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Completed

NCT Number: NCT04861324

Effects of a Lifestyle Intervention on Gestational Diabetes Management

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Disease Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNLV School of Medicine MFM clinic

Las Vegas, Nevada, 89154, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity

Primary outcomes

  1. Maternal glycemic control

    Time frame: 12 weeks

    Blood glycated hemoglobin

  2. Maternal gestational weight gain

    Time frame: 12 weeks

    Body weight

  3. Maternal medication usage

    Time frame: 12 weeks

    Glucose-lowering medications

  4. Maternal Lipids

    Time frame: 12 weeks

    LDL-cholesterol and triglycerides

Secondary outcomes

  1. Maternal inflammation

    Time frame: 12 weeks

    Adipokines, C-reactive protein

  2. Maternal serum carotenoids

    Time frame: 12 weeks

    Carotenoids indicating fruit and vegetable consumption

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 27, 2021
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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