Background: A healthy diet is essential to reduce cardiovascular disease (CVD) risk and mortality. However, recent studies lack conclusive evidence on the affordability of cardioprotective diets worldwide. The Brazilian Cardioprotective Nutritional Program Trial (BALANCE Program) is a randomized multicenter clinical trial that proposes regionally adapted cardioprotective diet that achieves nutritional recommendations and incorporates accessible and affordable foods. The study aim is to analyze cost-effectiveness of the BALANCE Program in comparison to generic dietary advice for individuals, based on diet costs and nutritional quality among patients with high adherence to the study protocol in both control and intervention groups.
Methods: We conducted a cost-effectiveness analysis of subsample from the BALANCE Program (1,161 individuals with previous event of CVD and high adherence to study protocol enrolled in 35 research sites throughout Brazil) after a 3-year follow-up. Direct costs and nutritional quality of diets reported by participants were estimated at the individual level. Diet costs were based on market prices collected from five major supermarket chains. Effectiveness was measured in terms of diet quality, according to adherence to the Brazilian Health Eating Index Revised (BHEI-R). Mean differences were compared between groups using generalized estimating equation. Monte Carlo simulations were performed to comprise probabilistic sensitivity analysis regarding trends in the comparison between groups.
Results: At baseline, mean direct diet costs were equal (U$3.9/day), and there were small differences in BHEI-R between groups (53.5 points in BALANCE Program, and 51.8 points in control group). After the 3-year follow-up, the intervention was associated with a mean cost saving of U$0.31/day (95%CI: -0.59; -0.04) and mean BHEI-R increase of 4.38 (95%CI: 2.81; 5.95). The intervention was dominant strategy in terms of cost-effectiveness due to higher effectiveness at lower costs in comparison with the control group.
Conclusions : There was a statistically significant effect of the intervention regarding increase in diet quality and reduction in cost after 3 years compared to the control group. The BALANCE intervention may be an option to improve diet quality with lower costs among Brazilians with CVD. Trial registration NCT01620398. Registered June 2012. https://clinicaltrials.gov/ct2/show/NCT01620398