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NCT Number: NCT01628835

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kunshan Maternal and Child Health Care Hospital, Kunshan, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low dietary glycemic index diet

Behavioral

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

National recommendation diet

Behavioral

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

Other names: recommended diet for pregnant women

Primary outcomes

  1. Maternal insulin resistance

    Time frame: During pregnancy

  2. Cord blood C-peptide

    Time frame: at delivery

  3. Maternal weight gain

    Time frame: measured before delivery

    measured before delivery (minus pre-conceptual body weight)

  4. Incidence of gestational diabetes

    Time frame: during pregnancy

    from 1st antenatal visit to delivery

  5. Incidence of macrosomia

    Time frame: at delivery

    birth weight >= 4000g

Secondary outcomes

  1. Incidence of gestational hypertension

    Time frame: during pregnancy

    proportion of patients with SBP/SBP>=140/90 for 3 visits

  2. Mean infant birth weight

    Time frame: at delivery

  3. cesarean

    Time frame: at delivery

  4. head circumference

    Time frame: at delivery

  5. Mean gestational age

    Time frame: at delivery

  6. Incidence of premature delivery

    Time frame: at delivery

    gestational age <37 week at delivery

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Kunshan City Maternal and Child Health
  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2012
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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