Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE Phase 2) screening and recruitment: Methods and results

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• 作者：T.M. Stewart^a ; ^{tiffany.stewart@pbrc.edu} ; M. Bhapkar^b ; S. Das^c ; K. Galan^b ; C.K. Martin^a ; L. McAdams^b ; C. Pieper^b ; L. Redman^a ; S. Roberts^c ; R.I. Stein^d ; J. Rochon^b ; D.A. Williamson^a ; for the CALERIE Study Group
• 关键词：Aging ; Caloric restriction ; Randomized controlled trial ; Consort information ; Participant recruitment ; Participant screening
• 刊名：Contemporary Clinical Trials
• 出版年：2013
• 出版时间：January, 2013
• 年：2013
• 卷：34
• 期：1
• 页码：10-20
• 全文大小：352 K

文摘

The Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study is a systematic investigation of sustained 25 % calorie restriction (CR) in non-obese humans. CALERIE is a multicenter (3 clinical sites, one coordinating center), parallel group, randomized controlled trial. Participants were recruited, screened, and randomized to the CR or control group with a 2:1 allocation. Inclusion criteria included ages 21-50 years for men and 21-47 years for women, and a body mass index (BMI) of 22.0 ¡Ü BMI < 28.0 kg/m². Exclusion criteria included abnormal laboratory markers, significant medical conditions, psychiatric/behavioral problems, and an inability to adhere to the rigors of the evaluation/intervention schedule. A multi-stage screening process (telephone screen and 3 in-clinic visits) was applied to identify eligible participants. Recruitment was effective and enrollment targets were met on time. 10,856 individuals contacted the clinical sites, of whom 9787 (90 % ) failed one or more eligibility criteria. Of the 1069 volunteers who started the in-clinic screening, 831 (78 % ) were either ineligible or dropped. 238 volunteers were enrolled (i.e., initiated the baseline evaluations), 220 were randomized, and 218 started the assigned intervention (2 % from the first screening step). This study offered lessons for future multi-center trials engaging non-disease populations. Recruitment strategies must be tailored to specific sites. A multi-disciplinary screening process should be applied to address medical, physical, and psychological/behavioral suitability of participants. Finally, a multi-step screening process with simple criteria first, followed by more elaborate procedures has the potential to reduce the use of study resources.