Lifestyle Intervention on Cardiovascular Risk: Comprehensive Peer Group-Based Trial

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Explore the impact of a comprehensive lifestyle intervention on cardiovascular risk through a peer group-based approach. This randomized controlled trial led by Valentin Fuster aims to assess the efficacy of modifying cardiovascular risk factors and behaviors through peer support strategies. The study involves a multicenter setup in various Spanish municipalities, emphasizing the potential benefits of peer group workshops and assessments in promoting healthy lifestyles.

  • Lifestyle Intervention
  • Cardiovascular Risk
  • Peer Support
  • Randomized Trial
  • Health Promotion
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  1. Impact of a Comprehensive Lifestyle Impact of a Comprehensive Lifestyle Peer Group Group- -Based Intervention on CV Risk Based Intervention on CV Risk Frs A Randomized Controlled Trial A Randomized Controlled Trial Peer Frs: : Valentin Fuster Valentin Fuster MD, PhD, on behalf of the on behalf of the Fifty Fifty- -Fifty Trial Investigators Fifty Trial Investigators MD, PhD, AHA Annual Scientific Sessions 2015 AHA Annual Scientific Sessions 2015 Embargoed Until 10:45 a.m. ET, Monday, Nov. 9, 2015

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

  3. Study Hypothesis Study Hypothesis Peer Support is a Proven Beneficial Strategy for Peer Support is a Proven Beneficial Strategy for Substance Abuse Substance Abuse Why not to Consider a Similar Peer Support Why not to Consider a Similar Peer Support Strategy to Modify CV Global Risk Frs. & Behavior ? Strategy to Modify CV Global Risk Frs. & Behavior ? Workshops Workshops Peer Peer Group Group Assessment Assessment Learning Learning process process

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

  5. Study Recruitment Study Recruitment Multicenter, Randomized, Controlled Multicenter, Randomized, Controlled Trial Trial Barcelona Barcelona N=86 N=86 Manresa Manresa N=96 N=96 Cambrils Cambrils N=69 N=69 N=648 Villanueva Villanueva N=96 N=96 San Fernando San Fernando N=104 N=104 Molina de Segura Molina de Segura N=127 N=127 Guadix Guadix N=70 N=70

  6. Selection of Selection of Participants Participants Inclusion criteria: Inclusion criteria: Age Age 25 25- -50 50 yrs yrs Overweight or Overweight or O Obesity: besity: BMI BMI 25 25 kg/m kg/m2 Physical Physical inactivity: inactivity: <150 exercise <150 exercise a a week week Smoker Smoker At baseline At baseline High High blood blood pressure: pressure: BP BP 140/90 mmHg or 140/90 mmHg or Rx Rx Exclusion criteria: Exclusion criteria: Pregnancy Pregnancy Chronic Disease Chronic Disease 2

  7. Baseline Baseline Characteristics Characteristics Control Control Group N=266 N=266 N N (%) (%) 189 (71) 189 (71) 17 (6) 17 (6) 78 (29) 78 (29) 171 (65) 171 (65) Group Intervention Intervention Group N=277 N=277 N N (%) (%) 198 (72) 198 (72) 5 (2) 5 (2) 58 (21) 58 (21) 214 (77) 214 (77) Group Women Women 25 25- -29 29 30 30- -39 39 40 40- -50 50 GENDER GENDER AGE AGE Hypertension Hypertension Overweight Overweight/ /Obese Smoking Smoking Physically Physically Inactive Low Low Medium Medium High High 47 (18) 47 (18) 218 (80) 218 (80) 82 (31) 82 (31) 220 (83) 220 (83) 13 (5) 13 (5) 115 (43) 115 (43) 138 (52) 138 (52) 8.3 8.3 (7.9 (7.9- -8.8) 60 (22) 60 (22) 235 (85) 235 (85) 85 (31) 85 (31) 221 (80) 221 (80) 15 (5) 15 (5) 146 (53) 146 (53) 116 (42) 116 (42) 8.4 (8 8.4 (8- -8.8) CV RISK FACTORS CV RISK FACTORS Obese Inactive EDUCATIONAL EDUCATIONAL LEVEL LEVEL 8.8) 8.8) FUSTER FUSTER BEWAT SC BEWAT SC

