Effects of Diet on Pregnancy Outcome and Child Obesity
Primary Purpose
Pregnancy Related, Diet Modification, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Refined Grains
Whole Grains
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Related
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Diet A
Diet B
Arm Description
high proportion of calories from refined grains as a carbohydrate source
a high proportion of calories from whole grains
Outcomes
Primary Outcome Measures
Differences in weight gain
Secondary Outcome Measures
Pre-Term Birth Rate
Neonatal Weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232762
Brief Title
Effects of Diet on Pregnancy Outcome and Child Obesity
Official Title
Effects of Diet on Pregnancy Outcome and Child Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Diet Modification, Obesity, Hypertension, Pre-Eclampsia, Blood Pressure, Breast Feeding, Birth Weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet A
Arm Type
Active Comparator
Arm Description
high proportion of calories from refined grains as a carbohydrate source
Arm Title
Diet B
Arm Type
Active Comparator
Arm Description
a high proportion of calories from whole grains
Intervention Type
Dietary Supplement
Intervention Name(s)
Refined Grains
Intervention Description
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
Intervention Name(s)
Whole Grains
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in weight gain
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Pre-Term Birth Rate
Time Frame
6 Months
Title
Neonatal Weight
Time Frame
6 Months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All will be pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Young, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35525865
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Diet on Pregnancy Outcome and Child Obesity
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