Bump to Baby Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Birth Outcome Questionnaire
研究概览
简要总结
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.
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
- Single (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
- 是
入选标准
- •18 - 40 years old
- •BMI > 30 and/or history of gestational diabetes mellitus
- •Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
- •Newborns of current participants
排除标准
- •Diabetes (types 1 and 2)
- •History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
- •Known fetal anomaly
- •History of eating disorders
- •Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
- •Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco
结局指标
主要结局
Birth Outcome Questionnaire
时间窗: 24 months
Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.
次要结局
未报告次要终点
研究者
Kai Ling Kong
Principal Investigator
State University of New York at Buffalo