Discussion
weight reduction, intentional behavior, BP decrease, hypertension, weight loss
CVD, MINOR, HYPERTENSION
In the broader effort to address the impact of high BP and CVD across populations, there is a pressing need to establish effective strategies for encouraging behavior changes (Our findings revealed that both interventions were effective in reducing DBP after 12 weeks. However, only the intervention focused on salt reduction was significantly effective in decreasing SBP, with a substantial mean reduction of −2.5 mm Hg after 12 weeks compared to baseline. Furthermore, the salt reduction program was more effective at reducing BP in participants with high-normal or hypertension at baseline (SBP ≥ 130 and/or DBP ≥ 85, mm Hg; Schematic representation of the clinical trial design, showing the major characteristics of the intervention groups. The outcome variables are highlighted as well as the major findings.The magnitude of our results in a short period is outstanding and consolidates the importance of diet and nutrition in the management of hypertension, independently of pharmacology. Because BP decrease is semilogarithmic associated with the incidence of cardiovascular outcomes, even a minor reduction has significant benefits (Nevertheless, it was somewhat surprising that the interventions yielded no significant impact on NaIndeed, the observed decrease in BP in our study can be attributed to the intentional behavior changes adopted by participants over the 12-week intervention period. Specifically, participants increased their consumption of vegetables, fruits, fish, tree nuts and dishes seasoned with sofrito, while reducing their intake of processed meats, butter, margarine, and high-sugar products. Significantly, these dietary changes comprise beneficial food ingredients that could account for the observed decrease in BP. Notably, the presence of vitamins and flavonoids in vegetables and fruits might induce blood vessel relaxation, driven by their antioxidant and anti-inflammatory properties (Furthermore, these dietary modifications yielded improvements in various anthropometric measures, ultimately contributing to the reduction in BP. While variations in body measurements did not result in a significant mean difference, a noticeable trend toward weight reduction was apparent. It is worth noting that weight loss constitutes a significant lifestyle factor in the prevention and management of hypertension, often influenced by dietary choices and physical activity (As expected, participants who achieved the largest reductions in NaAccording to current hypertension prevention guidelines, lifestyle changes such as a healthy diet are recommended for all patients as they can delay or complement ongoing treatment (The strengths of our study include a randomized design and a notably ample sample size. We employed an interdisciplinary empowerment-based approach by collaborating with a multidisciplinary team of 12 nutritionists operating within clinical and grocery shopping settings. Furthermore, we adopted a pragmatic approach, involving participants with hypertension and those using antihypertensive medications. Through this deliberate inclusion of individuals from this high-risk group, the applicability of the study findings to a broader population is enhanced, thereby increasing the generalizability of our findings. Lastly, we followed a standardized protocol and strict quality control procedures for clinical measurements and data collection, thus ensuring the accuracy and consistency of our data.On the other hand, this trial presents several limitations that warrant acknowledgment. Firstly, differences in group retention were noted, with a lower attrition rate observed among participants in the salt reduction program compared to the holistic healthy lifestyle group. This divergence could be attributed to the comparatively reduced contact inherent to the healthy lifestyle program, potentially leading to a diminished level of motivation among these participants. This variance in follow-up could potentially introduce bias favoring the salt reduction group. However, intention-to-treat analyses employing multiple imputation methods, to address missing data, yielded outcomes consistent with the complete-case analysis. Secondly, there was an imbalance in the sex distribution, with a higher proportion of women in the healthy lifestyle group. Nonetheless, we addressed this disparity by incorporating sex and participant compliance as covariates in the analysis to mitigate potential confounding effects. Thirdly, the study concluded before attaining the intended sample size of 500 participants. Although the study still encompassed a relatively substantial sample size, the failure to reach the target number might have impacted the statistical power to discern differences in outcome assessments between the groups. Fourth, due to ethical considerations, the study lacked a no-intervention control group, and the design did not allow double-blinding. Fifth, it is worth noting that participants who volunteer for dietary trials generally exhibit a higher degree of motivation to adhere to a dietary program compared to the broader population. Furthermore, most participants were professionally active and had higher levels of education, potentially facilitating a greater assimilation of knowledge. Consequently, the outcomes of the programs may not be as effective in the general population.