JMIR Publications

ABSTRACT

Background:

Clinical trials increasingly focus on diverse recruitment based on demographic factors and health-related social needs.

Objective:

We sought to understand the impact of demographic factors and health-related social needs on dietary sodium intake in a contemporary trial.

Methods:

The myBPmyLife study is a prospective, randomized-controlled trial designed to evaluate a mobile health (mHealth) intervention to lower blood pressure through increased physical activity and lower sodium food choices. Hypertensive participants recruited from a university health system and federally qualified health center (FQHC) completed a baseline sodium screener. Univariable and multivariable models evaluated the association between sodium intake at baseline–a key inclusion criterion–and participant characteristics.

Results:

Of the 600 included participants, 96 (16.0%) were from the FQHC. Mean age was 60.1 (SD 13.5) years; 48.2% were women, and 13.0% were Black. Notable differences were seen between sites: FQHC participants were, on average, 14.6 years younger than university participants, more likely to be Black (44.8% versus 6.9%), and 8.5 times more likely to have difficulty paying for their health-related social needs. Sodium intake at baseline was significantly higher for FQHC participants (mean difference 381.1 mg/day; 95% CI 84.5 to 677.7; P=.012). Adjustments for demographic characteristics and health-related social needs mitigated differences in sodium intake between sites.

Conclusions:

In this clinical trial of an mHealth intervention, we found important participant differences in demographics and health-related social need-related factors based on the site of enrollment. As clinical trials recruit for diversity based on demographic characteristics, they may also benefit from diversifying enrollment sites to ensure truly representative populations. Clinical Trial: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05154929.