Impact of a Comprehensive Lifestyle Peer Group- Based Intervention on CV Risk Factors: A Randomized Controlled Trial Valentin Fuster MD, PhD, on behalf of the Fifty-Fifty Trial Investigators American Heart Association Annual Scientific Sessions 2015

Steering Committee VALENTIN FUSTER, MD, PHD – PI AND STUDY CHAIRMAN EMILIA GOMEZ, PhD - CO PI, RAMONA MARTINEZ, MSc VANESA CARRAL, PhD CARLA RODRIGUEZ, BA SHE FOUNDATION, SPAIN JUAN M. FERNANDEZ ALVIRA, PhDCNIC, MADRID, SPAIN RAJESH VEDANTHAN, MD, MPH SAMEER BANSILAL, MD, MS ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, USA TERESA ROBLEDO, MD Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN), SPAIN IÑAKI MARINA, MD Catalan Health Institute, Spain

Background Community-based Program In 7 Municipalities (Spain) Grenada Island Cardona ( Barcelona )

Training workshops Assessment Peer group dynamics Study Hypothesis Learning process When adults are trained among peers, and are provided with new knowledge, skills and attitudes regarding healthy lifestyle, their cardiovascular health and self- control of risk factors will improve. -

Barcelona N=86 Cambrils N=69 San Fernando N=104 Molina de Segura N=127 Guadix N=70 Manresa N=96 N=648 Study Recruitment Villanueva N=96 Multicenter, Randomized, Controlled, Peer Group-based Intervention

1199 INVITED 543 RANDOM. WORKSHOPS INTERVENTION= 277 CONTROL= ELIGIBLE 16.2% FAILED RUN-IN SCREENING BASELINE FINAL ASSESSMENT FOLLOW-UP ASSESSMENTS January 2014 January 2015 September 2013 Study Design

Selection of participants Inclusion criteria: Age yrs both inclusive Overweight or Obesity: BMI ≥ 25 kg/m 2 or Physical inactivity: carry out less than 150 minutes of exercise a week or Smoker or High blood pressure: BP≥140/90 mmHg or Rx Exclusion criteria:. Pregnancy. Chronic D. - Liver / Renal

Intervention Group Participants The Intervention

Outcome Measures

Fuster BEWAT Score: 0-3 Points Each Variable. Blood Pressure. Exercise. Weight. Alimentation. Tobacco Primaryary Outcome: Mean Change In BEWAT Score Secondary Outcome: Mean Changes In Individual Components Of BEWAT Score Outcome Measures

Control Group N=266 Intervention Group N=277 N (%) GENDER Women 189 (71)198 (72) AGE (6)5 (2) (29)58 (21) (65)214 (77) CV RISK FACTORS Hypertension 47 (18)60 (22) Overweight/Obese 218 (80)235 (85) Smoking 82 (31)85 (31) Physically Inactive 220 (83)221 (80) EDUCATIONAL LEVEL Low 13 (5)15 (5) Medium 115 (43)146 (53) High 138 (52)116 (42) FUSTER BEWAT SC 8.3 ( )8.4 (8-8.8) Baseline Characteristics

Primary Outcome - ITT

Secondary Outcome - ITT P=0.003

High Vs. Low Adherence Mean Scores (<7 Sessions vs ≥7 Sessions) P= 0.14 P= 0.08

Limitations Self –Reported Outcomes Missing Data: 16% Drop-out Rate. Evaluated Through Multiple Imputation And Bounds Analysis- Consistent Results.

The Fifty-Fifty peer group-based lifestyle management program had a positive impact on the participants showing an overall improvement of the BEWAT score and its behavioral components, especially smoking cessation. Wider adoption of such a program may have a meaningful impact on CV health promotion. A follow-up assessment will be performed one year after the final results reported here to determine long-term sustainability of the improvements. Conclusions