Prevention of Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Gestational diabetes mellitus (GDM)is a major health problem growing prevalence of obesity the older age of pregnant women A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM. feasibility of an early intervention glucose tolerance at weeks 26-28

Detailed Description
-----------------
A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12 voluntary women in early pregnancy (n=96) 54 high risk mothers were randomized lifestyle intervention group (n=27) close follow-up (n=27) An OGTT was performed again at weeks 26-28 the lifestyle intervention group (n=27) the close follow-up group (n=27) other high-risk women of the early care group (n=42)who were not randomized An OGTT was also performed at weeks 26-28 in two neighboring municipalities a standard care high-risk group(n=171)who did not undergo early intervention Primary outcomes number of at risk participants developing GDM during pregnancy in the two arms Secondary outcomes the effect of intervention on fetal growth

Official Title
-----------------
Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Behavioral: Lifestyle: diet and exercise
* Behavioral: Close follow-up: reporting diaries of food and exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk for gestational diabetes fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l Exclusion Criteria: normal glucose tolerance at weeks 8-12 gestational diabetes at weeks 8-12
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lifestyle, follow-up, early care, standard care high/low risk<br>Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy. | Behavioral: Lifestyle: diet and exercise<br>* Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.<br>|
| Other: Close follow-up<br>Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly. | Behavioral: Close follow-up: reporting diaries of food and exercise<br>* Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of at risk participants developing GDM during pregnancy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of intervention on fetal growth |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes