AtherosclerosisTANSNIP-PESANCT02561065

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

A study testing Lifestyle intervention in people with Atherosclerosis, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Atherosclerosis
What is being tested?: Lifestyle intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,020 participants
Where: No sites listed yet
Study dates: 25 May 2015to 30 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

About this study

Read the 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.

Conditions: Atherosclerosis
Being tested: Lifestyle intervention
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
Medical subject headings: Atherosclerosis, Risk Reduction Behavior, Health Behavior, Sedentary Behavior, Health Education, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lifestyle interventionBehavioural
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.

Study groups in NCT02561065
Study group	Role	What they receive
Lifestyle intervention high risk group.	Experimental	Participants in the intervention group will receive the intervention on top of standard care. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3.
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.
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3
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.
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3
Physical assessments.
Waist circumference, body height, body weight, and blood pressure.
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3.
Cardio-metabolic biomarkers.
Complete blood count and chemistry panel as well as specific biomarkers related to subclinical atherosclerosis will be obtained.
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3.
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).
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3.
Personal characteristics.
Sociodemographic information, including age, gender, marital status, working hours per week, employment status, job type, income and education level, will be assessed.
Measured: Changes between baseline, and Year 1, and Year 2 and Year 3.
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.
Measured: Changes between 4 months up to 36 months (every 3 months measured).
Intervention process measures.
Feasibility of the program using quantitative and qualitative methods on three levels: the participant, the psychologist and the stakeholder.
Measured: Changes between baseline, 4 months and Year 1, and Year 2 and Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201530 Jan 2020

First posted25 Sep 2015 (estimated)
Study start25 May 2015
Primary completion30 Jan 2020
Study completion30 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AtherosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,020 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02561065
Sponsor's protocol ID: TANSNIP CNIC-VUMC-SANTANDER
Acronym: TANSNIP-PESA
Status last verified: Mar 2021
First submitted: 27 May 2015
Last updated: 28 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 35869885

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
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All Atherosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Impact Evaluation of a Worksite-based Lifestyle Intervention to Reduce Cardiovascular Risk in Office Workers
ClinicalTrials.gov ID: NCT02561065
Acronym / sponsor ID: TANSNIP-PESA / TANSNIP CNIC-VUMC-SANTANDER
Conditions: Atherosclerosis
Keywords: Health Lifestyle, Lifestyle Risk Reduction, Health Behavior, Sedentary Lifestyle, Intervention Studies, Cardiovascular risk in office workers, Motivational Interview, Preventive health services
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,020 participants (actual)
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos IIIUniversity, hospital or other
Collaborators: Amsterdam UMC, location VUmc, Instituto de Salud Carlos III, Icahn School of Medicine at Mount Sinai
Study start: 25 May 2015 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 25 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Lifestyle intervention high risk group.	Experimental	Behavioral: Lifestyle interventionParticipants in the intervention group will receive the intervention on top of standard care.
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	Behavioral: Lifestyle interventionParticipants in the intervention group will receive the intervention on top of standard care.
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.

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lifestyle intervention1. 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.	Behavioural	Lifestyle intervention high risk group., Lifestyle intervention low risk group.

Primary outcome

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.

9 secondary outcomes

Original FUSTER-BEWAT score.
Time frame: 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
Self-reported lifestyle behaviors.
Time frame: 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.
Cardio-metabolic biomarkers.
Time frame: 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.
Personal characteristics.
Time frame: 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).
Intervention process measures.
Time frame: Changes between baseline, 4 months and Year 1, and Year 2 and Year 3

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Derived from this study: PubMed 35869885Garcia-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.
A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trialLink provided by the sponsor.

Related trials for Atherosclerosis

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Valentin Fuster, MD, PhD study chair

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Jose Maria Castellano, MD, PhD principal investigator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Hidde van der Ploeg, PhD principal investigator

Amsterdam UMC, location VUmc

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Atherosclerosis, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.