Age, race and ethnicity, and sex of participants in clinical trials related to obesity

Abstract

Objective: Federal policies mandate the inclusion of historically marginalized groups in clinical trials and sociodemographic reporting on ClinicalTrials.gov. This study used ClinicalTrials.gov to comprehensively assess sociodemographic reporting and representation in obesity-related trials.

Methods: Age, race and ethnicity, and sex data were extracted for interventional studies completed in the United States with results from January 1, 2012, to October 13, 2023. We assessed the frequency of sociodemographic reporting and sample representation (equitable, over, or under), as determined by comparing the percentage of trial participants with each characteristic to US Census data and obesity-specific estimates.

Results: The search yielded 847 study records, 449 of which were eligible. Most studies (>99%) reported sex; older age (33%), race (75%), and ethnicity (57%) were less commonly reported, although race and ethnicity reporting increased over time (p values <0.001). The following three patterns emerged for representation: 1) individuals identifying as Black/African American were slightly overrepresented relative to the comparators; 2) representation of older adults and other racial and ethnic identities was more mixed and differed by trial type; and 3) female participants were overrepresented.

Conclusions: Progress has been made in reporting and representation, although gaps remain. Given obesity-related health disparities and reasons for inclusion beyond population-based representation (e.g., subgroup analyses), continued efforts are needed to enhance reporting and representation.