Gestational Diabetes, Nutritional and Metabolic Disease, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALDietary Intervention
Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal glycemic control | 12 weeks | Blood glycated hemoglobin |
| Maternal gestational weight gain | 12 weeks | Body weight |
| Maternal medication usage | 12 weeks | Glucose-lowering medications |
| Maternal Lipids | 12 weeks | LDL-cholesterol and triglycerides |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal inflammation | 12 weeks | Adipokines, C-reactive protein |
| Maternal serum carotenoids | 12 weeks | Carotenoids indicating fruit and vegetable consumption |
Countries
United States
Outcome results
None listed