Overweight Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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