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

April 27, 2021 updated by: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1020

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle intervention high risk group.
Participants in the intervention group will receive the intervention on top of standard care.
Behavioral: Lifestyle intervention
  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.
NO_INTERVENTION: Standard care high risk group.
Each participant in the standard care group will receive care as usual, provided by his own occupational physician (OP) and other possible care providers.
EXPERIMENTAL: Lifestyle intervention low risk group.
Participants in the intervention group will receive the intervention on top of standard care.
Behavioral: Lifestyle intervention
  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.
NO_INTERVENTION: Standard care low risk group.
Each participant in the standard care group will receive care as usual, provided by his own occupational physician (OP) and other possible care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adapted FUSTER-BEWAT score (Blood pressure, Physical activity, Sedentary time, Body Mass Index, Fruit and Vegetable Consumption and Smoking).
Time Frame: 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.
Changes between baseline, and Year 1, and Year 2 and Year 3.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Original FUSTER-BEWAT score.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3.
The initial FUSTER-BEWAT score will also be calculated in addition as a secondary outcome for future testing of psychometric properties of the adapted FUSTER-BEWAT score
Changes between baseline, and Year 1, and Year 2 and Year 3.
Objective physical activity/sedentary time.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3
Physical activity and sedentary time will be objectively assessed with an activPAL activity monitor (PAL technologies Limited, Glasgow, UK). Participants will also complete a short daily diary, reporting the exact wearing times.
Changes between baseline, and Year 1, and Year 2 and Year 3
Self-reported lifestyle behaviors.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3

The following questionnaires regarding physical activity and sedentary behavior will be administered: the International Physical Activity Questionnaire (IPAQ short form) (also at 4 and 6 months); the Occupational Sitting and Physical Activity Questionnaire (OSPAQ) (also at 4 and 6 months); the Workforce Sitting Questionnaire (WSQ) (also at 4 and 6 months); and single questions to assess average daily standing.

Data on dietary habits will be collected (also at 4 months) with the Mediterranean Diet Adherence Screener (MEDAS).

Smoking status will be a self-reported measure, as well as the average number of cigarettes or other tobacco products consumed daily.

Further, sleeping will be measured using the Sleep Habits Questionnaire developed by the Sleep Heart Health Study.
Changes between baseline, and Year 1, and Year 2 and Year 3
Physical assessments.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3.
Waist circumference, body height, body weight, and blood pressure.
Changes between baseline, and Year 1, and Year 2 and Year 3.
Cardio-metabolic biomarkers.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3.
Complete blood count and chemistry panel as well as specific biomarkers related to subclinical atherosclerosis will be obtained.
Changes between baseline, and Year 1, and Year 2 and Year 3.
Psychosocial assessment.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3.

Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Perceived stress will be measured using the Perceived Stress Scale (PSS).

Social support will be measured using the official Spanish translated ENRICHD Social Support Instrument (ESSI).

Job strain will be measured with an adapted version of the official Spanish translation of the Job Content Questionnaire (JCQ).

Quality of life will be self-reported using the EuroQol (EQ-5D-5L). Relaxation and detachment after work will be measured using the Recovery Experience Questionnaire.

Self-rated health will be assessed with the EuroQol Visual Analogue Scale (EQ VAS).

Vitality will be measured using the Vitality questionnaire (VITA-16).
Changes between baseline, and Year 1, and Year 2 and Year 3.
Personal characteristics.
Time Frame: Changes between baseline, and Year 1, and Year 2 and Year 3.
Sociodemographic information, including age, gender, marital status, working hours per week, employment status, job type, income and education level, will be assessed.
Changes between baseline, and Year 1, and Year 2 and Year 3.
Economic evaluation.
Time Frame: Changes between 4 months up to 36 months (every 3 months measured).
To evaluate the cost-effectiveness of the lifestyle program, sickness absenteeism, presenteeism (i.e., working while feeling ill) and healthcare consumption (e.g. general practitioner, allied health professionals, complementary medicine consumption) will be assessed every 3 months until 36 months after baseline. Sickness absenteeism and presenteeism will be assessed with items from the WHO Health and Work Performance Questionnaire (WHO-HPQ). Presenteeism is conceptualized in the WHO-HPQ as a measure of actual work performance in relation to best performance, irrespective of the presence or absence of health complaints. Sickness absenteeism will be self-reported using the WHO-HPQ in hours per month.
Changes between 4 months up to 36 months (every 3 months measured).
Intervention process measures.
Time Frame: Changes between baseline, 4 months and Year 1, and Year 2 and Year 3
Feasibility of the program using quantitative and qualitative methods on three levels: the participant, the psychologist and the stakeholder.
Changes between baseline, 4 months and Year 1, and Year 2 and Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborators

Icahn School of Medicine at Mount Sinai
Amsterdam UMC, location VUmc
Instituto de Salud Carlos III

Investigators

  • Study Chair: Valentin Fuster, MD, PhD, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
  • Principal Investigator: 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.)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2015

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (ESTIMATE)

September 25, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TANSNIP CNIC-VUMC-SANTANDER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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