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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Pregnant Women
• Intervention / Treatment: Behavioral: Low dietary glycemic index diet; Behavioral: National recommendation diet

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201102
    • International Peace Maternity and Child Care Centers of Communications University
  • Jiangsu
    • Kunshan city, Jiangsu, China
      • Kunshan Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: recommended diet for pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal insulin resistance		During pregnancy
Cord blood C-peptide		at delivery
Maternal weight gain	measured before delivery (minus pre-conceptual body weight)	measured before delivery
Incidence of gestational diabetes	from 1st antenatal visit to delivery	during pregnancy
Incidence of macrosomia	birth weight >= 4000g	at delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Shanghai Jiao Tong University School of Medicine; Kunshan City Maternal and Child Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: overweight; pregnancy; glycemic; diet counselling
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: version1.0; NSFC 81273168 (Other Grant/Funding Number: National Science Fundation of China)