Nicklas Jacinda M, Skurnik Geraldine, Zera Chloe A, Reforma Liberty G, Levkoff Sue E, Seely Ellen W
Division of General Internal Medicine, University of Colorado School of Medicine, Anschutz Health and Wellness Center, Mailstop C263, 12348 E. Montview Blvd., Aurora, CO, 80045, USA.
Division of Diabetes, Hypertension and Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Matern Child Health J. 2016 Feb;20(2):261-9. doi: 10.1007/s10995-015-1825-8.
The postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge.
We adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH).
We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.
Our multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were more likely to present for the first study visit. Given the increased challenges of recruiting postpartum women with GDM into research studies, we believe our findings will be useful to other investigators seeking to study this population.
产后时期是近期患有妊娠期糖尿病（GDM）的女性预防糖尿病的一个机会窗口，但在此生命阶段招募临床试验参与者是一项重大挑战。
我们采用社会生态模型，在宏观（高或机构层面）、中观（中或提供者层面）和微观（个体）层面制定了多层次招募策略。我们的目标是在17个月内招募100名近期患有GDM的女性进入“产后平衡”随机对照试验。参与者被要求在产后6周、6个月和12个月参加三次面对面的研究访视。在产后六周的基线访视结束时，她们被随机分为对照组或基于网络的干预组。在招募期结束时，我们将已招募受试者的人口统计学特征与在布莱根妇女医院（BWH）分娩的患有GDM的所有女性进行了比较。
在156名接受资格评估的女性中，我们成功招募了107名（69%），其中大多数（92名）在孕期平均妊娠30（标准差±5）周时被招募，15名在产后平均2（标准差±3）周时被招募。78名受试者参加了初始基线访视，75名受试者在产后平均7（标准差±2）周时被随机分配到试验中。在17个月的招募期内，已招募受试者的年龄和种族/族裔与BWH的538例GDM分娩的总体人群相似。
我们的多层次方法使我们能够成功实现招募目标，并招募到近期患有GDM的女性的代表性样本。我们认为，我们最成功的策略包括使用专门的面对面招募人员、将招募融入临床流程、在招募方面保持灵活性、尽量减少参与障碍以及对提供者采用退出策略。虽然大多数女性是在孕期被招募的，但在产后早期被招募的女性更有可能参加首次研究访视。鉴于将患有GDM的产后女性招募到研究中的挑战增加，我们相信我们的研究结果将对其他试图研究该人群的研究者有用。
