Birth Weight, Blood Pressure, Breast Feeding, Diet Modification, Hypertension, Obesity, Pre-Eclampsia, Pregnancy Related
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* All normal pregnant patients who will be more than three months from term
Exclusion criteria
* Illness making it a high risk pregnancy * Chronic renal disease * Malignancy * Congestive heart failure * Diabetes * Hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in weight gain | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Pre-Term Birth Rate | 6 Months |
| Neonatal Weight | 6 Months |
Countries
United States