NCT07165990尚未招募不适用
Produce Rx in High Risk Pregnant Mothers at Harris Health
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of participants with gestational diabetes mellitus (GDM)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women receiving care at Harris Health clinics
- •Medicaid eligible or receiving Medicaid
- •<=14 weeks gestation at the time of the first prenatal visit and study enrollment
- •meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age > 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level > 5.7 & < 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)
- •fall within the study delivery radius
排除标准
- •report existing or pregestational T2DM
- •have hemoglobin A1c>=7
- •are prescribed insulin therapy or metformin upon first screening
结局指标
主要结局
Number of participants with gestational diabetes mellitus (GDM)
时间窗: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)
Number of participants with gestational diabetes mellitus (GDM)
时间窗: 24-28 weeks gestational age (about 10-12 weeks after start of the intervention)
次要结局
- Number of participants with hypertensive disorders of pregnancy(24-28 weeks gestational age (about 10 weeks after start of the intervention))
- Number of infants with macrosomia at birth(at the time of birth)
- Number of infants with pre-term birth(at the time of birth)
- Number of infants born via C-section(at the time of birth)
- Change in Hemoglobin A1c levels(at the time of the first prenatal visit, at the time of birth)
- Change in Hemoglobin A1c levels(at the time of the first prenatal visit, at the time of birth)
- Number of infants with pre-term birth(at the time of birth)
- Number of infants born via C-section(at the time of birth)
- Number of participants with hypertensive disorders of pregnancy(24-28 weeks gestational age (about 10 weeks after start of the intervention))
- Number of infants with macrosomia at birth(at the time of birth)
研究者
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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