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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01628835
Enrollment
400
Registered
2012-06-27
Start date
2012-06-30
Completion date
2016-03-31
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Pregnant Women

Keywords

overweight, pregnancy, diet counselling, glycemic

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.

Interventions

BEHAVIORALLow 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

BEHAVIORALNational recommendation diet

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

Sponsors

Kunshan City Maternal and Child Health
CollaboratorOTHER
Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion 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).

Design outcomes

Primary

MeasureTime frameDescription
Maternal insulin resistanceDuring pregnancy
Cord blood C-peptideat delivery
Maternal weight gainmeasured before deliverymeasured before delivery (minus pre-conceptual body weight)
Incidence of gestational diabetesduring pregnancyfrom 1st antenatal visit to delivery
Incidence of macrosomiaat deliverybirth weight \>= 4000g

Secondary

MeasureTime frameDescription
Incidence of gestational hypertensionduring pregnancyproportion of patients with SBP/SBP\>=140/90 for 3 visits
Incidence of premature deliveryat deliverygestational age \<37 week at delivery
Mean infant birth weightat delivery
cesareanat delivery
head circumferenceat delivery
Mean gestational ageat delivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026