Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
| Icahn School of Medicine at Mount Sinai | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention high risk group. | Experimental | Participants 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 | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Changes between baseline, and Year 1, and Year 2 and Year 3. |
| Objective physical activity/sedentary time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 GarcÃa Lunar, MD, PhD | Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.) | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35869885 | Derived | 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. |
| Label | URL |
|---|---|
| A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D040242 | Risk Reduction Behavior |
| D015438 | Health Behavior |
| D057185 | Sedentary Behavior |
| D006266 | Health Education |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. | 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. | Waist circumference, body height, body weight, and blood pressure. | 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. | 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). | 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. | 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. | 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. | Changes between baseline, 4 months and Year 1, and Year 2 and Year 3 |
| D001519 |
| Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |