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

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.

gestational diabetes mellitus, fasting glucose, insulin resistance, birth-weight, Glucose values, Insulin concentrations, Cesarean sections

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.

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

To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.

Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)

From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks

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

Bo S, Gambino R, Menato G, Canil S, Ponzo V, Pinach S, Durazzo M, Ghigo E, Cassader M, Musso G. Isoleucine-to-methionine substitution at residue 148 variant of PNPLA3 gene and metabolic outcomes in gestational diabetes. Am J Clin Nutr. 2015 Feb;101(2):310-8. doi: 10.3945/ajcn.114.095125. Epub 2014 Dec 17.