Daily Dietary Sodium Intake Among Clinical Trial Participants Recruited From a University Health System or a Federally Qualified Health Center: Secondary Analysis of Baseline Participant Characteristics.

Abstract

Background: Efforts to improve diversity in clinical trials often prioritize recruitment based on broad demographic factors. This approach may overlook the influence of community context and health-related social needs on health behaviors, including sodium intake, a key modifiable risk factor for hypertension and cardiovascular disease.

Objective: This study aims to assess the impact of enrollment site, sociodemographic factors, and health-related social needs on baseline dietary sodium intake among participants in a mobile health clinical trial aimed at lowering blood pressure.

Methods: The myBPmyLife study is a prospective, randomized controlled trial evaluating a mobile health intervention to lower blood pressure through increased physical activity and lower sodium food choices. Participants with hypertension were recruited from a university health system and a federally qualified health center (FQHC). All participants completed a validated sodium screener at enrollment. Sociodemographic data and health-related social needs were self-reported. Univariable and multivariable linear regression models were used to evaluate the associations between sodium intake and participant characteristics. This analysis presents a cross-sectional examination of the baseline characteristics of participants enrolled in the myBPmyLife study.

Results: Among 600 included participants, 96 (16.0%) were from the FQHC. Mean age was 60.1 (SD 13.5) years; 48.2% (289/600) were women, and 13.0% (78/600) were Black. FQHC participants were significantly younger (mean age 47.9, SD 11.1 vs 62.5, SD 12.7 years), more likely to be Black (43/96, 44.8% vs 35/504, 6.9%), and 8.5 times more likely to have difficulty paying for their health-related social needs. Mean baseline sodium intake was 3082.3 (SD 1072.5) mg/day, with 85.5% (513/600) of participants exceeding the World Health Organization's recommended daily sodium limit. Baseline sodium intake was significantly higher for FQHC participants (mean difference 381.1, SD 1064.2 mg/d; 95% CI 84.5-677.7; P=.01), men (mean difference 543.9, SD 1038.3 mg/d; 95% CI 377.3-710.5; P<.001), Black participants (mean difference 442.5, SD 1043.4 mg/d; 95% CI 119.7-765.3; P=.008) and those with difficulty affording basic needs (mean difference 338.1, SD 1066.7 mg/d; 95% CI 95.2-581.0; P=.02). Sodium intake was lower in older participants (-196.4 mg/d per 10 years; 95% CI -258.0 to -134.9; P<.001). In a multivariable analysis, age, gender, and race remained independently associated with sodium intake, while differences by site and health-related social needs were not statistically significant.

Conclusions: Differences in sodium intake were observed across sociodemographic groups. While the enrollment site was not independently associated with sodium intake after adjustment, it played a role in shaping the participant population, evidenced by the differences in demographics and health-related social needs among participants based on enrollment site. These findings underscore the importance of recruiting from distinct clinical settings to capture a range of contextual factors that influence health behaviors. Clinical trials aiming for representativeness should consider both individual- and community-level factors during recruitment to more accurately inform interventions and health outcomes.