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Effects of Diet on Pregnancy Outcome and Child Obesity

Effects of Diet on Pregnancy Outcome and Child Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03232762
Enrollment
303
Registered
2017-07-28
Start date
2017-10-03
Completion date
2019-08-22
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTRefined 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_SUPPLEMENTWhole 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Differences in weight gain6 Months

Secondary

MeasureTime frame
Pre-Term Birth Rate6 Months
Neonatal Weight6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026