Lifestyle Intervention and Prevention of Gestational Diabetes Mellitus

Not Applicable

Completed

Brief Summary: The number of women with gestational diabetes mellitus (GDM) had been increasing. Maternal GDM has a great impact on both the health of the mothers and the offspring. Antenatal lifestyle interventions, in particular dietary intervention appear to be feasible to improve maternal GDM and weight gain. To the best of our knowledge, there has been no such trial examining the feasibility of a lifestyle intervention in pregnant women in Hong Kong. Therefore, we plan to conduct a randomized controlled trial comparing a lifestyle modification program (LMP) in early pregnancy and the usual antenatal care in high risk Chinese pregnant women in Hong Kong. Intervention group subjects (n=110) will participate in a dietitian-led LMP including dietary and exercise component from the first antenatal (AN) booking to 24 weeks gestation. 110 women in the control group will receive routine hospital antenatal care. The primary endpoint will be the prevalence of GDM measured using a 75 g oral glucose tolerance test at 24-28 weeks gestation. The secondary endpoints will be the proportion of infant born with large for gestational age (\>=95th percentile of the customized birth weight) and macrosomia (\>=4 kg at birth). The intervention group involves dietary and exercise advice and monitoring. No drug or invasive procedure is involved. The control group will receive routine antenatal care and will be provided with an educational pamphlet on diet and exercise during pregnancy.

Recruitment & Eligibility

Inclusion Criteria

Chinese origin
Reside normally in Hong Kong
Singleton pregnancy
Gestational age <= 12 weeks at the time of recruitment
Could speak and understand Chinese
Fulfill at least one of the following criteria for high risk of GDM at the time of recruitment based on the update hospital protocol implemented since 1st May 2014
Maternal age >= 35 years old at expected date of confinement.
Prior history of GDM or birth of child >= 4 kg
Pre-pregnant BMI or BMI at 1st trimester >= 25 kg/m2
Family history of diabetes at 1st degree relatives
Willing to give informed written consent and follow the study procedures

Exclusion Criteria

Concurrent participation in any clinical trial or study
With renal, liver or thyroid dysfunction, cognitive impairment, or any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study
Multiple pregnancies
Pre-existing DM
With physical restriction that prevents from exercising
Substance abuse

Arm && Interventions

Group	Intervention	Description
Lifestyle modification program	Lifestyle modification program	On top of the usual care, subjects in the intervention will receive a lifestyle intervention that will be delivered by experienced registered dietitian and exercise specialist. There will be 5 face-to-face dietitian consultations, 2 telephone dietitian consultations and at least one face-to-face exercise specialist consultation. The exercise consultation will be normally scheduled on the same day of the face-to-face dietitian consultation.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects developed GDM	24-28 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Proportion of neonates born with macrosomia	within 48 hours after delivery
Proportion of neonates born with large for gestational age (LGA)	within 48 hours after delivery

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