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

NCT ID: NCT02893072

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes, Gestational

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized medical nutrition therapy

A comparison of normal lifestyle and medical nutrition therapy after intervention in the same individual

Group Type EXPERIMENTAL

Individualized medical nutrition therapy

Intervention Type BEHAVIORAL

The intervention group involves dietary and exercise advice and monitoring.

Interventions

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Individualized medical nutrition therapy

The intervention group involves dietary and exercise advice and monitoring.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women with gestational diabetes

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Liu, M.D.

Role: STUDY_DIRECTOR

specify unaffiliated

Locations

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the Third Xiangya Hospital of Central South University

Changsha, Hu'nan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Liu, M.D.

Role: CONTACT

86-731-88618717

Meng Wang, M.M.

Role: CONTACT

86-731-88618717

Facility Contacts

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Min Liu, M.D.

Role: primary

86-731-88618717

Meng Wang, M.M.

Role: backup

86-731-88618717

Other Identifiers

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YYK-2016-002

Identifier Type: -

Identifier Source: org_study_id

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