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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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
University of Turin
Turin, Italy, Italy
Serum fasting glucose values.
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
Time frame: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
Serum fasting insulin values
To investigate changes from baseline in serum fasting insulin values in each arm.
Time frame: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
The need for insulin therapy
The need for insulin therapy in each arm
Time frame: At recruitment and at the end of follow-up (38 weeks)
The number of Cesarean sections
The number of Cesarean sections in each arm
Time frame: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
The mean birth-weight of newborns
The mean birth-weight of newborns in each arm
Time frame: From recruitment until the date of delivery, assessed up to 42 weeks
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