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

Not Applicable

Completed

• Conditions: Glucose Intolerance; Obesity
• Interventions: Behavioral: Low glycemic load snacks

• Registration Number: NCT02634593
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Study Start: 2016-06
• Primary Completion: 2018-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low glycemin load snacks	Low glycemic load snacks	Low glycemic load snacks, consumed during specific times

Primary Outcome Measures

Name	Time	Method
Change in glucose concentrations measured by a glucose tolerance test.	5 weeks

Secondary Outcome Measures

Name	Time	Method
Mean amplitude of glucose excursions	5 weeks	Measured with continuous glucose monitors
Fetal growth	5 weeks	Measure abdominal circumference of fetus by ultrasound

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States