Effects of Diet on Pregnancy Outcome and Child Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Differences in weight gain
研究概览
简要总结
The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.
详细描述
There will be randomized sequential assignment of pregnant women at the initial clinic visit to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and Diet B, a high proportion of calories from whole grains. Random number assignment is impractical for counseling purposes and blinding not possible. Therefore, randomization by diet assignment by day of initial visit via random number was chosen. If the random number is odd Diet A would be selected, if the random number is even Diet B will be selected for that day.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All normal pregnant patients who will be more than three months from term
排除标准
- •Illness making it a high risk pregnancy
- •Chronic renal disease
- •Malignancy
- •Congestive heart failure
- •Hypertension
结局指标
主要结局
Differences in weight gain
时间窗: 6 Months
次要结局
- Pre-Term Birth Rate(6 Months)
- Neonatal Weight(6 Months)