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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-25

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

NCT06911294

Coronary Heart Disease

RECRUITING NA

Evaluation of a Lifestyle Intervention for Employees With Prediabetes

NCT01682954

Prediabetes Overweight Obese

COMPLETED NA

Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention

NCT05322876

Cardiovascular Diseases Metabolic Syndrome

RECRUITING NA

Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease

NCT05459987

Prediabetic State Coronary Heart Disease Healthy Lifestyle +1 more

COMPLETED NA

Preventative Screening and Health Coaching in a Food Insecure Population

NCT06907524

Cardiovascular Disease Prevention Cardiometabolic Diseases Cardiovascular Risk Factor +6 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lifestyle intervention high risk group.

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

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Lifestyle intervention low risk group.

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

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes