Clinical trial NCT02561065: Long-term Impact Evaluation of a Worksite-based Lifestyle Intervention to Reduce Cardiovascular Risk in Office Workers
Official title: Long-term Impact Evaluation of a Worksite-based Lifestyle Intervention to Reduce Cardiovascular Risk in Office Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Health Lifestyle
Lifestyle Risk Reduction
Health Behavior
Sedentary Lifestyle
Intervention Studies
Cardiovascular risk in office workers
Motivational Interview
Preventive health services
Health education
Physical activity
Dietary behaviour intervention
Workplace
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Instituto de Salud Carlos III
name: Icahn School of Medicine at Mount Sinai
First posted: 2015-09-25
Enrollment: 1020
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adapted FUSTER-BEWAT score (Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption and Smoking).
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
Secondary outcomes:
measure: Original FUSTER-BEWAT score.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
measure: Objective physical activity/sedentary time.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3
measure: Self-reported lifestyle behaviors.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3
measure: Physical assessments.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
measure: Cardio-metabolic biomarkers.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
measure: Psychosocial assessment.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
measure: Personal characteristics.
timeFrame: Changes between baseline, and Year 1, and Year 2 and Year 3.
measure: Economic evaluation.
timeFrame: Changes between 4 months up to 36 months (every 3 months measured).
measure: Intervention process measures.
timeFrame: Changes between baseline, 4 months and Year 1, and Year 2 and Year 3
Other outcomes:
Locations:
Study officials:
affiliation: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Valentin Fuster, MD, PhD
role: STUDY_CHAIR
affiliation: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Jose Maria Castellano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Hidde van der Ploeg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Willem van Mechelen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)
name: Borja Ibañez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)
name: Antonio Fernandez-Ortiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)
name: Ines García Lunar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Lunar I, van der Ploeg HP, Fernandez Alvira JM, van Nassau F, Castellano Vazquez JM, van der Beek AJ, Rossello X, Fernandez-Ortiz A, Coffeng J, van Dongen JM, Mendiguren JM, Ibanez B, van Mechelen W, Fuster V. Effects of a comprehensive lifestyle intervention on cardiovascular health: the TANSNIP-PESA trial. Eur Heart J. 2022 Oct 11;43(38):3732-3745. doi: 10.1093/eurheartj/ehac378.