Effects of a Lifestyle Intervention on Gestational Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Maternal Lipids
研究概览
简要总结
The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.
详细描述
Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •high risk for gestational diabetes
- •willing to make lifestyle changes
- •history of diabetes
排除标准
- •carrying more than one fetus
- •history of chronic conditions except diabetes and hypertension
结局指标
主要结局
Maternal Lipids
时间窗: 12 weeks
LDL-cholesterol and triglycerides
Maternal gestational weight gain
时间窗: 12 weeks
Body weight
Maternal medication usage
时间窗: 12 weeks
Glucose-lowering medications
Maternal glycemic control
时间窗: 12 weeks
Blood glycated hemoglobin
次要结局
- Maternal serum carotenoids(12 weeks)
- Maternal inflammation(12 weeks)
研究者
Arpita Basu
Associate Professor
University of Nevada, Las Vegas