Jennifer K Coffeng1, Hidde P van der Ploeg2, José M Castellano3, Juan M Fernández-Alvira4, Borja Ibáñez5, Inés García-Lunar6, Allard J van der Beek2, Antonio Fernández-Ortiz7, Agustín Mocoroa8, Laura García-Leal4, Evelyn Cárdenas4, Carolina Rojas4, María I Martínez-Castro4, Silvia Santiago-Sacristán4, Miriam Fernández-Gallardo4, José M Mendiguren8, Sameer Bansilal9, Willem van Mechelen2, Valentín Fuster10. 1. Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands. Electronic address: j.coffeng@vumc.nl. 2. Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands. 3. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; HM Hospitales-Hospital Universitario HM Montepríncipe. 4. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain. 5. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Madrid, Spain. 6. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Hospital Universitario Quirónsalud-Universidad Europea de Madrid, Spain. 7. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Hospital Clínico San Carlos, Universidad Complutense, Madrid, Spain. 8. Banco de Santander, Madrid, Spain. 9. Icahn School of Medicine at Mount Sinai, New York, NY. 10. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: valentin.fuster@mountsinai.org.
Abstract
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. OBJECTIVE: The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. METHODS: We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. CONCLUSIONS: The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB.
RCT Entities:
BACKGROUND:Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. OBJECTIVE: The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. METHODS: We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. CONCLUSIONS: The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB.
Authors: Mei-Lan Liu; Chia-Hui Chang; Ming-Chun Hsueh; Yi-Jin Hu; Yung Liao Journal: Int J Environ Res Public Health Date: 2020-05-12 Impact factor: 3.390
Authors: Ines Garcia-Lunar; Hidde P van der Ploeg; Juan Miguel Fernández Alvira; Femke van Nassau; Jose Maria Castellano Vázquez; Allard J van der Beek; Xavier Rossello; Antonio Fernández-Ortiz; Jennifer Coffeng; Johanna M van Dongen; Jose Maria Mendiguren; Borja Ibáñez; Willem van Mechelen; Valentin Fuster Journal: Eur Heart J Date: 2022-10-11 Impact factor: 35.855
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