Effects of Diet on Pregnancy Outcome and Child Obesity

NYU Langone Health

Status: Completed

Conditions: Breast Feeding; Pre-Eclampsia; Hypertension; Birth Weight; Pregnancy Related; Obesity; Diet Modification; Blood Pressure

Treatments: Dietary Supplement: Whole Grains; Dietary Supplement: Refined Grains

Study type: Interventional

Funder types: Other

Identifiers

NCT03232762

17-00694

Details and patient eligibility

About

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.

Full 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.

Enrollment: 303 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Diet A

Active Comparator group

Description:

high proportion of calories from refined grains as a carbohydrate source

Treatment:

Dietary Supplement: Refined Grains

Diet B

Active Comparator group

Description:

a high proportion of calories from whole grains

Treatment:

Dietary Supplement: Whole Grains