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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 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, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT01628835
First received: May 10, 2012
Last updated: December 15, 2014
Last verified: December 2014
  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
Pregnant Women
Behavioral: Low dietary glycemic index diet
Behavioral: National recommendation diet

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.

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Maternal insulin resistance [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Cord blood C-peptide [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Maternal weight gain [ Time Frame: measured before delivery ] [ Designated as safety issue: No ]
    measured before delivery (minus pre-conceptual body weight)

  • Incidence of gestational diabetes [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
    from 1st antenatal visit to delivery

  • Incidence of macrosomia [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    birth weight >= 4000g


Secondary Outcome Measures:
  • Incidence of gestational hypertension [ Time Frame: during pregancy ] [ Designated as safety issue: No ]
    proportion of patients with SBP/SBP>=140/90 for 3 visits

  • Mean infant birth weight [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • cesarean [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • head circumference [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Mean gestational age [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Incidence of premature delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    geatational age <37 week at delivery


Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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
Active Comparator: National recommendation diet
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Behavioral: National recommendation diet
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Other Name: recommended diet 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

  • Singleton pregnancy;
  • Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
  • aged 18 years to 45 years;
  • The week of first prenatal examination equal to or less than 12 weeks;
  • Take routine prenatal examination;
  • Willing and able to give informed consent. Exclusion
  • Artificial impregnation;
  • History of hypertension, diabetes, coronary heart disease or mental disorder;
  • With 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 city, Jiangsu, China
Contact: Wenhong Yang, MD    +86 0512 57381689    d_yang007@sohu.com   
China
International Peace Maternity and Child Care Centers of Communications University Completed
Shanghai, China, 201102
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, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT01628835     History of Changes
Other Study ID Numbers: version1.0, NSFC 81273168
Study First Received: May 10, 2012
Last Updated: December 15, 2014
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
overweight, pregnancy, diet conselling, glycemic

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2015