Clinical trial NCT01628835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Pregnant Women
Keywords: overweight
pregnancy
diet counselling
glycemic
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Kunshan City Maternal and Child Health
name: Shanghai Jiao Tong University School of Medicine
First posted: 2012-06-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Maternal insulin resistance
timeFrame: During pregnancy
measure: Cord blood C-peptide
timeFrame: at delivery
measure: Maternal weight gain
timeFrame: measured before delivery
measure: Incidence of gestational diabetes
timeFrame: during pregnancy
measure: Incidence of macrosomia
timeFrame: at delivery
Secondary outcomes:
measure: Incidence of gestational hypertension
timeFrame: during pregnancy
measure: Mean infant birth weight
timeFrame: at delivery
measure: cesarean
timeFrame: at delivery
measure: head circumference
timeFrame: at delivery
measure: Mean gestational age
timeFrame: at delivery
measure: Incidence of premature delivery
timeFrame: at delivery
Other outcomes:
Locations:
city: Kunshan city
country: China
facility: Kunshan Maternal and Child Health Care Hospital
state: Jiangsu
city: Shanghai
country: China
facility: International Peace Maternity and Child Care Centers of Communications University
Study officials:
References:
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.