TAN-SNIP AIM 1: long term impact evaluation of a worksite-based lifestyle intervention to reduce imaging characterized-cardiovascular risk in office workers: Two parallel randomized controlled trials (WC2015-002)

Methods

Starting date: 01/01/2015

Two parallel RCTs, with equal block randomization, single blind, nested within the ´Progression of Early Subclinical Atherosclerosis´ (PESA) cohort will be conducted. One RCT (n= 350) will focus on a sample of employees drawn from the cohort with high imaging-defined SAPB and a second RCT (n=650) will focus on employees with low imaging-defined SAPB. In both RCTs, the participants (aged 40-60) will be randomized into either a group receiving a 3-year lifestyle program or receiving standard care. The program primarily aims to improve dietary, physical activity and sedentary behaviors consisting of three elements: (A) 12-personalized lifestyle counseling sessions over a 30-month period, (B) a wrist-worn physical activity tracker, and (C) a sit-stand workstation. Primary outcome measure is a compilation score of blood pressure, physical activity, sedentary time, body weight, diet and smoking (adapted-BEWAT), which will be collected at baseline and at 1, 2 and 3-year follow-up. Physical activity and sedentary time will be assessed objectively with an activPAL activity monitor. Questionnaires are used to assess: diet, smoking, sleep habits, depression, perceived stress, job strain, social support, vitality, relaxation, quality of life, health care consumption and intervention processes. Physical measurements include anthropometrics, noninvasive imaging to assess SAPB, and blood biomarkers. A process evaluation and a cost-effectiveness evaluation will be conducted.