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

Primary Purpose

Glucose Intolerance, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low glycemic load snacks
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance focused on measuring nutrition

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Low glycemin load snacks

Arm Description

Control

Low glycemic load snacks, consumed during specific times

Outcomes

Primary Outcome Measures

Change in glucose concentrations measured by a glucose tolerance test.

Secondary Outcome Measures

Fetal growth
Measure abdominal circumference of fetus by ultrasound
Mean amplitude of glucose excursions
Measured with continuous glucose monitors

Full Information

First Posted
December 10, 2015
Last Updated
March 21, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02634593
Brief Title
The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy
Official Title
The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Obesity
Keywords
nutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Arm Title
Low glycemin load snacks
Arm Type
Active Comparator
Arm Description
Low glycemic load snacks, consumed during specific times
Intervention Type
Behavioral
Intervention Name(s)
Low glycemic load snacks
Intervention Description
Intervention to replace standard night-time food and drinks with lower glycemic load options
Primary Outcome Measure Information:
Title
Change in glucose concentrations measured by a glucose tolerance test.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Fetal growth
Description
Measure abdominal circumference of fetus by ultrasound
Time Frame
5 weeks
Title
Mean amplitude of glucose excursions
Description
Measured with continuous glucose monitors
Time Frame
5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Chandler-Laney, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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