Recruitment and retention of urban schoolchildren into a randomized double-blind vitamin D supplementation trial.

Recruitment and retention of urban schoolchildren into a randomized double-blind vitamin D supplementation trial.
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DOI:
10.1177/1740774514556551
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发表时间:
2015-02
期刊:
Clinical trials (London, England)
影响因子:
--
通讯作者:
Economos CD
Economos CD
中科院分区:
其他
文献类型:
--
作者:
Sacheck JM;Van Rompay MI;Olson EM;Chomitz VR;Goodman E;Gordon CM;Eliasziw M;Holick MF;Economos CD

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虽然在美国很少用于补充试验,但学校提供了临床设置的实用替代方案。我们描述了成功招募和保留城市学童进入6个月的随机双盲维生素D3补充试验。2011-2012年,波士顿地区8-15岁的城市学童通过课堂和礼堂的方式被招募。五种语言的知情同意书被寄回家给家长。保留方法包括定期打电话和完成研究访问的礼品卡。总共有691名学生入学。平均(SD)年龄为11.7(1.4)岁;59%的学生来自种族/少数民族,68%的学生有资格享受免费或减价的校餐。多层次、文化敏感、创造性的方法有助于成功招聘和留住人才。691名参与者中,81%完成了6个月的干预期。流失的原因包括错过预约和害怕抽血。来自高收入家庭的孩子比来自低收入家庭的孩子被保留(分别为85%对79%,P=0.04)。在6个月的补充期内需要三次空腹抽血是本研究中招募和保留儿童的限制因素。招募城市儿童参加以学校为基础的随机对照试验是一种可行的补充研究方法。在对不同人群进行干预研究时,特别关注社会经济地位较低的儿童可能会提高参与度和参与度。
While rarely used for supplementation trials in the U.S., schools present a practical alternative to a clinical setting. We describe the successful recruitment and retention of urban schoolchildren into a 6-month randomized, double-blind vitamin D3 supplementation trial. Boston-area urban schoolchildren, aged 8-15 years, were recruited in 2011-2012 through classroom and auditorium presentations. Informed consent forms in five languages were sent home to parents. Retention methods included regular telephone calls and gift cards for completed study visits. In total, 691 schoolchildren enrolled. Their mean (SD) age was 11.7 (1.4) years; 59% were from racial/ethnic minorities and 68% qualified for free or reduced-price school meals. Multi-level, culturally-sensitive, creative approaches contributed to success in recruitment and retention. Of 691 participants, 81% completed the 6-month intervention period. Reasons for attrition included missed appointments and fear of a blood draw. More children from households with higher incomes were retained than those from households with lower incomes (85% vs. 79%, respectively, P=0.04). The need for three fasting blood draws over the 6-month supplementation period was a limiting factor in the recruitment and retention of children in this study. Recruitment of urban children into a school-based randomized controlled trial represents a feasible approach for a supplementation study. Particular attention to children of lower socioeconomic status may enhance participation and retention when conducting intervention studies among diverse populations.
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