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

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 Leong T et al. FACE-IT Study. NEJM 2006 FOSS CK

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

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

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

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

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] Total cholesterol 25 mg/dl [0.60 mmol/l] 10 mg/dl [0.25 mmol/l] α = 5%, β = 10%, power 90% Sample size determination FOSS CK

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

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

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

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

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

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

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

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

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

Thank you!! FOSS CK

References Dariush M et al. Trans Fatty Acids and Cardiovascular Disease. N Engl J Med 2006; 354: 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: National Cholesterol Education Program: National Heart, Lung, and Blood Institute National Institutes of Health NIH Publication No September 2002 FOSS CK