Effects of a Lifestyle Intervention on Gestational Diabetes Management

Not Applicable

Completed

• Conditions: Nutritional and Metabolic Disease; Type 2 Diabetes; Gestational Diabetes
• Interventions: Behavioral: Dietary Intervention

• Registration Number: NCT04861324
• Lead Sponsor: University of Nevada, Las Vegas

Brief Summary

The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

Detailed Description

Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Study Start: 2021-04-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• high risk for gestational diabetes
• willing to make lifestyle changes
• history of diabetes

Exclusion Criteria

• carrying more than one fetus
• history of chronic conditions except diabetes and hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fruit/veggie + postprandial physical activity	Dietary Intervention	Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery

Primary Outcome Measures

Name	Time	Method
Maternal gestational weight gain	12 weeks	Body weight
Maternal medication usage	12 weeks	Glucose-lowering medications
Maternal Lipids	12 weeks	LDL-cholesterol and triglycerides
Maternal glycemic control	12 weeks	Blood glycated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Maternal serum carotenoids	12 weeks	Carotenoids indicating fruit and vegetable consumption
Maternal inflammation	12 weeks	Adipokines, C-reactive protein

Trial Locations

Locations (1)

UNLV School of Medicine MFM clinic; 🇺🇸 Las Vegas, Nevada, United States