Birth-weight Clinical Trial
Official title:
Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment