NCT03232762

Effects of Diet on Pregnancy Outcome and Child Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Refined 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.
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.

Timeline

• Start date: 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 across 1 country: United States