The diabetes prevention program: Recruitment methods and results

Richard R. Rubin, Wilfred Y. Fujimoto, David Marrero, Tina Brenneman, Jeanne B. Charleston, Sharon L. Edelstein, Edwin B. Fisher, Ruth Jordan, William C. Knowler, Lynne C. Lichterman, Melvin Prince, Patricia M. Rowe

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about US$1075 per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.

Original languageEnglish (US)
Pages (from-to)157-171
Number of pages15
JournalControlled Clinical Trials
Volume23
Issue number2
DOIs
StatePublished - 2002
Externally publishedYes

Fingerprint

Costs and Cost Analysis
Glucose Intolerance
Random Allocation
Informed Consent
Type 2 Diabetes Mellitus
Volunteers
Appointments and Schedules
Randomized Controlled Trials
Exercise
Diet

Keywords

  • Clinical trials
  • Cost
  • Diabetes prevention
  • Participant recruitment

ASJC Scopus subject areas

  • Pharmacology

Cite this

Rubin, R. R., Fujimoto, W. Y., Marrero, D., Brenneman, T., Charleston, J. B., Edelstein, S. L., ... Rowe, P. M. (2002). The diabetes prevention program: Recruitment methods and results. Controlled Clinical Trials, 23(2), 157-171. https://doi.org/10.1016/S0197-2456(01)00184-2

The diabetes prevention program : Recruitment methods and results. / Rubin, Richard R.; Fujimoto, Wilfred Y.; Marrero, David; Brenneman, Tina; Charleston, Jeanne B.; Edelstein, Sharon L.; Fisher, Edwin B.; Jordan, Ruth; Knowler, William C.; Lichterman, Lynne C.; Prince, Melvin; Rowe, Patricia M.

In: Controlled Clinical Trials, Vol. 23, No. 2, 2002, p. 157-171.

Research output: Contribution to journalArticle

Rubin, RR, Fujimoto, WY, Marrero, D, Brenneman, T, Charleston, JB, Edelstein, SL, Fisher, EB, Jordan, R, Knowler, WC, Lichterman, LC, Prince, M & Rowe, PM 2002, 'The diabetes prevention program: Recruitment methods and results', Controlled Clinical Trials, vol. 23, no. 2, pp. 157-171. https://doi.org/10.1016/S0197-2456(01)00184-2
Rubin, Richard R. ; Fujimoto, Wilfred Y. ; Marrero, David ; Brenneman, Tina ; Charleston, Jeanne B. ; Edelstein, Sharon L. ; Fisher, Edwin B. ; Jordan, Ruth ; Knowler, William C. ; Lichterman, Lynne C. ; Prince, Melvin ; Rowe, Patricia M. / The diabetes prevention program : Recruitment methods and results. In: Controlled Clinical Trials. 2002 ; Vol. 23, No. 2. pp. 157-171.
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