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

NCT01506310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-23

No results posted yet for this study

Summary

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

  • Birth-weight

Interventions

BEHAVIORAL

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.

OTHER

Exercise

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

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

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506310 on ClinicalTrials.gov