Pregnancy Clinical Trial
Official title:
Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Verified date | August 2010 |
Source | Children's Hospital Boston |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2 - Singleton pregnancy - Willing to consume the diets for duration of pregnancy - Participant to be at week 28 or less of pregnancy at baseline visit Exclusion Criteria: - Smoking during pregnancy - Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease) - Patients taking prescription medication known to affect body weight - Alcohol consumption during pregnancy - Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston - High level of physical activity |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Boston | Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birth weight as assessed by z-scores | At birth | No | |
Secondary | Maternal energy intake | During pregnancy | No | |
Secondary | Maternal weight gain | During pregnancy | No | |
Secondary | Maternal insulin resistance assessed by HOMA | During pregnancy | No | |
Secondary | Maternal metabolic syndrome components | During pregnancy | No | |
Secondary | Infant body composition (ponderal index, skinfold thickness) | At birth | No | |
Secondary | Cord blood glucose | At birth | No | |
Secondary | cord blood insulin | At birth | No | |
Secondary | cord blood leptin | At birth | No |
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