Lifestyle Intervention and Prevention of Gestational Diabetes Mellitus

February 2, 2017 updated by: Ruth Chan, Chinese University of Hong Kong

A Randomized Controlled Trial Examining the Effectiveness of a Lifestyle Intervention in Reducing Gestational Diabetes Mellitus in High Risk Chinese Pregnant Women in Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
NO_INTERVENTION: Usual care
Women will have their first AN booking visit generally on or before 12 week gestation. For women who are primigravida, their AN visit appointments will be set at every 6 weeks before 24 weeks, every 4 weeks between 24-28 weeks, and every 2 weeks after 28 weeks. For women who are multigravida, the corresponding schedules will be set at every 6 weeks before 24 weeks, every 4 weeks between 24-36 weeks, and every 2 weeks after 36 weeks. Body weight of the pregnant woman will be monitored by nurses and basic nutrition advice will be briefly given by nurses in case she is slightly overweight. They will be provided with an educational pamphlet on diet and exercise during pregnancy. They will also be offered optional antenatal classes which subjected to quotas availability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects developed GDM
Time Frame: 24-28 weeks gestation
24-28 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of neonates born with large for gestational age (LGA)
Time Frame: within 48 hours after delivery
within 48 hours after delivery
Proportion of neonates born with macrosomia
Time Frame: within 48 hours after delivery
within 48 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 21, 2015

Primary Completion (ACTUAL)

June 28, 2016

Study Completion (ACTUAL)

December 30, 2016

Study Registration Dates

First Submitted

February 15, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (ESTIMATE)

February 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.373-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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