Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
|Birth-weight||Behavioral: Behavioral therapy Other: Exercise Other: Behavioral therapy and exercise||Phase 3|
|Study Design:||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).|
- 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
|Study Start Date:||July 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506310
|University of Turin|
|Turin, Italy, 10126|