Recruitment in a Pediatric Clinical Research Trial Targeting Underserved Populations: Efforts and Challenges
|Kathy A. Ireland1, Aaron J. Manders1*, Barbara E. Corkey2 and Carine M. Lenders1|
|1Boston Medical Center, USA|
|2Boston University School of Medicine, USA|
|Corresponding Author :||Aaron J. Manders, MS, RD, LDN
Boston Medical Center, 88 E. Newton St.
Vose 507 Boston, MA 02118, USA
E-mail: [email protected]
|Received May 06, 2015; Accepted May 26, 2015; Published June 05, 2015|
|Citation: Ireland KA, Manders AJ, Corkey BE, Lenders CM (2015) Recruitment in a Pediatric Clinical Research Trial Targeting Underserved Populations: Efforts and Challenges. J Obes Weight Loss Ther 5:262. doi:10.4172/2165-7904.1000262|
|Copyright: © 2015 Ireland KA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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.