Effects of a Lifestyle Intervention on Gestational Diabetes Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Lifestyle Intervention on Gestational Diabetes Management

Conditions
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Gestational Diabetes, Type 2 Diabetes, Nutritional and Metabolic Disease

Intervention / Treatment
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* Behavioral: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Prenatal Care/Nutrition Education<br>Standard prenatal care with primary care physician with USDA-based federal guidelines | |
| Experimental: Fruit/veggie + postprandial physical activity<br>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<br>* Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal glycemic control | Blood glycated hemoglobin | 12 weeks | 
| Maternal gestational weight gain | Body weight | 12 weeks | 
| Maternal medication usage | Glucose-lowering medications | 12 weeks | 
| Maternal Lipids | LDL-cholesterol and triglycerides | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal inflammation | Adipokines, C-reactive protein | 12 weeks | 
| Maternal serum carotenoids | Carotenoids indicating fruit and vegetable consumption | 12 weeks |