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Clinical Trials/NCT01628835
NCT01628835CompletedNot Applicable

Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.

Children's Hospital of Fudan University2 sites in 1 country400 target enrollmentStarted: June 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
2
Primary Endpoint
Maternal weight gain

Study Overview

Brief Summary

The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.

Detailed Description

Overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. Recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. The hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth.

The current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. Four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. Glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. The effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. For discrete traits, such as incidence of gestational diabetes and gestational hypertension, Person's chi-square tests were used. For continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. The study expects that long-term low GI diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maternal weight gain

Time Frame: measured before delivery

measured before delivery (minus pre-conceptual body weight)

Cord blood C-peptide

Time Frame: at delivery

Incidence of gestational diabetes

Time Frame: during pregnancy

from 1st antenatal visit to delivery

Incidence of macrosomia

Time Frame: at delivery

birth weight \>= 4000g

Maternal insulin resistance

Time Frame: During pregnancy

Secondary Outcomes

  • Incidence of gestational hypertension(during pregnancy)
  • cesarean(at delivery)
  • Mean infant birth weight(at delivery)
  • Incidence of premature delivery(at delivery)
  • head circumference(at delivery)
  • Mean gestational age(at delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weili Yan

Professor, Director

Children's Hospital of Fudan University

Study Sites (2)

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