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.

Study Overview

• Status: Completed
• Conditions: Obesity; Glucose Intolerance
• Intervention / Treatment: Behavioral: Low glycemic load snacks

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Low glycemin load snacks; Low glycemic load snacks, consumed during specific times	Behavioral: Low glycemic load snacks; Intervention to replace standard night-time food and drinks with lower glycemic load options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in glucose concentrations measured by a glucose tolerance test.	5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Paula Chandler-Laney, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: nutrition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: F140825002; R03DK104010 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No