ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health (ENHANCE-CVH)

项目摘要 尼日利亚是产妇发病率和死亡率负担最重的国家之一，估计有528人。 (95%不确定区间：351815)2019年每100,000名新生儿中的孕产妇死亡(全球平均水平：152/10万 100,000)。这一比率远远超过联合国可持续发展目标3.1：每10万人中有70人死于孕产妇 到2030年出生的活产儿。尼日利亚的非传染性疾病负担也很大，而且还在不断增加，包括 超重/肥胖、高血压、糖尿病和心血管疾病。不健康的变化 饮食模式和体力活动助长了这些不利趋势，特别是在关键的生命阶段， 例如围产期、婴儿期和儿童期。改善孕产妇健康行为及后续行动 孕产妇心血管健康是改善家庭心血管健康的中心战略，以钝化和 最终扭转尼日利亚不断增加的非传染性疾病负担。尼日利亚的国家多部门 预防和控制非传染性疾病行动计划和国家任务转移和 共享政策是新的相关政策框架，将被用来改善代际 在这项提案中，尼日利亚人的心血管健康。这项研究的目的是测试有效性和 实施适应性健康(在家教授健康饮食和积极生活)干预 1,000名肥胖孕妇的代际心血管健康状况 通过在40名尼日利亚初选儿童中实施的2型混合整群随机(1：1)试验进行的产前阶段 医疗保健中心。使用报告适应和修改框架--扩展，健康 干预及其实施将从循证、家长为本转变为教师之家 来自美国的访问模型已经被华盛顿大学的研究人员使用和验证，包括 在美国国立卫生研究院资助的RICH财团。我们将使用包括认证培训师在内的培训师培训模式 对社区卫生推广工作者和社区护士健康教育者进行深入培训。初级阶段 有效性结果将是孕妇体重从基线到18个月随访的变化，&gt；85% 检测两组间2.5千克差异的功率。次要效果结果包括变化 在产妇心血管健康方面。探索性结果包括婴儿和儿童生长发育的变化。安全问题 将收集数据。Re-AIM将指导定量和定性执行成果评估，以及 REACH将是主要的实施成果，其中50%的目标是招募小学女性 受教育程度或更低。我们在华盛顿大学、阿布贾大学的美国和尼日利亚调查团队， 和纽约大学已经合作了5年，并得到了NIH 5笔有效拨款的支持。我们有很强的 来自尼日利亚主要利益攸关方的支持，包括地方、州和国家各级的支持。因此，我们的建议是 高度可行、高效、有可能成功、响应这一融资机会，与NIH和GACD保持一致 优先事项，并将通过嵌入能力建设对我们的团队成员互惠互利。

PROJECT ABSTRACT Nigeria has among the highest burdens of maternal morbidity and mortality, including an estimated 528 (95% uncertainty intervals: 351, 815) maternal deaths per 100,000 lives birth in 2019 (global average: 152 per 100,000). This rate far exceeds the UN Sustainable Development Target 3.1: <70 maternal deaths per 100,000 live births by 2030. Nigeria also has a large and rising burden of noncommunicable diseases, including overweight/obesity, hypertension, diabetes mellitus, and cardiovascular diseases. Unhealthy changes in dietary patterns and physical activity contribute to these adverse trends, especially during critical life stages, such as the peripartum period, infancy, and childhood. Improving maternal health behaviors and subsequent maternal cardiovascular health is a central strategy toward improving family cardiovascular health to blunt and eventually reverse the rising burden of noncommunicable diseases in Nigeria. Nigeria's National Multisectoral Action Plan for the Prevention and Control of Noncommunicable Diseases and National Task Shifting and Sharing Policy are new and relevant policy frameworks that will be leveraged to improve intergenerational cardiovascular health among Nigerians in this proposal. The objective of this study is to test effectiveness and implementation of an adapted HEALTH (Healthy Eating Active Living Taught at Home) intervention on intergenerational cardiovascular health among 1,000 pregnant women with obesity recruited during the antenatal period through a type 2 hybrid cluster randomized (1:1) trial implemented in 40 Nigerian primary healthcare centers. Using the Framework for Reporting Adaptations and Modifications-Expanded, the HEALTH intervention and its implementation will be adapted from the evidence-based, Parents as Teachers home visiting model from the US that has been used and validated by Washington University researchers, including in the NIH-funded ENRICH consortium. We will use a train-the-trainer model including certified trainers to step down training to community health extension workers and community nurse health educators. The primary effectiveness outcome will be change in maternal body weight from baseline to 18-month follow-up with >85% power to detect a between-group of difference of 2.5 kg. Secondary effectiveness outcomes include changes in maternal cardiovascular health. Exploratory outcomes include changes in infant and child growth. Safety data will be collected. RE-AIM will guide quantitative and qualitative implementation outcome assessment, and reach will be the primary implementation outcome with a >50% target of recruiting women with primary school education or less. Our team of US and Nigerian investigators at Washington University, University of Abuja, and New York University have collaborated for >5 years with support from 5 active NIH grants. We have strong support from key Nigerian stakeholders, including at local, state, and national levels. Thus, our proposal is highly feasible, efficient, likely to succeed, responsive to this funding opportunity, aligned with NIH and GACD priorities, and will be mutually beneficial to our team members through embedded capacity building.