title: A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial.
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.
authors.affiliation: 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.
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Coffeng
authors.affiliation: Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands.
authors.forename: Hidde P
authors.initials: HP
authors.lastname: van der Ploeg
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; HM Hospitales-Hospital Universitario HM Montepríncipe.
authors.forename: José M
authors.initials: JM
authors.lastname: Castellano
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Juan M
authors.initials: JM
authors.lastname: Fernández-Alvira
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: Borja
authors.initials: B
authors.lastname: Ibáñez
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Hospital Universitario Quirónsalud-Universidad Europea de Madrid, Spain.
authors.forename: Inés
authors.initials: I
authors.lastname: García-Lunar
authors.affiliation: Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands.
authors.forename: Allard J
authors.initials: AJ
authors.lastname: van der Beek
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Hospital Clínico San Carlos, Universidad Complutense, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Fernández-Ortiz
authors.affiliation: Banco de Santander, Madrid, Spain.
authors.forename: Agustín
authors.initials: A
authors.lastname: Mocoroa
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: García-Leal
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Cárdenas
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Carolina
authors.initials: C
authors.lastname: Rojas
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: María I
authors.initials: MI
authors.lastname: Martínez-Castro
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Santiago-Sacristán
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors.forename: Miriam
authors.initials: M
authors.lastname: Fernández-Gallardo
authors.affiliation: Banco de Santander, Madrid, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Mendiguren
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Sameer
authors.initials: S
authors.lastname: Bansilal
authors.affiliation: Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands.
authors.forename: Willem
authors.initials: W
authors.lastname: van Mechelen
authors.affiliation: 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.
authors.forename: Valentín
authors.initials: V
authors.lastname: Fuster
mesh_terms: D000328:Adult; D050197:Atherosclerosis / Q000517:prevention & control*; D001794:Blood Pressure; D001835:Body Weight; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D004032:Diet; D015444:Exercise; D005260:Female; D000072936:Fitness Trackers; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing; D009786:Occupational Health Services / Q000379:methods*; D011187:Posture; D040242:Risk Reduction Behavior; D057185:Sedentary Behavior; D012907:Smoking; D016540:Smoking Cessation; D016896:Treatment Outcome; D017132:Workplace