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

Central South University

Status: Unknown

Conditions: Diabetes, Gestational

Treatments: Behavioral: Individualized medical nutrition therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02893072

YYK-2016-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with gestational diabetes

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Individualized medical nutrition therapy

Experimental group

Description:

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

Treatment:

Behavioral: Individualized medical nutrition therapy