Continuation of the nuMoM2b Heart Health Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,048
- 试验地点
- 28
- 主要终点
- Incidence of obesity
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventative strategies for women. The nuMoM2b Heart Health Study (nuMoM2b-HHS) has followed a demographically diverse cohort of women enrolled and richly phenotyped during their first pregnancy, with data and biospecimens prospectively collected for up to 7 years thereafter. The overarching scientific goal of this study is to define the relationship between adverse pregnancy outcomes (APOs) and CVD to optimize CVD prediction, prevention, and treatment strategies for women. Continued follow-up of this observational cohort, building on a foundation of existing high-quality data, biospecimens, and administrative structures with a robust framework for ancillary study development and implementation, provides a unique opportunity to address knowledge gaps regarding the early mechanisms and trajectory of CVD in women.
详细描述
The Continuation of nuMoM2b Heart Health Study (nuMoM2b-HHS2) will include prospectively collected longitudinal data on CVD risk factors and early clinical manifestations of CVD, the study's primary outcomes of interest. Measures completed during semiannual follow-ups will include 1) self-reported interval medical history, including medications and substance use; 2) interval pregnancy and postpartum history; 3) interval CVD events, conditions, and diagnostic and therapeutic procedures including CVD death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), peripheral vascular disease, kidney disease, hypertension, diabetes, hyperlipidemia, and associated hospitalizations and procedures.
During a study visit in years 3-7, the participant's blood pressure, pulse rate, weight, height, and body measurements will be recorded. During the visit, a fasting blood draw and clean-catch urine specimen will be collected. Aliquots of whole blood, plasma, serum, and urine will be stored at the biorepository; these will be analyzed for CVD measures of lipids, triglycerides, and glucose, among others. Measures of behavioral risk factors, including nutrition, physical activity, and stress will also be completed.
Ancillary studies will expand data collection during the follow-up contacts and in-person visit, and add to the planned contact schedule, to permit the effective targeting of knowledge gaps required to optimize predictive and preventative strategies. Some ancillary studies will only rely on extant data, while others will require de novo data collection during the planned follow-up contacts and/or study visits (or participation in additional study visits).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):
- •Completed one or more interval contacts during the nuMoM2b Heart Health Study.
- •Able to speak or read in English or Spanish.
排除标准
- •for nuMoM2b-HHS2 interval contact (telephone interview or web-based self-administered survey):
- •Withdrawal from study.
- •Inclusion Criteria for nuMoM2b-HHS2 study visit:
- •Completed one or more interval contacts during the nuMoM2b Heart Health Study.
- •At least 18 years of age.
- •Self-report of at least 3 months postpartum from any subsequent pregnancy.
- •Provision of signed informed consent for the HHS2 study visit.
- •Able to speak or read English or Spanish.
- •Exclusion Criteria for nuMoM2b-HHS2 study visit:
- •Current pregnancy.
- •Withdrawal from study.
结局指标
主要结局
Incidence of obesity
时间窗: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Measured BMI GE 30 kg/m\^2
Incidence of hypertension (130/80 mmHg)
时间窗: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Measured blood pressure \> 130/80 mmHg, use of antihypertensive medication, or self-report of a hypertension clinical diagnosis
Incidence of diabetes
时间窗: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Measured hemoglobin A1c GE 6.5%, fasting blood glucose GE 126 mg/dL, use of blood sugar lowering medication, or self-report of a diabetes clinical diagnosis
Incidence of metabolic syndrome
时间窗: Assessed during the HHS2 in-person visit, 8-16 years after the index pregnancy.
Per the American Heart Association standard definition: Any three of the following five - 1) waist circumference \> 35 inches (88 cm) for non-Asians and \> 31.5 inches (80 cm) for Asians; 2) triglycerides \> 150 mg/dL or medication treatment for high triglycerides; 3) high density lipoprotein (HDL) \< 50 mg/dL or medication treatment for low HDL; 4) a serum glucose ≥ 100 mg/dL or a diagnosis of diabetes mellitus; 5) systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, or medication treatment for hypertension.
次要结局
未报告次要终点
研究者
Becky McNeil
Senior Research Statistician
RTI International