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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Obesity
Glucose Intolerance

Treatments

Behavioral: Low glycemic load snacks

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02634593
F140825002
R03DK104010 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

16 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Control
No Intervention group
Description:
Control
Low glycemin load snacks
Active Comparator group
Description:
Low glycemic load snacks, consumed during specific times
Treatment:
Behavioral: Low glycemic load snacks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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