Effects of Diet on Pregnancy Outcome and Child Obesity

Not Applicable

Completed

• Conditions: Hypertension; Pregnancy Related; Obesity; Blood Pressure; Breast Feeding; Diet Modification; Pre-Eclampsia; Birth Weight
• Interventions: Dietary Supplement: Whole Grains; Dietary Supplement: Refined Grains

• Registration Number: NCT03232762
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2017-10-03
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 303

Inclusion Criteria

• All normal pregnant patients who will be more than three months from term

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Exclusion Criteria

• Illness making it a high risk pregnancy
• Chronic renal disease
• Malignancy
• Congestive heart failure
• Diabetes
• Hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet B	Whole Grains	a high proportion of calories from whole grains
Diet A	Refined Grains	high proportion of calories from refined grains as a carbohydrate source

Primary Outcome Measures

Name	Time	Method
Differences in weight gain	6 Months

Secondary Outcome Measures

Name	Time	Method
Pre-Term Birth Rate	6 Months
Neonatal Weight	6 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States