怀孕前的临床试验,以减少代际肥胖和糖尿病风险:NDPP-NextGen试验协议
Katherine A Sauder1, Katharine Gamalski2, Jayna DeRoeck3
1Lifecourse 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.
这项研究测试了超重/肥胖妇女的生活方式干预措施,以改善怀孕前的母亲和婴儿健康. 目标是打破疾病传播的代际循环.
科学领域:
- 生殖健康 生殖健康
- 公共卫生 公共卫生
- 代谢障碍 代谢障碍 代谢障碍
背景情况:
- 孕产妇超重/肥胖和糖尿病构成代际健康风险.
- 目前的产前和产后干预措施的有效性有限.
- 对于可扩展的预先概念干预措施有极大需求.
研究的目的:
- 评估国家糖尿病预防计划 (NDPP-NextGen) 作为一种预先概念的生活方式干预措施.
- 评估干预对母亲健康标志物和后代结果的影响.
- 为了确定扩展这种干预模型的可行性.
主要方法:
- 一个双臂,并行随机临床试验,涉及360名超重/肥胖妇女.
- 随机选择为为期一年的预孕生活方式干预 (NDPP-NextGen) 或常规护理.
- 在多个时间点收集数据:入学,怀孕后,怀孕晚期和分娩.
主要成果:
- 主要结果:怀孕后的体重指数.
- 二次结局:怀孕后的禁食葡萄糖和新生儿脂肪.
- 收集广泛的临床,行为,围产和后代数据,包括生物样本.
结论:
- 这项研究将评估一种干预模型 (NDPP-NextGen),以改善孕妇妊娠并发症风险的妇女的孕产妇健康.
- 成功的结果可能会导致在1800多个组织中广泛实施.
- 这种干预有可能有利于未来几代人的健康.
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