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

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ClinicalTrials.gov Identifier: NCT01506310
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Simona Bo, University of Turin, Italy

Brief 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.

Condition or disease Intervention/treatment Phase
Birth-weight Behavioral: Behavioral therapy Other: Exercise Other: Behavioral therapy and exercise Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Study Start Date : July 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Diet alone
Experimental: Behavioral therapy 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.
Experimental: Exercise Other: Exercise
The exercise groups will be advised to walk at least 20-minute a day.
Experimental: Behavioral therapy and exercise 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




Primary Outcome Measures :
  1. Serum fasting glucose values. [ Time Frame: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation) ]
    To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.


Secondary Outcome Measures :
  1. Serum fasting insulin values [ Time Frame: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation) ]
    To investigate changes from baseline in serum fasting insulin values in each arm.

  2. The need for insulin therapy [ Time Frame: At recruitment and at the end of follow-up (38 weeks) ]
    The need for insulin therapy in each arm

  3. The number of Cesarean sections [ Time Frame: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks ]
    The number of Cesarean sections in each arm

  4. The mean birth-weight of newborns [ Time Frame: From recruitment until the date of delivery, assessed up to 42 weeks ]
    The mean birth-weight of newborns in each arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506310


Locations
Italy
University of Turin
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simona Bo, Principal Investigator, MD, Professor Assistant, Department of Internal Medicine, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01506310     History of Changes
Other Study ID Numbers: sbo2010
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Simona Bo, University of Turin, Italy:
gestational diabetes mellitus
fasting glucose
insulin resistance
birth-weight
Glucose values
Insulin concentrations
Cesarean sections

Additional relevant MeSH terms:
Diabetes Mellitus
Birth Weight
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Pregnancy Complications