Waselewski Marika, Plegue Melissa, Sonneville Kendrin, Resnicow Ken, Ghumman Aisha, Ebbeling Cara, Mahmoudi Elham, Sen Ananda, Wolfson Julia A, Chang Tammy
Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.
School of Public Health, University of Michigan, Ann Arbor, MI, United States.
JMIR Res Protoc. 2022 Aug 5;11(8):e40568. doi: 10.2196/40568.
Excessive weight gain during pregnancy is associated with complications for both the mother and her infant including gestational diabetes, hypertensive disorders, operative delivery, and long-term obesity. A healthy diet during pregnancy promotes healthy gestational weight gain and determines fetal epigenetic programming in infants that impacts risk for future chronic disease.
This project will examine the impact of grocery delivery during pregnancy on the weight, diet, and health outcomes of young pregnant women and their infants.
A three-arm randomized controlled trial design will be performed. A total of 855 young pregnant women, aged 14-24 years, from across the state of Michigan will be enrolled and randomized equally into the three study arms. Participants in arm one (control) will receive usual care from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); arm two will receive WIC plus biweekly grocery delivery; and arm three will receive WIC plus biweekly grocery and unsweetened beverage delivery. Weight will be assessed weekly during pregnancy, and total pregnancy weight gain will be categorized as above, below, or within guidelines. Additionally, dietary intake will be assessed at three time points (baseline, second trimester, and third trimester), and pregnancy outcomes will be extracted from medical records. The appropriateness of pregnancy weight gain, diet quality, and occurrence of poor outcomes will be compared between groups using standard practices for multinomial regression and confounder adjustment.
This study was funded in April 2021, data collection started in December 2021, and data collection is expected to be concluded in 2026.
This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income. The findings will inform policies and practices that promote a healthy diet during pregnancy, which has multigenerational impacts on health.
ClinicalTrials.gov NCT05000645; https://clinicaltrials.gov/ct2/show/NCT05000645.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40568.
孕期体重过度增加与母亲及其婴儿的并发症相关，包括妊娠期糖尿病、高血压疾病、手术分娩和长期肥胖。孕期健康饮食可促进孕期体重健康增加，并决定婴儿的胎儿表观遗传编程，这会影响未来患慢性病的风险。
本项目将研究孕期食品配送对年轻孕妇及其婴儿的体重、饮食和健康结局的影响。
将采用三臂随机对照试验设计。总共855名年龄在14至24岁之间、来自密歇根州各地的年轻孕妇将被纳入研究，并平均随机分为三个研究组。第一组（对照组）的参与者将接受妇女、婴儿和儿童特别补充营养计划（WIC）的常规护理；第二组将接受WIC加每两周一次的食品配送；第三组将接受WIC加每两周一次的食品和无糖饮料配送。孕期每周评估体重，孕期总体重增加将根据指南分为高于、低于或符合标准。此外，将在三个时间点（基线、孕中期和孕晚期）评估饮食摄入量，并从医疗记录中提取妊娠结局。将使用多项回归和混杂因素调整的标准方法比较各组之间孕期体重增加的适宜性、饮食质量和不良结局的发生率。
本研究于2021年4月获得资助，数据收集于2021年12月开始，预计数据收集将于2026年结束。
本研究将测试健康食品配送是否能改善低收入年轻妈妈的体重、饮食和妊娠结局。研究结果将为促进孕期健康饮食的政策和实践提供参考，这对健康具有多代影响。
ClinicalTrials.gov NCT05000645；https://clinicaltrials.gov/ct2/show/NCT05000645。
国际注册报告识别码（IRRID）：DERR1-10.2196/40568。
