search
Back to results

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

Primary Purpose

Overweight, Pregnant Women

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low dietary glycemic index diet
National recommendation diet
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, pregnancy, diet counselling, glycemic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Kunshan Maternal and Child Health Care Hospital
  • International Peace Maternity and Child Care Centers of Communications University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low dietary glycemic index diet

National recommendation diet

Arm Description

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.

Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2012
Last Updated
August 23, 2016
Sponsor
Children's Hospital of Fudan University
Collaborators
Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01628835
Brief Title
Low Glycemic Index (GI) Diet Management for Pregnant Woman With Overweight
Official Title
Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Pregnant Women
Keywords
overweight, pregnancy, diet counselling, glycemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dietary glycemic index diet
Arm Type
Experimental
Arm Description
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.
Arm Title
National recommendation diet
Arm Type
Active Comparator
Arm Description
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Intervention Type
Behavioral
Intervention Name(s)
Low dietary glycemic index diet
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
National recommendation diet
Other Intervention Name(s)
recommended diet for pregnant women
Intervention Description
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Primary Outcome Measure Information:
Title
Maternal insulin resistance
Time Frame
During pregnancy
Title
Cord blood C-peptide
Time Frame
at delivery
Title
Maternal weight gain
Description
measured before delivery (minus pre-conceptual body weight)
Time Frame
measured before delivery
Title
Incidence of gestational diabetes
Description
from 1st antenatal visit to delivery
Time Frame
during pregnancy
Title
Incidence of macrosomia
Description
birth weight >= 4000g
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
Incidence of gestational hypertension
Description
proportion of patients with SBP/SBP>=140/90 for 3 visits
Time Frame
during pregnancy
Title
Mean infant birth weight
Time Frame
at delivery
Title
cesarean
Time Frame
at delivery
Title
head circumference
Time Frame
at delivery
Title
Mean gestational age
Time Frame
at delivery
Title
Incidence of premature delivery
Description
gestational age <37 week at delivery
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Kunshan Maternal and Child Health Care Hospital
City
Kunshan city
State/Province
Jiangsu
Country
China
Facility Name
International Peace Maternity and Child Care Centers of Communications University
City
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30998227
Citation
Zhang Y, Wang L, Yang W, Niu D, Li C, Wang L, Gu P, Xia Y, Shen Y, Yan J, Zhao Q, Mu K, Yan W. Effectiveness of Low Glycemic Index Diet Consultations Through a Diet Glycemic Assessment App Tool on Maternal and Neonatal Insulin Resistance: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12081. doi: 10.2196/12081.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs