Tiffany Stewart|Manjushri Bhapkar|Sai Krupa Das|Katherine M Galan|Corby K. Martin|Luanne McAdams|Carl F. Pieper|Leanne M. Redman|Susan B. Roberts|Richard I. Stein|James Rochon|Donald A. Williamson
Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE Phase 2) screening and recruitment: Methods and results
Pennington Biomedical Research Center|Duke Medical Center|Tufts University|Duke Medical Center|Pennington Biomedical Research Center|Duke Medical Center|Duke Medical Center|Pennington Biomedical Research Center|Tufts University|Washington University in St. Louis|Duke Medical Center|Pennington Biomedical Research Center
comprehensive assessment longterm effects reducing intake energy phase 2 calerie study systematic investigation sustained 25 calorie restriction cr nonobese humans calerie multicenter 3 clinical sites one coordinating center parallel group randomized controlled trial participants recruited screened randomized cr control group 21 allocation inclusion criteria included ages 2150 years men 2147 years women body mass index bmi 220 bmi 280 kgm2 exclusion criteria included abnormal laboratory markers significant medical conditions psychiatricbehavioral problems inability adhere rigors evaluationintervention schedule multistage screening process telephone screen 3 inclinic visits applied identify eligible participants recruitment effective enrollment targets met time 10856 individuals contacted clinical sites 9787 90 failed one eligibility criteria 1069 volunteers started inclinic screening 831 78 either ineligible dropped 238 volunteers enrolled ie initiated baseline evaluations 220 randomized 218 started assigned intervention 2 first screening step study offered lessons future multicenter trials engaging nondisease populations recruitment strategies must tailored specific sites multidisciplinary screening process applied address medical physical psychologicalbehavioral suitability participants finally multistep screening process simple criteria first followed elaborate procedures potential reduce use study resources