Long-term Impact Evaluation of a Worksite-based Lifestyle Intervention to Reduce Cardiovascular Risk in Office Workers (TANSNIP-PESA)

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Status: Completed

Conditions: Atherosclerosis

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02561065

TANSNIP CNIC-VUMC-SANTANDER

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,020 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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).
2. Employees to be included need to be 1 year before PESA 2/3 visit (-1/ +2 months deviation).
3. 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.

Exclusion criteria

1. 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).
2. Active treatment for cancer, history of transplant with active immunosuppressive or immunomodulator treatment.
3. Morbid obesity (body mass index ≥40 kg/m2).
4. Presence of any disease that decreases life expectancy to 3 years, or any condition that could affect adherence to the study procedures.
5. Participants are also excluded if they are pregnant or lactating women.
6. Employees without plaque burden, a healthy BMI and a healthy lifestyle will be excluded from the RCT.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,020 participants in 4 patient groups

Lifestyle intervention high risk group.

Experimental group

Description:

Participants in the intervention group will receive the intervention on top of standard care.

Treatment:

Behavioral: Lifestyle intervention

Standard care high risk group.

No Intervention group

Description:

Each participant in the standard care group will receive care as usual, provided by his own occupational physician (OP) and other possible care providers.

Lifestyle intervention low risk group.

Experimental group

Description:

Participants in the intervention group will receive the intervention on top of standard care.

Treatment:

Behavioral: Lifestyle intervention

Standard care low risk group.

No Intervention group

Description:

Each participant in the standard care group will receive care as usual, provided by his own occupational physician (OP) and other possible care providers.