An interventional study of Refined Grains and Whole Grains in Pregnancy Related, Diet Modification and Obesity, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.
This study's enrollment of 303 is above the median of 120 across 169 interventional studies indexed under Eclampsia.
Browse Eclampsia studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
high proportion of calories from refined grains as a carbohydrate source
Dietary Supplement: Refined Grains
a high proportion of calories from whole grains
Dietary Supplement: Whole Grains
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.
Differences in weight gain
Time frame: 6 Months
Pre-Term Birth Rate
Time frame: 6 Months
Neonatal Weight
Time frame: 6 Months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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