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

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lifestyle intervention

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring 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

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Lifestyle intervention high risk group.

Standard care high risk group.

Lifestyle intervention low risk group.

Standard care low risk group.

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Original FUSTER-BEWAT score.

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

Objective physical activity/sedentary time.

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.

Self-reported lifestyle behaviors.

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.

Physical assessments.

Waist circumference, body height, body weight, and blood pressure.

Cardio-metabolic biomarkers.

Complete blood count and chemistry panel as well as specific biomarkers related to subclinical atherosclerosis will be obtained.

Psychosocial assessment.

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).

Personal characteristics.

Sociodemographic information, including age, gender, marital status, working hours per week, employment status, job type, income and education level, will be assessed.

Economic evaluation.

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.

Intervention process measures.

Feasibility of the program using quantitative and qualitative methods on three levels: the participant, the psychologist and the stakeholder.

Full Information

NCT ID

NCT02561065

First Posted

May 27, 2015

Last Updated

April 27, 2021

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02561065

Brief Title

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

Acronym

TANSNIP-PESA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

May 25, 2015 (Actual)

Primary Completion Date

January 30, 2020 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1020 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle intervention high risk group.

Arm Type

Experimental

Arm Description

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

Arm Title

Standard care high risk group.

Arm Type

No Intervention

Arm 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.

Arm Title

Lifestyle intervention low risk group.

Arm Type

Experimental

Arm Description

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

Arm Title

Standard care low risk group.

Arm Type

No Intervention

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle intervention

Intervention Description

Each participant will receive 12 personalized lifestyle counseling sessions given face-to-face by a trained practitioner. 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. 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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Original FUSTER-BEWAT score.

Description

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

Time Frame

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

Title

Objective physical activity/sedentary time.

Description

Time Frame

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

Title

Self-reported lifestyle behaviors.

Description

Time Frame

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

Title

Physical assessments.

Description

Waist circumference, body height, body weight, and blood pressure.

Time Frame

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

Title

Cardio-metabolic biomarkers.

Description

Complete blood count and chemistry panel as well as specific biomarkers related to subclinical atherosclerosis will be obtained.

Time Frame

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

Title

Psychosocial assessment.

Description

Time Frame

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

Title

Personal characteristics.

Description

Sociodemographic information, including age, gender, marital status, working hours per week, employment status, job type, income and education level, will be assessed.

Time Frame

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

Title

Economic evaluation.

Description

Time Frame

Changes between 4 months up to 36 months (every 3 months measured).

Title

Intervention process measures.

Description

Feasibility of the program using quantitative and qualitative methods on three levels: the participant, the psychologist and the stakeholder.

Time Frame

Changes between baseline, 4 months and Year 1, and Year 2 and Year 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials: