Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Low Glycemic Index Diet Management for Overweight Pregnant Women (LGIDMOPW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Fudan University
Sponsor:
Collaborators:
Kunshan City Maternal and Child Health
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Weili Yan, Fudan University
ClinicalTrials.gov Identifier:
NCT01628835
First received: May 10, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Overweight Women at Pregnancy
Behavioral: Low glycemic diet counseling
Behavioral: Standard diet counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Maternal insulin [ Time Frame: from the randomization (<=12weeks gestation) to delivery (38-42 weeks gestation), an expected average of 25 weeks ] [ Designated as safety issue: No ]
    measured at first prenatal visit and last visit before delivery

  • Cord blood C-peptide [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    collect cord blood, seperate serum, and stored at -20 centigrade.

  • Incidence of gestational diabetes [ Time Frame: from the randomization(<=12weeks gestation) to delivery (38-42 weeks gestation), an expected average of 25 weeks ] [ Designated as safety issue: No ]
    Proportion of women with newly incident diabetes during pregnancy

  • macrosomia [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Baby weight at delivery in grams is equal to or greater than 4000g.


Secondary Outcome Measures:
  • Incidence of gestational hypertension [ Time Frame: from the randomization(<=12weeks gestation) to delivery (38-42 weeks gestation), an expected average of 25 weeks ] [ Designated as safety issue: No ]
    Proportion of women with newly incident hypertension during pregnancy. Hypertension is defined as systolic and diastolic blood pressure equal to or greater than 140 / 90mmHg.

  • birth weight [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • cesarean delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • gestational age [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • premature delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    gestational age <37 weeks at delivery

  • maternal gestational weight gain [ Time Frame: From baseline measurement to delivery: up to 9 months ] [ Designated as safety issue: No ]
    Increatment of body weight from that measured at first prenatal visit (at baseline) to last body weight measurement before delivery with precision of 0.5kg


Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low GI diet counseling
diet coundeling based on Dietary Guidelines for Chinese Residents for pregnant women (total energy intake, protein and vitamin etc.) and low glycemic index diet
Behavioral: Low glycemic diet counseling
Expermental arm recieved diet coundeling based on Dietary Guidelines for Chinese Residents for pregnant women (total energy intake, protein and vitamin etc.) and low glycemic index diet.
Active Comparator: standard diet counseling
diet counseling based on Dietary guidelines for Chinese Residents
Behavioral: Standard diet counseling
provide diet counseling based on Dietary Guidelines for Chinese Residents for pregnant women.

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 consulation 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 consulation 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Pregnant women with first prenatal examination BMI equal to or greater than 24 kg/m2
  • Unipara
  • 18 years to 45years
  • The week of first prenatal examination equal to or less than12 weeks
  • Take routine prenatal examination
  • Willing and able to give informed consent

Exclusion Criteria:

  • Artificial impregnation
  • History of hypertension, diabetes, coronary heart disease or mental disorder
  • Special diet habit(e.g. vegetarianism/ veganism)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628835

Contacts
Contact: Weili Yan, PhD +86 21 64931215 yanwl@fudan.edu.cn
Contact: Peng Shi, MS +86 21 64931215 pshi.fudan@gmail.com

Locations
China, Jiangsu
Kunshan Maternal and Child Health Care Hospital Recruiting
Kunshan, Jiangsu, China, 215301
Contact: Wenhong Yang, MD    +86 512 51308854    d_yang007@sohu.com   
China
International Peace Maternity and Child Care Centers of Shanghai Jiaotong University Recruiting
Shanghai, China, 200030
Contact: Liping Wang, MS    +86 21 64749013    wanglp114@163.com   
Sponsors and Collaborators
Fudan University
Kunshan City Maternal and Child Health
Shanghai Jiao Tong University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Weili Yan, Professor, Director, Fudan University
ClinicalTrials.gov Identifier: NCT01628835     History of Changes
Other Study ID Numbers: LGII-P, 985-3-5
Study First Received: May 10, 2012
Last Updated: July 8, 2013
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014