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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634593
• Other study ID #: F140825002
• Secondary ID: R03DK104010
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity

Intervention

Behavioral:
• Low glycemic load snacks
Intervention to replace standard night-time food and drinks with lower glycemic load options

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose concentrations measured by a glucose tolerance test.		5 weeks
Secondary	Fetal growth	Measure abdominal circumference of fetus by ultrasound	5 weeks
Secondary	Mean amplitude of glucose excursions	Measured with continuous glucose monitors	5 weeks