An interventional study of Physical activity and Heath & Wellness in Gestational Diabetes, sponsored by University of Massachusetts, Amherst. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Prevention
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 488 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Massachusetts, Amherst is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Behavioral: Heath & Wellness
Behavioral: Physical activity
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.
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.
Gestational diabetes diagnosis assessed through glucose tolerance test.
Time frame: 28 weeks gestational age
Maternal weight gain
Time frame: 40 weeks gestational age
Glucose
Time frame: 28 weeks gestational age
Insulin
Time frame: 28 weeks gestational age
Adiponectin
Time frame: 28 weeks gestational age
Resistin
Time frame: 28 weeks gestational age
TNF-alpha
Time frame: 28 weeks gestational age
CRP
Time frame: 28 weeks gestational age
Birth weight
Time frame: 40 weeks gestational age
Apgar score
Time frame: 40 weeks gestational age
Adoption and maintenance of exercise during pregnancy
Time frame: 40 weeks gestational age
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Amherst