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Valentin Fuster MD, PhD, on behalf of the Fifty-Fifty Trial Investigators

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. Background.

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Valentin Fuster MD, PhD, on behalf of the Fifty-Fifty Trial Investigators

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

  2. Steering Committee

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

  4. Study Hypothesis 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. - Training workshops Peer group dynamics Assessment Learningprocess

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

  6. Study Design SCREENING BASELINE FINAL ASSESSMENT INTERVENTION= 277 FOLLOW-UP ASSESSMENTS WORKSHOPS CONTROL=266 1199INVITED 648 ELIGIBLE 543 RANDOM. 16.2% FAILED RUN-IN January 2015 January 2014 September 2013

  7. Selection of participants Inclusion criteria: Age 25-50 yrsboth inclusive • Overweight or Obesity:BMI ≥ 25 kg/m2 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

  8. The Intervention 12 PEER GROUP meetings Intervention Group Participants Monthly Meetings  60 – 90 Min.

  9. Outcome Measures

  10. Outcome Measures Fuster BEWAT Score: 0-3 PointsEach Variable . BloodPressure . Exercise . Weight . Alimentation . Tobacco PrimaryaryOutcome: Mean Change In BEWAT Score SecondaryOutcome: Mean Changes In Individual Components Of BEWAT Score

  11. BaselineCharacteristics

  12. PrimaryOutcome - ITT

  13. SecondaryOutcome - ITT P=0.003

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

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

  16. Conclusions • 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.

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