Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study
Individualized Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 19, 2019
April 1, 2019
5.1 years
August 23, 2016
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
every two weeks, from date of randomization until the date of parturition, assessed up to 10 months
Study Arms (1)
Individualized medical nutrition therapy
EXPERIMENTALA comparison of normal lifestyle and medical nutrition therapy after intervention in the same individual
Interventions
The intervention group involves dietary and exercise advice and monitoring.
Eligibility Criteria
You may qualify if:
- Women with gestational diabetes
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Third Xiangya Hospital of Central South University
Changsha, Hu'nan, 410013, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Min Liu, M.D.
specify unaffiliated
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2016
First Posted
September 8, 2016
Study Start
November 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 19, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be available in June 2018.
- Access Criteria
- Every body can get the information we shared.
During and after our experiment, investigators will share the development in the website.