Back to resultsMedical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study
Primary Purpose
Diabetes, Gestational
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized medical nutrition therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Gestational focused on measuring Diabetes, Gestational, Nutrition Therapy
Eligibility Criteria
Inclusion Criteria:
- Women with gestational diabetes
Exclusion Criteria:
- None
Sites / Locations
- the Third Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individualized medical nutrition therapy
Arm Description
A comparison of normal lifestyle and medical nutrition therapy after intervention in the same individual
Outcomes
Primary Outcome Measures
intravenous glucose
Investigators will measure the participants' intravenous glucose every two weeks.From date of randomization until the date of parturition,assessed up to 10 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT02893072
First Posted
August 23, 2016
Last Updated
April 17, 2019
Sponsor
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT02893072
Brief Title
Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study
Official Title
Individualized Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Diabetes, Gestational, Nutrition Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized medical nutrition therapy
Arm Type
Experimental
Arm Description
A comparison of normal lifestyle and medical nutrition therapy after intervention in the same individual
Intervention Type
Behavioral
Intervention Name(s)
Individualized medical nutrition therapy
Intervention Description
The intervention group involves dietary and exercise advice and monitoring.
Primary Outcome Measure Information:
Title
intravenous glucose
Description
Investigators will measure the participants' intravenous glucose every two weeks.From date of randomization until the date of parturition,assessed up to 10 months.
Time Frame
every two weeks, from date of randomization until the date of parturition, assessed up to 10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with gestational diabetes
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Liu, M.D.
Phone
86-731-88618717
Email
liumin330@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Wang, M.M.
Phone
86-731-88618717
Email
znxywm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
Organizational Affiliation
specify unaffiliated
Official's Role
Study Director
Facility Information:
Facility Name
the Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
Phone
86-731-88618717
Email
liumin330@hotmail.com
First Name & Middle Initial & Last Name & Degree
Meng Wang, M.M.
Phone
86-731-88618717
Email
znxywm@163.com
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
During and after our experiment, investigators will share the development in the website.
IPD Sharing Time Frame
The data will be available in June 2018.
IPD Sharing Access Criteria
Every body can get the information we shared.
Learn more about this trial
Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study
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