Innovative population-based strategies for primary prevention of cardiovascular disease: A 2-year randomised control trial evaluating behavioral change led by community champions versus brief advice.

Cardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2019. General CVD prevention should be developed whilst controlling health expenditure. The aim of the SPICES project was to assess the efficacy of a community support intervention for adults with intermediate CVD risk at 24 months, compared to repeated brief advice alone. A randomised, controlled study was conducted in a poor, medically underserved, rural area in France from November 2019 to November 2021. Community champions lead small group sessions. They were specifically trained in behavioural change techniques and CVD prevention. Participants chose their own small, feasible cardiovascular health goals. The primary outcome was the difference in the Non-laboratory Interheart risk score (INL) in intention-to-treat at 24 months. Quality of life was assessed using the WHOQOL-BREF, diet using the DASH-questionnaire, physical activity using the IPAQ-short. Changes in BMI, smoking level, and self-declared alcohol consumption were recorded as health goals in the intervention group.1309 participants were eligible. 536 people were analysed. At 24 months, the difference Intervention-Control = -0.12 INL (95% CI -0.80 to 1.04) was not significant (p = 0.76). 257 people remained in the study. Most participants chose weight-loss as their objective. Although this study was impacted by the Covid-19 pandemic, pertinent observations were made. Participants spontaneously chose to lose weight, which was not an effective goal. The study was neglected by participants which suggests this population felt little concerned about CVD-prevention. Other awareness strategies should be developed. Public policies should be developed as individuals currently fail to improve their health. Trial registration: This trial is registered at clinicaltrials.gov (NCT0388606).