Healthy Diet for Healthy Moms and Babies

Study Overview
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Brief Summary
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The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.

Official Title
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Healthy Diet for Healthy Moms and Babies

Conditions
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Gestational Diabetes, Obesity, Pregnancy, High Risk

Intervention / Treatment
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* Dietary Supplement: Blueberry + soluble fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > or = 30, <20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes Exclusion Criteria: • Twin or multiple pregnancy Chronic pre-pregnancy conditions (CHD, cancer, diabetes) Gastrointestinal conditions Anemia Allergic to berries and fiber Vegetarian food habits or special diets Not proficient in English and/or unable to provide consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 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>Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care. | |
| Experimental: Dietary Intervention<br>Participants were given dietary blueberries (2 cups) and soluble fiber (12g). They also received nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care. | Dietary Supplement: Blueberry + soluble fiber<br>* Dietary frozen blueberries and soluble fiber for 20 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Maternal weight gain in lbs | 20 weeks | 
| Gestational glycemia | Maternal blood glucose and HbA1c as measures of glycemia | 20 weeks | 
| Maternal serum lipids | Conventional total, LDL-cholesterol and their particle size to describe lipid profiles | 20 weeks | 
| Maternal inflammation | C-reactive protein as a stable biomarker of inflammation | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal biomarkers of atherosclerosis | Serum cytokines measured as interleukins and adipokines | 20 weeks | 
| Maternal dietary intakes | Maternal intakes of energy intake and nutrients | 20 weeks |