1. Fast fOod Shops Significantly Impact Cardiovascular Karma - the FOSSICK IV Trial - Reddy M, Luque M, Ferrer Ferrer L, Koju R, Zaman MJ, Inspiron D, Caprnda M, Leosdottir M, Kengne AP. Circulation 2007;45:123-9 FOSS CK

2. Background Observational and case-control studies indicate a unfavorable CVD risk factor profile in individuals with high fast-food consumption compared to the general population (1,2) No randomized trial has yet been conducted to evaluate the relationship between fast-food exposure and cardiovascular disease or CVD risk factors. 1.Kengne AP et al. FOSSICK I Study. Lancet 2003 2.Leong T et al. FACE-IT Study. NEJM 2006 FOSS CK

3. Background Previous studies have shown a strong relationship between cholesterol and blood pressure levels and CVD risk Lowering LDL cholesterol by 40 mg/dl decreases CHD mortality by 20% and stroke mortality by 17%. FOSS CK

4. Study question Is decreased use of fast food shops associated with improved cardiovascular risk profile? FOSS CK Fast food  LDL  CVD risk

5. Design Randomized clinical trial Single-blinded –Subjects not blinded –Investigators not blinded –Analysers blinded Intention-to-treat analysis FOSS CK

6. Exposure Use of fast food shops to purchase a meal Definitions: –Use: Consumption of a meal (breakfast, lunch or dinner) –Fast food shops: Listed for the subjects (McDonalds, KFC, TacoBell etc....) FOSS CK

7. Standard deviation Minimum detectable alternative Number of subjects needed LDL cholesterol 15 mg/dl [0.40 mmol/l] 10 mg/dl [0.25 mmol/l] 55 + 55 Total cholesterol 25 mg/dl [0.60 mmol/l] 10 mg/dl [0.25 mmol/l] 122 + 122 α = 5%, β = 10%, power 90% Sample size determination FOSS CK

8. Chicago Sear’s Tower (n=10 000) Subjects expressing interest in participation (n=1 300) Informed consent & baseline screening (n=510) 30 subjects excluded after lipid/glucose analysis FOSS CK RANDOMIZATION Exclusion / not interested (n=790) Study design & protocol I

9. Control group (n=240) Unchanged dietary pattern Intervention group (n=240) Elimination of use of fast food shops Study design & protocol II FOSS CK RANDOMIZATION Follow up: 3 months Final study visit

10. Baseline examination Questionnaires: –Baseline information plus physical activity – Fast food consumption –Food Frequency Questionnaire Physical examination Blood sampling FOSS CK

12. Intervention Information at baseline –Small group info meetings Support: –Telephone calls / interviews / counselling –SMS text messages –Newsletters Measurements of compliance FOSS CK

13. Outcomes Change in: –LDL (primary outcome) –Total cholesterol –TG –HDL –FPG –Blood pressure –BMI –WHR/waist circumference FOSS CK

14. Control groupIntervention group n=235n=232 Age (years)39.3 ± 7.239.4 ± 7.1 % females47%45% % caucasian73%71% Mean ys of education8.3 ys8.1 ys % smokers23%20% Income (US$ pr year)45 354 US$45 289 US$ Average PA (mean score 1-4)2.42.6 Mean energy intake (kcal/day)25562487 Weekly use of FF shops5.55.6 Mean alcohol intake (g/day)14.216.3 Mean LDL (mmol/l)3.73.8 BMI25.124.9 Selected baseline characteristics FOSS CK

15. Results presentation Control group Interven tion group Sign. TC LDL HDL TG FPG SBP DBP BMI WHR Waist c. FOSS CK

16. Budget SOURCES OF $$$: 1.NHLBI 2.FOOD INDUSTRY (healthy fast food shops, grocery stores) 3.FOUNDATIONS (e.g. Fogarty Foundation, Wellcome Trust) PROJECTED BUDGET: $3 MILLION FOSS CK

17. Discussion Study strengths –First study of its kind –Generalisability Possible limitations of the study –Effect of the chosen method of intervention –Measurement of the exposure/compliance FOSS CK

18. Thank you!! FOSS CK

19. References Dariush M et al. Trans Fatty Acids and Cardiovascular Disease. N Engl J Med 2006; 354: 1601-1613. AFCAPS/TexCAPS Research Group. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA 1998; 279: 1615-1622. National Cholesterol Education Program: National Heart, Lung, and Blood Institute National Institutes of Health NIH Publication No. 02-5215 September 2002 FOSS CK