针对有妊娠糖尿病风险的南亚妇女的文化定制个性化营养干预 (DESI-GDM)
2025年5月5日 更新者：McMaster University
该试验将评估针对南亚高危妊娠女性的文化定制、个性化营养干预对口服葡萄糖负荷（通过葡萄糖曲线下面积测量）的血糖反应的影响。
该干预措施针对两个高危人群：母亲和婴儿，“打破了母亲妊娠期血糖异常、婴儿过度肥胖和胰岛素抵抗以及母亲和婴儿心血管疾病的循环”。
这项研究的结果对于指导未来以证据为基础的建议和公共卫生政策非常重要，以管理有 GDM 风险的孕妇的妊娠期血糖。
研究概览
详细说明
DESI-GDM 研究是一项随机研究，旨在评估针对南亚高危妊娠女性的文化定制个性化营养干预对口服葡萄糖负荷的血糖反应的影响。 符合条件的南亚孕妇将被随机分配到干预组或对照组。
南亚人（SA），其祖先来自印度、巴基斯坦、孟加拉国或斯里兰卡，是加拿大最大的非白人族群，是2型糖尿病（T2DM）和早期心血管疾病的高危人群（化学气相沉积）。 SA 女性患妊娠糖尿病 (GDM) 的风险至少是欧洲白人女性的两倍，后代发生 T2DM 的风险因素包括较高的出生体重、更多的脂肪组织和胰岛素敏感性降低，在 SA 婴儿中更常见GDM 高于非 GDM 母亲所生婴儿。
基于南亚前瞻性出生队列 (START) 的发现，我们确定饮食是 GDM 的一个关键的可改变风险因素，我们开发了一种饮食干预措施。 与我们交谈的女性表示希望更多地了解健康饮食以预防孕期糖尿病，并热衷于使用移动健康技术。
这项在南亚裔孕妇中进行的试验的目的是：
- 评估由训练有素的健康教练提供的符合文化背景的个性化营养干预措施的有效性，以比通常的饮食建议更有效地改善南亚女性的血糖水平。
- 评估由训练有素的健康教练向南亚孕妇提供的符合文化背景的个性化营养干预在比通常的饮食建议更大程度上降低妊娠糖尿病发病率的有效性。
这项研究的结果对于指导未来以证据为基础的建议和公共卫生政策非常重要，以管理有 GDM 风险的孕妇的妊娠期血糖。
研究类型
介入性
注册 (实际的)
140
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
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Hamilton、Ontario、加拿大、L8S4K1
- Farah Khan
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- 孕
- 南亚血统
- 妊娠第 12-18 周
- 单胎妊娠
以下至少 2 项：
- 年龄 > 29
- 低饮食质量（通过简短的饮食问卷评估）
- 一级亲属有2型糖尿病家族史
- 之前怀孕期间的妊娠糖尿病
- 孕前体重指数≥23.17
排除标准：
- 1 型或 2 型糖尿病
- 高血压（>140 毫米汞柱收缩压或 >90 毫米汞柱舒张压）
- 英语不好
- 不愿意改变饮食
- 妊娠期糖尿病以外的不良妊娠结局风险高（例如 双胞胎或多胞胎、使用生育治疗、既往高血压、前置胎盘或早产史）
- 参加另一项研究
- 没有智能手机
- 不愿意走路
- 过度恶心和/或呕吐
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：饮食干预
将为每位女性制定个性化的营养计划，并将尊重基于信仰的食物选择和地区偏好。
该计划将由文化上一致的健康教练提供，并通过设定 2-4 个“SMART”目标来考虑基线饮食摄入量、建议的妊娠期体重增加的能量平衡、个人价值观和偏好。
分配到干预组的参与者将收到短信。
分配到干预组的参与者将获得一个 Fitbit 来跟踪他们的步数，并且每周都会收到简单的短信，旨在增加步行量。
他们将获得 PDF 资源，这些资源提供有关怀孕期间健康饮食、身体活动和其他生活方式因素的建议，以及专门为南亚社区改编的其他材料。
|
熟悉南亚食物的营养师将为每位参与者制定个性化的饮食建议。
|
|
有源比较器：控制
对照组的参与者每周都会收到简单的短信，旨在增加步行量。
他们将获得 PDF 资源，这些资源提供有关怀孕期间健康饮食、身体活动和其他生活方式因素的建议，以及专门为南亚社区改编的其他材料。
|
将向对照组参与者提供 PDF、网站链接，以鼓励怀孕期间的健康饮食、体育锻炼和其他生活方式因素。
他们还将每周收到旨在增加步行的短信。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
葡萄糖曲线下面积（葡萄糖 AUC）
大体时间：3个月
|
血糖反应的测量，葡萄糖 AUC 是对 75 克口服葡萄糖耐量试验反应的连续测量，并使用空腹、1 小时和 2 小时葡萄糖通过梯形法计算。
|
3个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
妊娠糖尿病
大体时间：3个月
|
妊娠期糖尿病使用来自“Born in Bradford”的大量南亚女性的截断值进行分类：空腹血糖水平 >= 5.2 mmol/L，或 2 小时后负荷水平 >=7.2 mmol/ L.
|
3个月
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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孕妇血压
大体时间：3个月
|
我们在基线和 OGTT 就诊时测量母体血压。
|
3个月
|
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孕妇妊娠并发症
大体时间：3个月
|
怀孕并发症将在教练联系时被注意到。
|
3个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Russell J de Souza, ScD、McMaster University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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- Lapolla A, Dalfra MG, Ragazzi E, De Cata AP, Fedele D. New International Association of the Diabetes and Pregnancy Study Groups (IADPSG) recommendations for diagnosing gestational diabetes compared with former criteria: a retrospective study on pregnancy outcome. Diabet Med. 2011 Sep;28(9):1074-7. doi: 10.1111/j.1464-5491.2011.03351.x.
- Mission JF, Ohno MS, Cheng YW, Caughey AB. Gestational diabetes screening with the new IADPSG guidelines: a cost-effectiveness analysis. Am J Obstet Gynecol. 2012 Oct;207(4):326.e1-9. doi: 10.1016/j.ajog.2012.06.048. Epub 2012 Jun 29.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年11月26日
初级完成 (估计的)
2025年9月30日
研究完成 (估计的)
2025年12月31日
研究注册日期
首次提交
2018年7月12日
首先提交符合 QC 标准的
2018年7月23日
首次发布 (实际的)
2018年7月31日
研究记录更新
最后更新发布 (实际的)
2025年5月6日
上次提交的符合 QC 标准的更新
2025年5月5日
最后验证
2025年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
饮食干预的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人