Effects of Diet on Pregnancy Outcome and Child Obesity

Obesity Clinical Trial

Official title:

Effects of Diet on Pregnancy Outcome and Child Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232762
• Other study ID #: 17-00694
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: August 22, 2019

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in weight gain		6 Months
Secondary	Pre-Term Birth Rate		6 Months
Secondary	Neonatal Weight		6 Months