Long-term Impact Evaluation of a Worksite-based Lifestyle Intervention to Reduce Cardiovascular Risk in Office Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,020
- 主要终点
- Adapted FUSTER-BEWAT score (Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption and Smoking).
研究概览
简要总结
The main objective of TANSNIP-PESA is to determine in a population of asymptomatic bank employees with high and low imaging defined cardiovascular disease (CVD) risk the effectiveness of a comprehensive 3-year worksite-based lifestyle intervention consisting of 12 personalized lifestyle counseling sessions, a Fitbit physical activity tracker and a sit-stand Workstation.
详细描述
We will study 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 subclinical atherosclerotic plaque burden (SAPB), compared to standard care.
Methods: We will conduct a randomized controlled trial (RCT) including middle-aged bank employees from the ´Progression of Early Subclinical Atherosclerosis´ (PESA) cohort, stratified by SAPB. Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care.
The primary outcome measure is the adapted FUSTER-BEWAT CVD risk and lifestyle composite score and secondary outcome measures include physical activity, sedentary time, standing time, diet, smoking, anthropometric measures, blood biomarkers, self-rated health, work-related outcomes, healthcare consumption, program process measures and cost measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employees aged 40 to 60 years of the PESA (Progression of Early Subclinical Atherosclerosis) cohort study (48) from the Banco de Santander Headquarters in Madrid (Spain).
- •Employees to be included need to be 1 year before PESA 2/3 visit (-1/ +2 months deviation).
- •Employees that can be stratified into a high or low degree of imaging defined SAPB. High degree of imaging-defined SAPB will be defined as a high burden of atherosclerotic disease detected either by 2D ultrasound (upper tertile sum of maximum thickness of the plaques or coronary artery calcium score (CACS) by computed tomography ≥ 1 point). Low degree of imaging-defined SAPB will be defined as having a CACS Agatston score of zero and no plaque by 2D ultrasound or being in the lowest two tertiles of plaque burden. Participants without plaque burden but with a BMI ≥ 25, or; reporting at least one unhealthy lifestyle behavior in their last PESA visit (i.e., <150 min/wk of at least moderate intensity physical activity assessed by accelerometer, sitting >7 h/d as assessed by accelerometer, not meeting Mediterranean diet guidelines as assessed by a computerized dietary history tool previously developed and validated in the EPIC-Spain study and improved by ENRICA investigators, or smoking) will also be included in the low SAPB group.
排除标准
- •Prior history of cardiovascular disease (myocardial infarction, angina pectoris, stroke, peripheral vascular disease, aortic aneurysm, angioplasty, heart surgery, atrial fibrillation, or any other heart disease).
- •Active treatment for cancer, history of transplant with active immunosuppressive or immunomodulator treatment.
- •Morbid obesity (body mass index ≥40 kg/m2).
- •Presence of any disease that decreases life expectancy to 3 years, or any condition that could affect adherence to the study procedures.
- •Participants are also excluded if they are pregnant or lactating women.
- •Employees without plaque burden, a healthy BMI and a healthy lifestyle will be excluded from the RCT.
结局指标
主要结局
Adapted FUSTER-BEWAT score (Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption and Smoking).
时间窗: Changes between baseline, and Year 1, and Year 2 and Year 3.
Composite score consisting of: Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption (as a proxy for overall diet) and Smoking.
次要结局
- Psychosocial assessment.(Changes between baseline, and Year 1, and Year 2 and Year 3.)
- Economic evaluation.(Changes between 4 months up to 36 months (every 3 months measured).)
- Intervention process measures.(Changes between baseline, 4 months and Year 1, and Year 2 and Year 3)
- Original FUSTER-BEWAT score.(Changes between baseline, and Year 1, and Year 2 and Year 3.)
- Objective physical activity/sedentary time.(Changes between baseline, and Year 1, and Year 2 and Year 3)
- Physical assessments.(Changes between baseline, and Year 1, and Year 2 and Year 3.)
- Self-reported lifestyle behaviors.(Changes between baseline, and Year 1, and Year 2 and Year 3)
- Cardio-metabolic biomarkers.(Changes between baseline, and Year 1, and Year 2 and Year 3.)
- Personal characteristics.(Changes between baseline, and Year 1, and Year 2 and Year 3.)