Skip to main content
OpenTrials
Completed

NCT Number: NCT02634593

The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy

Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child. We hypothesize that women who replace their usual night-time foods and drinks with lower glycemic load options will have more stable night-time glucose and lower glucose following an oral glucose load. This intervention will be assessed in a cohort of African American women of low income, who were obese at their first prenatal care visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • African American race
  • Healthy, singleton pregnancy
  • ≤ 28 weeks' gestation at enrollment
  • BMI of 30.0 - 45.9 kg/m2 at first prenatal visit
  • Reports regular food consumption after 8pm at night that is not attributable to work schedule or other constraints.

Exclusion criteria

  • pre-gestation or gestational diabetes
  • current smoker
  • presence of any medical condition or the use of any medication known to affect fetal growth
  • previous delivery of a small-for-gestational age infant (<10th percentile)
  • previous delivery of a pre-term infant (<36.0 weeks' gestation)
  • inability to communicate in both verbal and written English
  • unwilling or unable to consume study-provided foods.

Treatment and study plan

Low glycemic load snacks

Behavioral

Intervention to replace standard night-time food and drinks with lower glycemic load options

Primary outcomes

  1. Change in glucose concentrations measured by a glucose tolerance test.

    Time frame: 5 weeks

Secondary outcomes

  1. Fetal growth

    Time frame: 5 weeks

    Measure abdominal circumference of fetus by ultrasound

  2. Mean amplitude of glucose excursions

    Time frame: 5 weeks

    Measured with continuous glucose monitors

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 18, 2015
Registry last updated
Mar 25, 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.

Published trials that share one or more normalized conditions with this study.