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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
303
In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
New York University School of Medicine
New York, New York, United States
Differences in weight gain
Time frame: 6 Months
Pre-Term Birth Rate
Time frame: 6 Months
Neonatal Weight
Time frame: 6 Months
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