增强尼日利亚的代际健康：围产期是心血管健康的关键生命阶段 (ENHANCE-CVH)
2026年7月22日 更新者：Mark Huffman、Washington University School of Medicine
ENHANCE-CVH 研究的目的是促进阿布贾和尼日利亚联邦首都周边地区妇女和儿童的代际心血管健康 (CVH)。 研究小组计划通过调整现有的基于证据的干预措施来实现这一目标，即家长作为教师（PAT）课程+家庭健康饮食积极生活教学（HEALTH）——针对尼日利亚肥胖孕妇及其子女。 本研究的目的是评估社区健康教育者主导的 PAT+HEALTH 干预措施的有效性和实施情况，通过家访回答以下主要问题：
- 与未参加干预的女性相比，参与干预的女性从基线到 18 个月随访的体重变化是否会更大？
- 与对照组相比，干预组中的妇女和儿童是否会表现出更好的 CVH 促进生活方式行为？
研究参与者将完成基线调查并获取临床数据、实验室数据和身体测量数据。 参与者还将在出生时以及产后每 6 个月至 24 个月重复一次这些程序。 一旦被随机分配到干预组，参与者将完成 40 次每两周一次的 PAT+HEALTH 课程交付课程，每次持续约 60-90 分钟。
研究概览
研究类型
介入性
注册 (估计的)
1000
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
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Abuja、尼日利亚
- University of Abuja Teaching Hospital
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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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
•≥18岁，
- 怀孕14周以下的孕妇，
- 单胎妊娠，
- 体重指数 > 30 kg/m2
- 愿意参加ENHANCE CVH 2年，
- 计划在参与的初级医疗保健中心或阿布贾大学教学医院之一接受产前护理和分娩，以及
- 能够对参与研究给予知情同意，并了解她和她的孩子都将参与其中。
排除标准：
- 目前正在参加减肥计划，
- 无法参加步行计划，
- 活性物质滥用
- 使用已知会影响体重的药物治疗（例如皮质类固醇、抗精神病药），
- 计划在未来 2 年内搬迁，或
- 不愿意提供知情同意。
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：PAT+健康干预
随机分配到这一组的参与者将在产前和产后每两周接受 40 次 PAT+HEALTH 干预。
这些活动主要侧重于通过改变生活方式和行为以及对怀孕和心血管健康的额外支持和教育来促进母亲和儿童的心血管健康。
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该干预措施是对 PAT 课程和健康干预措施的改编，专为尼日利亚国情量身定制。
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无干预：控制
随机分配到对照组的参与者将不接受 PAT+HEALTH 干预，而仅接受标准的产前和产后护理。
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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 |
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母亲体重较基线的变化
大体时间：基线至产后 18 个月随访
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组间母亲体重从基线到 18 个月随访的变化差异（以公斤为单位）。
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基线至产后 18 个月随访
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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心血管健康评分的变化
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访，孕产妇心血管健康评分（范围从 0-100：Life's Essential 8）变化的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 烟草使用/接触
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访，烟草使用/暴露子评分（范围从 0-100：生命必需品 8）变化的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 饮食
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月的随访，饮食子评分（范围从 0-100：Life's Essential 8）变化的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 体力活动
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访，体力活动分项评分（范围从 0-100：Life's Essential 8）变化的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - BMI
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访，BMI 子评分（范围从 0-100：Life's Essential 8）变化的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 血压
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访的血压子评分变化（范围从 0-100：Life's Essential 8）的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 胆固醇
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访的胆固醇子评分变化（范围从 0-100：Life’s Essential 8）的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 血糖
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访的血糖子评分变化（范围从 0-100：Life's Essential 8）的组间差异。
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基线至产后 18 个月随访
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心血管健康评分的变化 - 睡眠
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月的随访，睡眠子评分（范围从 0-100：Life’s Essential 8）变化的组间差异。
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基线至产后 18 个月随访
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儿童 CVH 行为的变化 - 饮食
大体时间：出生至18个月
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通过家长报告的从出生到 18 个月的饮食来测量儿童心血管健康行为的组间差异。
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出生至18个月
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儿童 CVH 行为的变化 - 体力活动
大体时间：出生至18个月
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使用运动行为问卷 - 儿童开放版 (MBQ-C) 通过家长报告的从出生到 18 个月的活动来测量儿童心血管健康行为的组间差异
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出生至18个月
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儿童 CVH 行为的变化 - 睡眠
大体时间：出生至18个月
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使用婴儿睡眠简短问卷 - 修订版 (BISQ-R) 通过家长报告的从出生到 18 个月的睡眠来测量儿童心血管健康行为的组间差异
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出生至18个月
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孕产妇死亡率
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访的孕产妇综合死亡率的组间差异
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基线至产后 18 个月随访
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孕产妇发病率
大体时间：基线至产后 18 个月随访
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从基线到产后 18 个月随访的孕产妇发病率（定义为任何严重不良事件的发生）的组间差异。
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基线至产后 18 个月随访
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死产或自然流产
大体时间：出生时测量
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死产或自然流产的综合率在组间存在差异。
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出生时测量
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新生儿、婴儿和儿童死亡率
大体时间：出生至18个月
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从出生到 18 个月的新生儿、婴儿或儿童死亡率的综合率在组间存在差异。
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出生至18个月
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新生儿、婴儿和儿童发病率
大体时间：出生至18个月
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新生儿、婴儿或儿童发病率的组间差异（定义为从出生到 18 个月内发生任何严重不良事件）。
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出生至18个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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儿童身高体重
大体时间：出生、6个月、18个月
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6 个月和 18 个月时儿童身长别体重 z 评分的组间差异，根据出生时体重别身长 z 评分进行调整。
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出生、6个月、18个月
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儿童体重指数
大体时间：出生、6个月、18个月
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6 个月和 18 个月时儿童 BMI z 得分的组间差异，根据出生时体重身长 z 得分进行调整。
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出生、6个月、18个月
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父母的喂养行为
大体时间：6个月、12个月、18个月、24个月
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通过喂养管理儿童行为问卷 (FMCBQ) 测量父母的喂养行为
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6个月、12个月、18个月、24个月
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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：Dike B Ojji, MD、University of Abuja Teaching Hospital
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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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有用的网址
研究记录日期
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研究主要日期
学习开始 (实际的)
2025年6月23日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2028年8月1日
研究注册日期
首次提交
2024年12月16日
首先提交符合 QC 标准的
2025年1月13日
首次发布 (实际的)
2025年1月14日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R01HL168771 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
研究结束后，将按照 BioData Catalyst 的指南提供去识别化的数据。
将提供密码本。
IPD 共享时间框架
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提供给 BioData Catalyst 的数据将按照其标准完全去识别化。
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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