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

Fudan University

Status: Completed

Conditions: Overweight; Pregnant Women

Treatments: Behavioral: National recommendation diet; Behavioral: Low dietary glycemic index diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01628835

NSFC 81273168 (Other Grant/Funding Number)

version1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Low dietary glycemic index diet

Experimental group

Description:

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.

Treatment:

Behavioral: Low dietary glycemic index diet

National recommendation diet

Active Comparator group

Description:

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

Treatment:

Behavioral: National recommendation diet