  8. Study Design Study Design FINAL FINAL SCREENING SCREENING BASELINE BASELINE ASSESSMENT ASSESSMENT INTERVENTION= 277 INTERVENTION= 277 FOLLOW FOLLOW- -UP ASSESSMENTS ASSESSMENTS UP WORKSHOPS WORKSHOPS CONTROL=266 CONTROL=266 648 648 1199 1199 INVITED INVITED 543 543 ELIGIBLE ELIGIBLE RANDOM. RANDOM. 16.2 16.2% RUN RUN- -IN % FAILED FAILED IN January 2016 September 2013 January 2015 January 2014

  9. The Intervention The Intervention 12 PEER GROUP MEETINGS Leaders Leaders Training Training 6 Workshps Leader Leader selection selection for for each each group group Small peer Small peer groups of 10 groups of 10 individuals) individuals) Intervention Intervention Group Participants Participants Group

  10. Outcome Measures 1 Outcome Measures 1 Fuster BEWAT Fuster BEWAT S Score: 0 core: 0- -3 3 Points Points Each Each Variable Variable . Blood Pressure . Exercise . Weight . Alimentation . Tobacco Primaryary Primaryary Outcome Secondary Secondary Outcome Components Components Of BEWAT Score Outcome: : Mean Outcome: : Mean Mean Change Change In BEWAT Score In BEWAT Score Mean Changes Changes In Individual In Individual Of BEWAT Score

  11. Outcome Measures 2 Outcome Measures 2

  12. Primary Outcome - ITT P=0.02 P=0.02 Fuster BEWAT Fuster BEWAT Score Score 9 9 8.84 P=0.88 8.8 8.8 8.6 8.6 8.41 8.4 8.4 8.34 8.2 8.2 8.17 8 8 7.8 7.8 baseline 1-year Control group Intervention group

  13. Secondary Secondary Outcome Outcome - - ITT ITT Tobacco component P=0.16 P=0.16 P=0.003 P=0.003 2.75 2.57 2.55 2.5 2.44 2.29 2.25 2 baseline 1-year Control group Intervention group

  14. High Vs. High Vs. Low (<7 (<7 Sessions Sessions vs 7 Low Adherence Adherence Mean Scores vs 7 Sessions Sessions) ) Mean Scores Waist Waist circumference circumference (cm) 1 (cm) 1 yr MVPA MVPA(min/ (min/day day) 1 ) 1 yr yr yr 35 102 101.6 30 P= 0.14 29.1 101 25 P= 0.08 100 19.7 20 99 15 98.3 98 10 5 97 0 96 low adherence low adherence high adherence high adherence low adherence low adherence high adherence high adherence

  15. Limitations Limitations Self Self- -Reported Outcomes, Objective Too Reported Outcomes, Objective Too Women 71%, Women 71%, Heterogeneus Heterogeneus Drop Drop- -out ITT ITT - - Multiple Imputation Analysis Multiple Imputation Analysis (Gender, Age, Municipality), (Gender, Age, Municipality), Only participants, 4/5 Risk Only participants, 4/5 Risk Frs out Rate Rate 16 16%, %, Frs p<0.05 p<0.05

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

  17. MEAN SCORES MEAN SCORES Screening / / Workshops Including Including Screening Workshops BEWAT OVERALL BEWAT OVERALL TOBACCO SCORE MEAN TOBACCO SCORE MEAN 9 3 Mean score in BEWAT OVERALL P=0.02 Mean score in tobacco 8.5 P=0.003 2.5 8 2 7.5 Screening Screening Baseline Baseline One year One year follow-up follow-up Screening Screening Baseline Baseline One year One year follow-up follow-up Intervention Intervention Control Control Total Participants Total Participants Intervention Intervention Control Control Total participants Total participants

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