Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.
详细描述
Preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. Preeclampsia disproportionately burdens ethnic minority women, especially African American women when compared to non-Hispanic white women. Once diagnosed with preeclampsia, African women are 3 times more likely to die of preeclampsia compared to their white counterparts. Evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. However, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. This proposal is designed to address this crucial gap by testing feasibility (Aim 1), acceptability (Aim 1) and efficacy (Aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city African American women. The intervention will be delivered via a randomized control trial design (N=100), with 6 monthly group sessions conducted in the second and third trimesters. The overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •self-report as African-American/Non-Hispanic black
- •residence in inner-city Milwaukee
- •nulliparity
- •gestational age at enrollment <=16 weeks
- •able and willing to give informed consent
排除标准
- •not able to communicate in English
- •major fetal anomaly
- •psychiatric illness that precludes group participation
结局指标
主要结局
Retention
时间窗: Post intervention measured at the completion of the last study visit, 3 years
Retention will be measured by session attendance rates.
Systolic and diastolic blood pressure: 6 Weeks Postpartum
时间窗: At 6 weeks postpartum visit
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
Systolic and diastolic blood pressure: Post Intervention
时间窗: Post intervention/at the last study visit, up to 40 weeks
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
次要结局
- Preeclampsia(At the 6 weeks postpartum visit through patient interview, confirmed with medical record review)
研究者
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin