Clinical Trial: Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Individualized Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes

Brief Summary: Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. The overall purpose of this study is to determine the efficacy of individualized medical nutrition therapy (MNT) intervention to reduce and control the development of GDM.

Detailed Summary: The number of women with gestational diabetes mellitus 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 MNT intervention in pregnant women in Hu'nan province. The aim of this study is to evaluate the efficacy of individualized MNT intervention to reduce and control the development of GDM. This is a prospective study, 500 patients who meet inclusion and exclusion criteria will be included. The changes of glucose and weight will be evaluated every two weeks.
Sponsor: The Third Xiangya Hospital of Central South University

Current Primary Outcome:

• intravenous glucose [ Time Frame: every two weeks, from date of randomization until the date of parturition, assessed up to 10 months ]
  Investigators will measure the participants' intravenous glucose every two weeks.From date of randomization until the date of parturition,assessed up to 10 months.
• weight in kilograms assessed by vertical personnel weighing scale [ Time Frame: every two weeks, from date of randomization until the date of parturition, assessed up to 10 months ]
  The participants will be weighed every two weeks by vertical personnel weighing scale, up to parturition of the participants.
• fetal growth level [ Time Frame: every two weeks or one month, from date of randomization until the date of parturition, assessed up to 10 months ]
  The growth level of fetal will be monitored by obstetrician.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Third Xiangya Hospital of Central South University

Dates:
Date Received: August 23, 2016
Date Started: November 2015
Date Completion: December 2017
Last Updated: September 1, 2016
Last Verified: August 2016