Effects of Diet on Pregnancy Outcome and Child Obesity

NCT03232762 — Not applicable, Completed, 303 participants, NYU Langone Health

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Registry	NCT03232762
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	303 (Actual)
Sponsor	NYU Langone Health (Other)
Conditions	Pregnancy Related, Diet Modification, Obesity, Hypertension, Pre-Eclampsia, Blood Pressure, Breast Feeding, Birth Weight
Interventions	Refined Grains, Whole Grains (Dietary supplement)
Dates	start 2017-10-03, primary completion 2019-08-22, completion 2019-08-22, first posted 2017-07-28, last updated 2019-11-13
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Diet A	Active comparator	Dietary Supplement: Refined Grains	high proportion of calories from refined grains as a carbohydrate source
Diet B	Active comparator	Dietary Supplement: Whole Grains	a high proportion of calories from whole grains

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.
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.

+Outcome measures

Primary outcomes

Differences in weight gain [6 Months]

Secondary outcomes

Pre-Term Birth Rate [6 Months]
Neonatal Weight [6 Months]

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
New York University School of Medicine	New York, New York	United States

+Publications

Results publication: 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. PMID 35525865

+Investigators

Bruce Young, MD, Principal investigator, NYU Langone Health

My Notes

Public

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