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OpenTrials
Completed

NCT Number: NCT03232762

Effects of Diet on Pregnancy Outcome and Child Obesity

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.

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Key information

Conditions

Pregnancy Related Behavior Birth Weight Blood Pressure Body Weight Breast Feeding Cardiovascular Diseases Diet Modification Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Refined Grains

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.

Whole grains

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.

Primary outcomes

  1. Differences in weight gain

    Time frame: 6 Months

Secondary outcomes

  1. Pre-Term Birth Rate

    Time frame: 6 Months

  2. Neonatal Weight

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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