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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02634593
Enrollment
30
Registered
2015-12-18
Start date
2016-06-30
Completion date
2019-01-31
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Intolerance, Obesity

Keywords

nutrition

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.

Interventions

BEHAVIORALLow glycemic load snacks

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

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in glucose concentrations measured by a glucose tolerance test.5 weeks

Secondary

MeasureTime frameDescription
Fetal growth5 weeksMeasure abdominal circumference of fetus by ultrasound
Mean amplitude of glucose excursions5 weeksMeasured with continuous glucose monitors

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026