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

Overweight Clinical Trial

Official title:

Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628835
• Other study ID #: version1.0
• Secondary ID: NSFC 81273168
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: August 23, 2016
• Start date: June 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Pregnant Women

Intervention

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

Locations

Country	Name	City	State
China	Kunshan Maternal and Child Health Care Hospital	Kunshan city	Jiangsu
China	International Peace Maternity and Child Care Centers of Communications University	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Kunshan City Maternal and Child Health, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal insulin resistance		During pregnancy	No
Primary	Cord blood C-peptide		at delivery	No
Primary	Maternal weight gain	measured before delivery (minus pre-conceptual body weight)	measured before delivery	No
Primary	Incidence of gestational diabetes	from 1st antenatal visit to delivery	during pregnancy	No
Primary	Incidence of macrosomia	birth weight >= 4000g	at delivery	No
Secondary	Incidence of gestational hypertension	proportion of patients with SBP/SBP>=140/90 for 3 visits	during pregnancy	No
Secondary	Mean infant birth weight		at delivery	No
Secondary	cesarean		at delivery	No
Secondary	head circumference		at delivery	No
Secondary	Mean gestational age		at delivery	No
Secondary	Incidence of premature delivery	gestational age <37 week at delivery	at delivery	No

External Links

•   Children's Hospital of Fudan University