Effects of Diet on Pregnancy Outcome and Child Obesity
1 other identifier
interventional
303
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedNovember 13, 2019
November 1, 2019
1.9 years
July 25, 2017
November 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in weight gain
6 Months
Secondary Outcomes (2)
Pre-Term Birth Rate
6 Months
Neonatal Weight
6 Months
Study Arms (2)
Diet A
ACTIVE COMPARATORhigh proportion of calories from refined grains as a carbohydrate source
Diet B
ACTIVE COMPARATORa high proportion of calories from whole grains
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- All normal pregnant patients who will be more than three months from term
You may not qualify if:
- Illness making it a high risk pregnancy
- Chronic renal disease
- Malignancy
- Congestive heart failure
- Diabetes
- Hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Related Publications (1)
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.
PMID: 35525865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Young, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2017
First Posted
July 28, 2017
Study Start
October 3, 2017
Primary Completion
August 22, 2019
Study Completion
August 22, 2019
Last Updated
November 13, 2019
Record last verified: 2019-11