Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
|ClinicalTrials.gov Identifier: NCT01506310|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Birth-weight||Behavioral: Behavioral therapy Other: Exercise Other: Behavioral therapy and exercise||Phase 3|
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|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|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.
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
- 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.
- 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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506310
|University of Turin|
|Turin, Italy, 10126|