A Low Glycemic Load Diet During Pregnancy in Overweight Women

Pregnancy Clinical Trial

Official title:

Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364403
• Other study ID #: R03DK073335
• Secondary ID: R03DK073335
• Status: Completed
• Phase: N/A
• First received: August 14, 2006
• Last updated: August 27, 2010
• Start date: February 2007
• Est. completion date: February 2010

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Pregnancy

Intervention

Behavioral:
• Low glycemic load
Provision of foods and dietary counseling to promote a low glycemic load diet
• Low fat diet
Provision of foods and dietary counseling to promote a low fat diet

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

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