Effects of Diet on Pregnancy Outcome and Child Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Diet on Pregnancy Outcome and Child Obesity

Conditions
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Pregnancy Related, Diet Modification, Obesity, Hypertension, Pre-Eclampsia, Blood Pressure, Breast Feeding, Birth Weight

Intervention / Treatment
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* Dietary Supplement: Refined Grains
* Dietary Supplement: Whole Grains


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet A<br>high proportion of calories from refined grains as a carbohydrate source | Dietary Supplement: Refined Grains<br>* 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.<br>|
| Active Comparator: Diet B<br>a high proportion of calories from whole grains | Dietary Supplement: Whole Grains<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in weight gain |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Term Birth Rate |  | 6 Months | 
| Neonatal Weight |  | 6 Months |