An interventional study of Low dietary glycemic index diet and National recommendation diet in Overweight and Pregnant Women, sponsored by Children's Hospital of Fudan University. Completed at 2 sites in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-08-24.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Prevention
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 400 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
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Inclusion
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
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Behavioral: National recommendation 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
Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
Also known as: recommended diet for pregnant women
Maternal insulin resistance
Time frame: During pregnancy
Cord blood C-peptide
Time frame: at delivery
Maternal weight gain
measured before delivery (minus pre-conceptual body weight)
Time frame: measured before delivery
Incidence of gestational diabetes
from 1st antenatal visit to delivery
Time frame: during pregnancy
Incidence of macrosomia
birth weight \>= 4000g
Time frame: at delivery
Incidence of gestational hypertension
proportion of patients with SBP/SBP\>=140/90 for 3 visits
Time frame: during pregnancy
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
gestational age \<37 week at delivery
Time frame: at delivery
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University