Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population

Authors: VANDER WYST, KILEY - Arizona State University; OLSON, MICAH - Phoenix Children'S Hospital; HOOKER, ELVA - The Society Of St Vincent De Paul; SOLTERO, ERICA - Children'S Nutrition Research Center (CNRC); KONOPKEN, YOLANDO - Arizona State University; KELLER, COLLEEN - Arizona State University; CASTRO, FELIPE - Arizona State University; WILLIAMS, ALLISON - Arizona State University; FERNÁNDEZ, ARLENE - Arizona State University; PATRICK, DONALD - University Of Washington; AYERS, STEPHANIE - Arizona State University; HU, HOUCHUN - Hyperfine Research Inc; PEÑA, ARMANDO - Arizona State University; PIMENTEL, JANIEL - Phoenix Children'S Hospital; KNOWLER, WILLIAM - National Institute Of Diabetes And Digestive And Kidney Diseases; SHAIBI, GABRIEL - Arizona State University

Submitted to: Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/5/2020
Publication Date: 8/14/2020
Citation: Vander Wyst, K.B., Olson, M.L., Hooker, E., Soltero, E.G., Konopken, Y.P., Keller, C.S., Castro, F.G., Williams, A.N., Fernandez, A.D., Patrick, D.L., Ayers, S.L., Hu, H.H., Peña, A., Pimentel, J., Knowler, W.C., Shaibi, G.Q. 2020. Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population. Trials. 21:716. https://doi.org/10.1186/s13063-020-04658-8.
DOI: https://doi.org/10.1186/s13063-020-04658-8

Interpretive Summary: Hispanic youth experience higher rates of pediatric obesity and type 2 diabetes compared to non-Hispanic white youth. In order to address these disparities and prevent this costly disease, there is a critical need to develop diabetes prevention strategies that target high-risk youth at imminent risk for developing type 2 diabetes. However, recruiting high-risk youth remains a challenge and consequently, Hispanic youth are underrepresented in clinical diabetes research. The purpose of this study was to describe the recruitment process, yields, and associated costs of recruiting Hispanic youth to a diabetes prevention program. This study focused on a high-risk population of Hispanic youth with obesity and prediabetes. Recruitment occurred through referrals from community resources, clinics, media, and word of mouth, with a goal of recruiting 120 participants. Recruitment from clinics led to the greatest number of referrals; however, word of mouth led to the highest proportion of participants who met eligibility criteria and were enrolled in the study. Recruitment from community resources led to the second greatest number of referrals, yet it was the costliest recruitment strategy and the majority of youth recruited through this method were not eligibility for participation in this study. While clinical recruitment was the second costliest recruitment strategy, this study showed that developing recruitment partnerships with community-based clinics is an effective strategy for recruiting high-risk Hispanic youth to disease prevention programming. Diabetes prevention programs and interventions that include Hispanic youth should also use word of mouth for recruitment given that it led to a high yield of high-risk youth and does not cost. This information is useful for similar studies aiming to focus on this population and can assist researchers, clinicians, and community stakeholders, in reaching this health disparate population.

Technical Abstract: Prediabetes and diabetes disproportionately impact Latino youth, yet few diabetes prevention programs have prioritized inclusion of this underrepresented population. This report describes the recruitment process, yields, associated costs, and phenotypic characteristics of Latino youth with obesity and prediabetes enrolled in a randomized controlled diabetes prevention study in the USA. Recruitment efforts included referrals from clinics, community outlets, local media, and word of mouth with the goal of enrolling 120 Latino adolescents aged 12–16 with obesity (BMI>=95th percentile) and prediabetes. Prediabetes eligibility was determined by any of the following: HbA1c between 5.7 and 6.5%, fasting glucose between 100 and 125 mg/dL, or a 2-h glucose between 120 and 199 mg/dL following a 75-g oral glucose tolerance test (OGTT), but not meeting any of the diagnostic criteria for diabetes. Eligible participants were randomized 2:1 to either a 6-month community-based lifestyle intervention that included group nutrition and health education classes (1 day/week) and group exercise classes (2 days/week) or usual care control arm. Recruitment yields were determined by review of referral source in the study screening database. Recruitment costs were determined by an after-the-fact financial review of actual and in-kind costs. Participant phenotypic characteristics (i.e., demographics, anthropometrics, and biochemical data) were compared by recruitment strategy using a one-way ANOVA. Recruitment efforts covered 160 mile**2 (414 km**2) across 26 ZIP codes (postcode) in the Phoenix Metropolitan Area and yielded 655 referrals from clinics (n=344), community (n=143), media (n=137), and word-of-mouth (n=31). From this pool, 26% (n=167) did not meet general, pre-screening eligibility criteria; 29% (n=187) declined participation; and 10% (n=64) were unable to be contacted. A total of 237 youth were invited to the clinical research unit to determine final eligibility. Following the OGTT, 52% (n=122) met prediabetes criteria and 117 were subsequently randomized. Clinical recruitment yielded the highest number of referrals (53%; n=344) while word-of-mouth yielded the highest proportion (35%; n=11) of randomized participants per referred youth. There were no significant differences in anthropometric or biochemical measures among youth by recruitment strategy. Based upon final enrollment numbers, community recruitment was the costliest approach ($486/randomized participant) followed by clinical ($248/randomized participant) and media ($236/randomized participant). The ability to meet enrollment goals for a clinical trial of an underrepresented population required multiple recruitment strategies. Although strategies vary in yields and costs, it appears they produce similar phenotypical risk profiles of eligible youth.