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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet A | Active Comparator | high proportion of calories from refined grains as a carbohydrate source |
|
| Diet B | Active Comparator | a high proportion of calories from whole grains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refined Grains | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in weight gain | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Term Birth Rate | 6 Months | |
| Neonatal Weight | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
All will be pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Young, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35525865 | Derived | Sun H, Yamada P, Paetow A, Chan M, Arslan A, Landberg R, Dominguez-Bello MG, Young BK. A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy. Sci Rep. 2022 May 7;12(1):7509. doi: 10.1038/s41598-022-11571-4. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D011225 | Pre-Eclampsia |
| D001942 | Breast Feeding |
| D001724 | Birth Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067348 | Whole Grains |
| ID | Term |
|---|---|
| D002523 | Edible Grain |
| D018556 | Crops, Agricultural |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Whole Grains | Dietary Supplement | 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. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010829 |
| Physiological Phenomena |
| D012639 | Seeds |
| D019602 | Food and Beverages |