A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial - 18/04/17
, Hidde P van der Ploeg, PhD a, José M Castellano, MD, PhD b, c, Juan M Fernández-Alvira, PhD b, Borja Ibáñez, MD, PhD b, d, Inés García-Lunar, MD b, e, Allard J van der Beek, PhD a, Antonio Fernández-Ortiz, MD, PhD b, f, Agustín Mocoroa, MD g, Laura García-Leal b, Evelyn Cárdenas b, Carolina Rojas b, María I Martínez-Castro, PhD b, Silvia Santiago-Sacristán b, Miriam Fernández-Gallardo b, José M Mendiguren, MD g, Sameer Bansilal, MD h, Willem van Mechelen, MD, PhD a, Valentín Fuster, MD, PhD b, h, ⁎ 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.
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| Trial registration: NCT02561065. |
Vol 184
P. 121-132 - febbraio 2017 Ritorno al numero
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