Recruitment in a Pediatric Clinical Research Trial Targeting Underserved Populations: Efforts and Challenges

Abstract

Introduction: To describe recruitment difficulties in a pediatric clinical trial targeting underserved pediatric obese populations. Methods: We planned a 6-month randomized, double-blind, placebo-controlled clinical trial of glutamine vs. placebo, to reduce HOMA_IR and weight gain in obese adolescents. Participation required 5 visits at a research center at 8:00 AM. Cash incentives were provided at visits. After recruitment difficulties, study design was modified and recruitment efforts were intensified over a 14-week period. Subjects were recruited from Boston Medical Center’s (BMC) pediatric outpatient clinics including the pediatric obesity program (NFL) which was staffed by members of the research team. Results: 2002 adolescents were evaluated: 546 met BMI and age criteria. After further exclusions, 179 were eligible for a screening visit but only 4 attended. Additionally, 120 recruitment letters were sent to NFL patients, resulting in 4 attending a screening visit. Seven of the 8 adolescents attending a screening visit were from NFL, and 2 were randomized but subsequently lost to follow-up. Discussion: Recruitment of pediatric patients from low-income and minority populations at BMC to a clinical trial is difficult. Challenges included strict inclusion/exclusion criteria and rigid appointment schedules. Existing patientclinician relationships may increase recruitment. Future trials should use more flexible study designs.