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Recruitment in a Pediatric Clinical Research Trial Targeting Underserved Populations: Efforts and Challenges | OMICS International | Abstract
ISSN: 2165-7904

Journal of Obesity & Weight Loss Therapy
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Research Article

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
Tel: 6174143582
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.

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.

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