A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Fasting Glucose
研究概览
简要总结
The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.
详细描述
This is a randomized controlled parallel-group trial with two arms. Potential subjects will be identified from the OB Clinics at UI health systems, the University of Illinois at Chicago. After baseline assessments, the subjects will be randomized to the attention control arm (Birth-Prep) or BETTER intervention.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American pregnant woman.
- •Women between 16 and 22 GWs.
- •Overweight or obese - pregravid Body Mass Index >25.0 kg/m
- •Singleton gestation.
- •Established prenatal care at The University of Illinois Hospital & Health Sciences.
- •System Obstetric (UIHHSS' OB) clinics. Able to understand, speak and write in English.
排除标准
- •Multiple gestations.
- •Night-shift work.
- •Diagnosed sleep disorders.
- •Known fetal chromosomal or anatomical abnormalities.
- •Diagnosed mood disorders.
- •Gestational diabetes in early pregnancy.
- •Glycated Hemoglobin (HbA1c) ≥ 6.5%.
- •Hypoglycemic medications.
- •Stimulant medication or taking a sleeping aid.
- •Active drug abuse/excessive alcohol intake.
研究组 & 干预措施
Intervention arm
Sleep hygiene practices and cognitive-behavioral principles
干预措施: Better (Behavioral)
Attention control
Training about pregnancy issues
干预措施: Birth Prep (Behavioral)
结局指标
主要结局
Fasting Glucose
时间窗: 28-32 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
Fasting Glucose at baseline
时间窗: 16-22 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
次要结局
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline(16-22 Gestational Weeks)
- Glucose Area Under the Curve at baseline(16-22 Gestational Weeks)
- Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"(16-22 Gestational Weeks)
- Sleep Quality - Self-reported of sleep quality(34-36 Gestational Weeks)
- Glucose Area Under the Curve(34-36 Gestational Weeks)
- Sleep duration and sleep timing - Subjective and Objective Assessment(34-36 Gestational Weeks)
- Medical Records Extraction Form("post delivery, up to 3 months post intervention")
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(28-32 Gestational Weeks)
- Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"(16-22 Gestational Weeks)
研究者
Bilgay Izci Balserak
Associate Professor
University of Illinois at Chicago