Recruitment and enrollment of African Americans into health promoting programs: the effects of health promoting programs on cardiovascular disease risk study

Abstract

ABSTRACT Objectives: Randomized controlled trials (RCT) often employ multiple recruitment methods to attract participants, however, special care must be taken to be inclusive of under-represented populations. We examine how recruiting from an existing observational study affected the recruitment of African Americans into a RCT that included yoga-based interventions. In particular, we report the recruitment success of The Effects of Health Promoting Programs (HPP) on Cardiovascular Disease Risk (NCT02019953), the first yoga-based clinical trial to focus only on African Americans. Design: To recruit participants, a multifaceted recruitment strategy was implemented exclusively in the Jackson Heart Study (JHS) cohort. The HPP recruited from the JHS cohort using direct mailings, signs and flyers placed around JHS study facilities, and through JHS annual follow-up interviews. Results: Enrollment into HPP was open to all active JHS participants that were eligible to return for the third clinic exam (n = 4644). The target sample size was 375 JHS participants over a 24 month recruitment and enrollment period. From the active members of the JHS cohort, 503 were pre-screened for eligibility in HPP. More than 90% of those pre-screened were provisionally eligible for the study. The enrollment goal of 375 was completed after a 16-month enrollment period with over 25% (n = 97) of the required sample size enrolling during the second month of recruitment. Conclusions: The findings show that participants in observational studies can be successfully recruited into RCT. Observational studies provide researchers with a well-defined population that may be of interest when designing clinical trials. This is particularly useful in the recruitment of a high-risk, traditionally underrepresented populations for non-pharmacological clinical trials where traditional recruitment methods may prolong enrollment periods and extend study budgets.