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

NCT02634593 | Completed

• 2 other identifiers: F140825002R03DK104010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Intolerance; Obesity

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

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

  5 weeks

Secondary Outcomes (2)

• Fetal growth

  5 weeks

• Mean amplitude of glucose excursions

  5 weeks

Study Arms (2)

Control

NO INTERVENTION

Control

Low glycemin load snacks

ACTIVE COMPARATOR

Low glycemic load snacks, consumed during specific times

Behavioral: Low glycemic load snacks

Interventions

Low glycemic load snacks BEHAVIORAL

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

Low glycemin load snacks

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paula Chandler-Laney, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 18, 2015
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)