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

NCT02561065 | Completed DMC

• 1 other identifier: TANSNIP CNIC-VUMC-SANTANDER
• Study Type: interventional
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Adapted FUSTER-BEWAT score (Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption and Smoking).

  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.

  Changes between baseline, and Year 1, and Year 2 and Year 3.

Secondary Outcomes (9)

• 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

• Self-reported lifestyle behaviors.

  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.

• Cardio-metabolic biomarkers.

  Changes between baseline, and Year 1, and Year 2 and Year 3.

Study Arms (4)

Lifestyle intervention high risk group.

EXPERIMENTAL

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

Behavioral: Lifestyle intervention

Standard care high risk group.

NO INTERVENTION

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

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

Behavioral: Lifestyle intervention

Standard care low risk group.

NO INTERVENTION

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

Interventions

Lifestyle intervention BEHAVIORAL

1. Each participant will receive 12 personalized lifestyle counseling sessions given face-to-face by a trained practitioner. 2. The Fitbit physical activity tracker gives summaries of the participant's physical activity, provides stimulating prompts and rewards, and allows for social media sharing and competition. 3. A Sit-stand workstation allows to adjust the height of the participant workstation, including the computer screen, keyboard and mouse and allows them to easily switch between sitting and standing throughout the workday.

Lifestyle intervention high risk group.; Lifestyle intervention low risk group.

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: lead
• Amsterdam UMC, location VUmc: collaborator
• Instituto de Salud Carlos III: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Related Publications (1)

• 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.

  PMID: 35869885 DERIVED

Related Links

• A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial

MeSH Terms

Conditions

Atherosclerosis; Risk Reduction Behavior; Health Behavior; Sedentary Behavior; Health Education; Motor Activity

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Valentin Fuster, MD, PhD

  Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

  STUDY CHAIR

• Jose Maria Castellano, MD, PhD

  Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

  PRINCIPAL INVESTIGATOR

• Hidde van der Ploeg, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Willem van Mechelen, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Borja Ibañez, MD, PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)

  PRINCIPAL INVESTIGATOR

• Antonio Fernandez-Ortiz, MD, PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)

  PRINCIPAL INVESTIGATOR

• Ines García Lunar, MD, PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: September 25, 2015
• Study Start: May 25, 2015
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-03