Effects of Diet on Pregnancy Outcome and Child Obesity

November 11, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diet A
high proportion of calories from refined grains as a carbohydrate source
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.
Active Comparator: Diet B
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in weight gain
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pre-Term Birth Rate
Time Frame: 6 Months
6 Months
Neonatal Weight
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Bruce Young, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-00694

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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