Low Glycemic Index (GI) Diet Management for Pregnant Woman With Overweight

Not Applicable

Completed

• Conditions: Pregnant Women; Overweight
• Interventions: Behavioral: Low dietary glycemic index diet; Behavioral: National recommendation diet

• Registration Number: NCT01628835
• Lead Sponsor: Children's Hospital of Fudan University

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 Timeline

• Study First Submitted: 2012-05-10
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dietary glycemic index diet	Low dietary glycemic index diet	Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided.
National recommendation diet	National recommendation diet	Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information

Primary Outcome Measures

Name	Time	Method
Maternal weight gain	measured before delivery	measured before delivery (minus pre-conceptual body weight)
Cord blood C-peptide	at delivery
Incidence of gestational diabetes	during pregnancy	from 1st antenatal visit to delivery
Incidence of macrosomia	at delivery	birth weight \>= 4000g
Maternal insulin resistance	During pregnancy

Secondary Outcome Measures

Name	Time	Method
Incidence of gestational hypertension	during pregnancy	proportion of patients with SBP/SBP\>=140/90 for 3 visits
cesarean	at delivery
Mean infant birth weight	at delivery
Incidence of premature delivery	at delivery	gestational age \<37 week at delivery
head circumference	at delivery
Mean gestational age	at delivery

Trial Locations

Locations (2)

Kunshan Maternal and Child Health Care Hospital; 🇨🇳 Kunshan city, Jiangsu, China

International Peace Maternity and Child Care Centers of Communications University; 🇨🇳 Shanghai, China