Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

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Detailed Description

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Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.

The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Conditions

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Birth-weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavioral therapy

Group Type EXPERIMENTAL

Behavioral therapy

Intervention Type BEHAVIORAL

General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.

Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise groups will be advised to walk at least 20-minute a day.

Behavioral therapy and exercise

Group Type EXPERIMENTAL

Behavioral therapy and exercise

Intervention Type OTHER

General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.

Written recommendations for physical activity A brief written guide on behavior change

Interventions

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Behavioral therapy

General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.

Intervention Type BEHAVIORAL

Exercise

The exercise groups will be advised to walk at least 20-minute a day.

Intervention Type OTHER

Behavioral therapy and exercise

General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.

Written recommendations for physical activity A brief written guide on behavior change

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age between 24 and 26 weeks
* Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
* Singleton pregnancy

Exclusion Criteria

* Body mass index \> 40 or \< 12kg/m2
* Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
* Patients on any drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes