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Effects of a Lifestyle Intervention on Gestational Diabetes Management

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ClinicalTrials.gov Identifier: NCT04861324
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Arpita Basu, University of Nevada, Las Vegas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Type 2 Diabetes Nutritional and Metabolic Disease Behavioral: Dietary Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Lifestyle Intervention on Gestational Diabetes Management
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Prenatal Care/Nutrition Education
Standard prenatal care with primary care physician with USDA-based federal guidelines
Experimental: Fruit/veggie + postprandial physical activity
Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery
 Behavioral: Dietary Intervention
Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females going through pregnancy and diagnosed with gestational diabetes
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861324


Contacts
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Contact: Arpita Basu, PhD 4056122414 arpita.basu@unlv.edu

Locations
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United States, Nevada
UNLV School of Medicine MFM clinic Recruiting
Las Vegas, Nevada, United States, 89154
Contact: Audrey Coffee    702-895-4328      
Sponsors and Collaborators
University of Nevada, Las Vegas
Investigators
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Principal Investigator: Arpita Basu, PhD University of Nevada at Las Vegas
More Information
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Responsible Party: Arpita Basu, Associate Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT04861324    
Other Study ID Numbers: 1610677
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Metabolic Diseases
 Glucose Metabolism Disorders
Endocrine System Diseases
Pregnancy Complications