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

Not Applicable

• Conditions: Diabetes, Gestational
• Interventions: Behavioral: Individualized medical nutrition therapy

• Registration Number: NCT02893072
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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 Description

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Women with gestational diabetes

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualized medical nutrition therapy	Individualized medical nutrition therapy	A comparison of normal lifestyle and medical nutrition therapy after intervention in the same individual

Primary Outcome Measures

Name	Time	Method
intravenous glucose	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.

Trial Locations

Locations (1)

the Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China