Effects of a comprehensive lifestyle intervention on cardiovascular health: the TANSNIP-PESA trial

Ines Garcia-Lunar, Hidde P. van der Ploeg, Juan Miguel Fernández Alvira, Femke van Nassau, Jose Maria Castellano Vázquez, Allard J. van der Beek, Xavier Rossello, Antonio Fernández-Ortiz, Jennifer Coffeng, Johanna M. van Dongen, Jose Maria Mendiguren, Borja Ibáñez, Willem van Mechelen, Valentin Fuster

Research output: Contribution to journalArticlepeer-review

Abstract

AIMS: To investigate the effectiveness of a 3-year worksite lifestyle intervention on cardiovascular metrics and to study whether outcomes are influenced by baseline subclinical atherosclerosis (SA) by non-invasive imaging. METHODS AND RESULTS: A randomized controlled trial was performed to compare a lifestyle intervention with standard of care in asymptomatic middle-aged subjects, stratified by SA. The intervention consisted of nine motivational interviews during the first year, followed by three further sessions between Years 1 and 3. The primary outcome was the change in a pre-specified adaptation of the Fuster-BEWAT score (Blood pressure, Exercise, Weight, Alimentation, and Tobacco) between baseline and follow-up Years 1-3. A total of 1020 participants (mean age 50 ± 4 years) were enrolled, of whom 510 were randomly assigned to the intervention and 510 to the control group. The baseline adapted Fuster-BEWAT score was 16.2 ± 3.7 points in the intervention group and 16.5 ± 3.5 points in the control group. At Year 1, the score improved significantly in intervention participants compared with controls [estimate 0.83 (95% CI 0.52-1.15) points]. However, intervention effectiveness decreased to non-significant levels at Year 3 [0.24 (95% CI -0.10 to 0.59) points]. Over the 3-year period, the intervention was effective in participants having low baseline SA [0.61 (95% CI 0.30-0.93) points] but not in those with high baseline SA [0.19 (95% CI -0.26 to 0.64) points]. CONCLUSION: In middle-aged asymptomatic adults, a lifestyle intervention was associated with a significant improvement in cardiovascular health and behavioural metrics. The effect attenuated after 1 year as the intensity of the intervention was reduced. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02561065).

Original languageEnglish
Pages (from-to)3732-3745
Number of pages14
JournalEuropean Heart Journal
Volume43
Issue number38
DOIs
StatePublished - 11 Oct 2022
Externally publishedYes

Keywords

  • Cardiovascular
  • Lifestyle intervention
  • Randomized controlled trial
  • Subclinical atherosclerosis

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