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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simona Bo, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01506310
First received: December 26, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Birth-weight
Behavioral: Behavioral therapy
Other: Exercise
Other: Behavioral therapy and exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.


Secondary Outcome Measures:
  • Serum fasting insulin values [ Time Frame: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation) ] [ Designated as safety issue: No ]
    To investigate changes from baseline in serum fasting insulin values in each arm.

  • The need for insulin therapy [ Time Frame: At recruitment and at the end of follow-up (38 weeks) ] [ Designated as safety issue: No ]
    The need for insulin therapy in each arm

  • 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 ] [ Designated as safety issue: No ]
    The number of Cesarean sections in each arm

  • The mean birth-weight of newborns [ Time Frame: From recruitment until the date of delivery, assessed up to 42 weeks ] [ Designated as safety issue: No ]
    The mean birth-weight of newborns in each arm


Enrollment: 200
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506310

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

Additional Information:
No publications provided

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
Study First Received: December 26, 2011
Last Updated: January 22, 2013
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014