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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).

Conditions
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Birth-weight

Intervention / Treatment
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* Behavioral: Behavioral therapy
* Other: Exercise
* Other: Behavioral therapy and exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Diet alone<br> | |
| Experimental: Behavioral therapy<br> | Behavioral: Behavioral therapy<br>* 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.<br>|
| Experimental: Exercise<br> | Other: Exercise<br>* The exercise groups will be advised to walk at least 20-minute a day.<br>|
| Experimental: Behavioral therapy and exercise<br> | Other: Behavioral therapy and exercise<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum fasting glucose values. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum fasting insulin values | To investigate changes from baseline in serum fasting insulin values in each arm. | 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 | At recruitment and at the end of follow-up (38 weeks) | 
| The number of Cesarean sections | The number of Cesarean sections in each arm | 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 | From recruitment until the date of delivery, assessed up to 42 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes mellitus, fasting glucose, insulin resistance, birth-weight, Glucose values, Insulin concentrations, Cesarean sections