Effects of a Lifestyle Intervention on Gestational Diabetes Management

Type 2 Diabetes Clinical Trial

Official title:

Effects of a Lifestyle Intervention on Gestational Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861324
• Other study ID #: 1610677
• Status: Completed
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Metabolic Diseases
• Nutritional and Metabolic Disease
• Type 2 Diabetes

Intervention

Behavioral:
• Dietary Intervention
Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity

Locations

Country	Name	City	State
United States	UNLV School of Medicine MFM clinic	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal glycemic control	Blood glycated hemoglobin	12 weeks
Primary	Maternal gestational weight gain	Body weight	12 weeks
Primary	Maternal medication usage	Glucose-lowering medications	12 weeks
Primary	Maternal Lipids	LDL-cholesterol and triglycerides	12 weeks
Secondary	Maternal inflammation	Adipokines, C-reactive protein	12 weeks
Secondary	Maternal serum carotenoids	Carotenoids indicating fruit and vegetable consumption	12 weeks