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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628835
First Posted: June 27, 2012
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.

Further study details as provided by Weili Yan, Children's Hospital of Fudan University:

Primary Outcome Measures:
  • Maternal insulin resistance [ Time Frame: During pregnancy ]
  • Cord blood C-peptide [ Time Frame: at delivery ]
  • Maternal weight gain [ Time Frame: measured before delivery ]
    measured before delivery (minus pre-conceptual body weight)

  • Incidence of gestational diabetes [ Time Frame: during pregnancy ]
    from 1st antenatal visit to delivery

  • Incidence of macrosomia [ Time Frame: at delivery ]
    birth weight >= 4000g


Secondary Outcome Measures:
  • Incidence of gestational hypertension [ Time Frame: during pregnancy ]
    proportion of patients with SBP/SBP>=140/90 for 3 visits

  • Mean infant birth weight [ Time Frame: at delivery ]
  • cesarean [ Time Frame: at delivery ]
  • head circumference [ Time Frame: at delivery ]
  • Mean gestational age [ Time Frame: at delivery ]
  • Incidence of premature delivery [ Time Frame: at delivery ]
    gestational age <37 week at delivery


Enrollment: 400
Study Start Date: June 2012
Study Completion Date: March 2016
Primary Completion Date: February 2016 (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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628835


Locations
China, Jiangsu
Kunshan Maternal and Child Health Care Hospital
Kunshan city, Jiangsu, China
China
International Peace Maternity and Child Care Centers of Communications University
Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Kunshan City Maternal and Child Health
Shanghai Jiao Tong University School of Medicine
  More Information

Additional Information:
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 ( Other Grant/Funding Number: National Science Fundation of China )
First Submitted: May 10, 2012
First Posted: June 27, 2012
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by Weili Yan, Children's Hospital of Fudan University:
overweight
pregnancy
diet counselling
glycemic

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms