Nimbalkar Somashekhar Marutirao, Patel Dipen Vasudev, Phatak Ajay Gajanan
Department of Pediatrics, Shree Krishna Hospital, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India.
Central Research Services, Charutar Arogya Mandal, Karamsad, Anand, Gujarat, India.
PLoS One. 2016 Oct 12;11(10):e0163502. doi: 10.1371/journal.pone.0163502. eCollection 2016.
Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study.
After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return.
Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children.
The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.
微量营养素缺乏可导致贫血、生长发育受限以及运动和认知发育不良。计划开展一项临床试验，以评估营养补充对学龄前儿童认知指标的影响。由于相关法律规定、研究界的顾虑以及入组困难，在儿童中开展临床试验颇具难度。我们进行了一项基于问卷的可行性调查，以评估家长对参与此类营养研究的兴趣。
经机构人类研究伦理委员会批准后，印度古吉拉特邦阿南德市瓦拉布维迪亚纳加尔的四所幼儿园园长同意参与。向参与学校的儿童发放了同意书和预测试问卷，让他们带回家让家长签字、填写并返还。
在总共发放的1049份同意书和问卷中，共收回602份（57.39%）已签字并填写的表格。尽管家长对研究需求有一定认识，但愿意让孩子参与为期6个月、无需采血等侵入性措施的研究的家长有180人（29.9%）。近一半（250人，41.5%）没有回应，超过四分之一（172人，28.6%）代表孩子拒绝参与。
学龄前儿童家长让孩子参与评估记忆等认知指标的营养干预研究的兴趣较低。了解导致参与临床试验人数减少的研究人群的促进因素和抑制因素，对于建立相关证据基础很有必要。
