A Low Glycemic Load Diet During Pregnancy in Overweight Women

Not Applicable

Completed

• Conditions: Overweight; Pregnancy
• Interventions: Behavioral: Low glycemic load; Behavioral: Low fat diet

• Registration Number: NCT00364403
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-15
• Study Start: 2007-02
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-27
• Last Update Posted: 2010-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low glycemic load	Low glycemic load diet
2	Low fat diet	Low fat diet

Primary Outcome Measures

Name	Time	Method
Birth weight as assessed by z-scores	At birth

Secondary Outcome Measures

Name	Time	Method
Maternal energy intake	During pregnancy
Maternal weight gain	During pregnancy
Maternal insulin resistance assessed by HOMA	During pregnancy
Maternal metabolic syndrome components	During pregnancy
Infant body composition (ponderal index, skinfold thickness)	At birth
Cord blood glucose	At birth
cord blood insulin	At birth
cord blood leptin	At birth

Trial Locations

Locations (2)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States