review. Am J Prev Med. 2009 Oct;37(4):340–57.

32. The ’Healthy Heart Programmes’ Cochrane review Multiple risk factor interventions in 57 studies had little or no impact on the risk of coronary heart disease mortality or morbidity The effects of attempting behaviour change in the general population are limited and do not appear to be effective. Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database of Systematic Reviews. Issue 1, 2011, Issue 2, 2013

33. Lancet Series 1 ”The global obesity pandemic: shaped by global drivers and local environments” The increases in obesity in almost all countries seem to be driven mainly by changes in the global food system. Unlike other major causes of preventable death and disability, such as tobacco use, there are no exemplar populations in which the obesity epidemic has been reversed by public health measures. Swinburn BA, Sacks G, Hall KD, McPherson K, Finegood DT, Moodie ML, et al. The global obesity pandemic: shaped by global drivers and local environments. Lancet. 2011 Aug 27;378(9793):804–14.

34. 34 1950 - multifactural causal model  multifatural prevention

35. 35 1980 -> limited causal model  limited or no prevention

36. 36 1980 -> limited – individual causal model  limited effect documented

37. 37 2014 -> a comprehensive model

40. ILO: Integrating health promotion into workplace Integrating health promotion into workplace OSH policies Stress Violence, Smoke-free workplaces Alcohol and drugs, Nutrition, Physical activity, Healthy sleep HIV/AIDS.

41. WHO: Definition of health Good health is a state of complete physical, social and mental well-being, and not merely the absence of disease or infirmity. Good health is a fundamental human right - Universal Declaration of Human Rights (1948).

42. Conclusions Health promotion intervention studies are so far likely to have only small impact on mortality and morbidity Despite these facts: health promotion intervention research is still needed to persue the other part of the WHO goals: physical, mental and social well-being. This may on the long run, reduce the mortality and morbidity – time will show

43. To reduce mortality and morbidity, concerted actions with comprehensive structural programs by the national governments, civil communities, educators, employers, unions etc are needed In the maritime area, interventions should be wider than on board the ships – the maritime industry may go together with the national and international (ILO-WHO) public and occupational health programs

44. Issues for discussion 1) How can effective maritime health intervention studies be designed? 2) How can the seafarer´s health examinations be used for systematic health intervention programs? 3) A challenge for the global maritime industry with the IMHA-Research joining the public health programs

45. Thank you very much