Effects of Diet on Pregnancy Outcome and Child Obesity

NCT ID: NCT03232762

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2019-08-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diet A

high proportion of calories from refined grains as a carbohydrate source

Group Type: ACTIVE_COMPARATOR

Refined Grains

Intervention Type: 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.

Diet B

a high proportion of calories from whole grains

Group Type: ACTIVE_COMPARATOR

Whole Grains

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Young, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35525865 (View on PubMed)

Other Identifiers

17-00694

Identifier Type: -

Identifier Source: org_study_id