An Exercise Intervention to Prevent Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. It is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent studies have suggested that women with higher levels of physical activity have reduced risk of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing GDM among women with a history of GDM.

Detailed Description
-----------------
The primary goals of the application are to investigate the effects of a motivationally-tailored, individually targeted 12-wk physical activity intervention on 1) risk of GDM in women at high risk of the condition, 2) serum biomarkers associated with insulin resistance, 3) and the adoption and maintenance of exercise during pregnancy. Secondary goals are to investigate the impact of the intervention on gestational weight gain and selected birth outcomes. The overall goal of the intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists (ACOG) Guidelines for physical activity during pregnancy (30 minutes or more of moderate- intensity activity on most days of the week) through increasing walking and developing a more active lifestyle. The intervention draws from the theory of Stages of Motivational Readiness for Change and Social Cognitive Theory constructs for physical activity behavior and will take into account the specific social, cultural, economic, and physical environmental challenges faced by women of diverse socioeconomic and ethnic backgrounds. The application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent GDM among high risk women. The intervention protocol can readily be translated into clinical practice in underserved and minority populations.

Official Title
-----------------
An Exercise Intervention to Prevent Recurrent GDM

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

Intervention / Treatment
-----------------
* Behavioral: Physical activity
* Behavioral: Heath & Wellness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of gestational diabetes or overweight (>25 kg/m2) with family history of type 2 diabetes sedentary Exclusion Criteria: history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease current medications which adversely influence glucose tolerance not planning to continue the pregnancy to term >16 weeks gestation contraindications to participating in moderate physical activity inability to read English at a 6th grade level self-reported participation in >30 min of moderate or vigorous-intensity exercise on >3 days/wk prior participation in the study non-singleton pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

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 |
| --- | --- |
| Active Comparator: Heath & Wellness<br> | Behavioral: Heath & Wellness<br>* The comparison intervention consists of a series of informational booklets published by the American College of Obstetricians and Gynecologists on general issues related to health and wellness during pregnancy. These include alcohol and drug use during pregnancy, easing back pain, as well as the Pregnancy Fitness brochure on the safety of exercise during pregnancy. These booklets are selected to represent high-quality, standard, low-cost, self-help material currently available to the public.<br>|
| Experimental: Exercise<br> | Behavioral: Physical activity<br>* Individually Tailored (IT) Exercise Intervention This intervention is designed to increase the amount of physical activity incorporated into the daily lifestyle of pregnant women, primarily through increased walking, with the ultimate goal of achieving the American College of Obstetricians and Gynecologists (ACOG) exercise goals for pregnant women. These goals are the same as the Surgeon General's Guidelines for physical activity for nonpregnant individuals (30 minutes or more or moderate activity on most days of the week).The intervention includes: 1) individually tailored print-based materials (i.e., individually-tailored reports and stage-matched manuals), 2) self-monitoring materials, and 3) goal setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes diagnosis assessed through glucose tolerance test. |  | 28 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight gain |  | 40 weeks gestational age | 
| Glucose |  | 28 weeks gestational age | 
| Insulin |  | 28 weeks gestational age | 
| Adiponectin |  | 28 weeks gestational age | 
| Resistin |  | 28 weeks gestational age | 
| TNF-alpha |  | 28 weeks gestational age | 
| CRP |  | 28 weeks gestational age | 
| Birth weight |  | 40 weeks gestational age | 
| Apgar score |  | 40 weeks gestational age | 
| Adoption and maintenance of exercise during pregnancy |  | 40 weeks gestational age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gestational diabetes, physical activity, behavior change, glucose tolerance, pregnancy