Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA; Department of Pediatrics, University of Colorado School of Medicine, 12348 E Montview Blvd C263, Aurora, CO 80045, USA; Department of Epidemiology, Colorado School of Public Health, 13001 E 17th Pl B119, Aurora, CO 80045, USA.
Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA.
Contemp Clin Trials. 2023 Oct;133:107305. doi: 10.1016/j.cct.2023.107305. Epub 2023 Jul 27.
Intrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring.
This two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28-32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies.
This clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations.
子宫内暴露于母体超重/肥胖或糖尿病会将风险传递给后代，使疾病在代际间持续存在。减少母体体重或血糖异常的产前干预措施效果有限，而产后干预措施只有在继续生育的情况下才能改变子宫内环境。需要有效的孕前干预措施，特别是针对服务不足的人群，并具有可持续扩大规模的潜力。还需要研究评估干预措施在受孕时、整个孕期和后代中的效果。
这是一项双臂、平行随机临床试验，将包括 360 名超重/肥胖且在 24 个月内有较高怀孕可能性的生物学女性。参与者将按 1:1 随机分为一年期孕前生活方式干预组，该干预组基于国家糖尿病预防计划（NDPP-NextGen）或常规护理。数据收集将在入组时（受孕前）、受孕后（<8 周妊娠）、妊娠晚期（28-32 周妊娠）和分娩时（出院前）进行，前提是参与者在入组后 24 个月内怀孕。主要结局是受孕后体重指数（<8 周妊娠；主要结局）、受孕后空腹血糖（<8 周妊娠；次要结局）和新生儿肥胖（出生后 2 天内）。还将收集其他临床、行为、围产期和后代数据，并储存生物样本（血液、尿液、粪便、脐带血），以备未来的辅助研究。
这项临床试验将评估一种干预模式（NDPP-NextGen），该模式有可能改善美国超过 50%的超重/肥胖或有妊娠糖尿病风险的女性的健康。如果成功，它可以在美国 1800 多家提供 NDPP 的组织中推广，造福后代健康。
