Back to resultsEffects of a Lifestyle Intervention on Gestational Diabetes Management
Primary Purpose
Gestational Diabetes, Type 2 Diabetes, Nutritional and Metabolic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes
Eligibility 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
Sites / Locations
- UNLV School of Medicine MFM clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Prenatal Care/Nutrition Education
Fruit/veggie + postprandial physical activity
Arm Description
Standard prenatal care with primary care physician with USDA-based federal guidelines
Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery
Outcomes
Primary Outcome Measures
Maternal glycemic control
Blood glycated hemoglobin
Maternal gestational weight gain
Body weight
Maternal medication usage
Glucose-lowering medications
Maternal Lipids
LDL-cholesterol and triglycerides
Secondary Outcome Measures
Maternal inflammation
Adipokines, C-reactive protein
Maternal serum carotenoids
Carotenoids indicating fruit and vegetable consumption
Full Information
NCT ID
NCT04861324
First Posted
April 22, 2021
Last Updated
February 16, 2023
Sponsor
University of Nevada, Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT04861324
Brief Title
Effects of a Lifestyle Intervention on Gestational Diabetes Management
Official Title
Effects of a Lifestyle Intervention on Gestational Diabetes Management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Type 2 Diabetes, Nutritional and Metabolic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prenatal Care/Nutrition Education
Arm Type
No Intervention
Arm Description
Standard prenatal care with primary care physician with USDA-based federal guidelines
Arm Title
Fruit/veggie + postprandial physical activity
Arm Type
Experimental
Arm Description
Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention Description
Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity
Primary Outcome Measure Information:
Title
Maternal glycemic control
Description
Blood glycated hemoglobin
Time Frame
12 weeks
Title
Maternal gestational weight gain
Description
Body weight
Time Frame
12 weeks
Title
Maternal medication usage
Description
Glucose-lowering medications
Time Frame
12 weeks
Title
Maternal Lipids
Description
LDL-cholesterol and triglycerides
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maternal inflammation
Description
Adipokines, C-reactive protein
Time Frame
12 weeks
Title
Maternal serum carotenoids
Description
Carotenoids indicating fruit and vegetable consumption
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females going through pregnancy and diagnosed with gestational diabetes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, PhD
Organizational Affiliation
University of Nevada at Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNLV School of Medicine MFM clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of a Lifestyle Intervention on Gestational Diabetes Management
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