An Exercise Intervention to Prevent Gestational Diabetes
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
488 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal