Birth-weight
Conditions
Keywords
gestational diabetes mellitus, fasting glucose, insulin resistance, birth-weight, Glucose values, Insulin concentrations, Cesarean sections
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral 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.
OTHERExercise
The exercise groups will be advised to walk at least 20-minute a day.
OTHERBehavioral 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
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum fasting glucose values. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum fasting insulin values | 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 | At recruitment and at the end of follow-up (38 weeks) | The need for insulin therapy in each arm |
| The number of Cesarean sections | 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 | From recruitment until the date of delivery, assessed up to 42 weeks | The mean birth-weight of newborns in each arm |
Countries
Italy
Outcome results
None listed