评估一项针对儿童肥胖的试验的招募方法：家庭健康随机对照试验。
Evaluation of recruitment methods for a trial targeting childhood obesity: Families for Health randomised controlled trial.
机构信息
Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
出版信息
Trials. 2015 Nov 25;16:535. doi: 10.1186/s13063-015-1062-x.
BACKGROUND
Recruitment to trials evaluating the effectiveness of childhood obesity management interventions is challenging. We report our experience of recruitment to the Families for Health study, a randomised controlled trial evaluating the effectiveness of a family-based community programme for children aged 6-11 years, versus usual care. We evaluated the effectiveness of active recruitment (contacting eligible families directly) versus passive recruitment (informing the community through flyers, public events, media).
METHODS
Initial approaches included passive recruitment via the media (newspapers and radio) and two active recruitment methods: National Child Measurement Programme (letters to families with overweight children) and referrals from health-care professionals. With slow initial recruitment, further strategies were employed, including active (e.g. targeted letters from general practices) and passive (e.g. flyers, posters and public events) methods. At first enquiry from a potential participant, families were asked where they heard about the study. Further quantitative (questionnaire) and qualitative data (one-to-one interviews with parents/carers), were collected from recruited families at baseline and 3-month follow-up and included questions about recruitment.
RESULTS
In total, 194 families enquired about Families for Health, and 115 (59.3 %) were recruited and randomised. Active recruitment yielded 85 enquiries, with 43 families recruited (50.6 %); passive recruitment yielded 99 enquiries with 72 families recruited (72.7 %). Information seen at schools or GP surgeries accounted for over a quarter of enquiries (28.4 %) and over a third (37.4 %) of final recruitment. Eight out of ten families who enquired this way were recruited. Media-led enquiries were low (5 %), but all were recruited. Children of families recruited actively were more likely to be Asian or mixed race. Despite extensive recruitment methods, the trial did not recruit as planned, and was awarded a no-cost extension to complete the 12-month follow-up.
CONCLUSIONS
The higher number of participants recruited through passive methods may be due to the large number of potential participants these methods reached and because participants may see the information more than once. Recruiting to a child obesity treatment study is complex and it is advisable to use multiple recruitment strategies, some aiming at blanket coverage and some targeted at families with children who are overweight.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN45032201 (Date: 18 August 2011).
背景
招募评估儿童肥胖管理干预措施有效性的试验具有挑战性。我们报告了 Families for Health 研究的招募经验，该研究是一项针对 6-11 岁儿童的基于家庭的社区方案的随机对照试验，与常规护理进行比较。我们评估了主动招募（直接联系符合条件的家庭）与被动招募（通过传单、公共活动、媒体向社区通报）的效果。
方法
最初的方法包括通过媒体（报纸和广播）进行被动招募，以及两种主动招募方法：国家儿童测量计划（向超重儿童的家庭发送信件）和医疗保健专业人员的转介。由于最初的招募进展缓慢，因此采用了进一步的策略，包括主动（例如，来自普通诊所的针对性信件）和被动（例如，传单、海报和公共活动）方法。当潜在参与者首次询问时，家庭被问及他们从何处听说该研究。从招募的家庭中收集了基线和 3 个月随访时的进一步定量（问卷）和定性数据（对父母/照顾者的一对一访谈），其中包括关于招募的问题。
结果
总共有 194 个家庭询问了 Families for Health，其中 115 个（59.3%）被招募并随机分组。主动招募产生了 85 次询问，有 43 个家庭被招募（50.6%）；被动招募产生了 99 次询问，有 72 个家庭被招募（72.7%）。在学校或全科医生诊所看到的信息占询问的四分之一以上（28.4%），占最终招募的三分之一以上（37.4%）。以这种方式询问的十个家庭中有八个被招募。媒体主导的询问率较低（5%），但都被招募了。通过主动方式招募的家庭的孩子更有可能是亚洲人或混血儿。尽管采用了广泛的招募方法，但该试验并未按计划招募，因此获得了免费延期以完成 12 个月的随访。
结论
通过被动方法招募的参与者人数较多，可能是因为这些方法覆盖了大量的潜在参与者，而且参与者可能不止一次看到过这些信息。招募儿童肥胖治疗研究非常复杂，建议使用多种招募策略，一些策略旨在全面覆盖，而另一些策略则针对超重儿童的家庭。
试验注册
当前对照试验 ISRCTN45032201（日期：2011 年 8 月 18 日）。
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