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Clinical Trials/NCT00364403
NCT00364403CompletedNot Applicable

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

Boston Children's Hospital2 sites in 1 country60 target enrollmentStarted: February 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Birth weight as assessed by z-scores
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Low glycemic load diet

Intervention: Low glycemic load (Behavioral)

2

Active Comparator

Low fat diet

Intervention: Low fat diet (Behavioral)

Outcomes

Primary Outcomes

Birth weight as assessed by z-scores

Time Frame: At birth

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (2)

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