An Exercise Intervention to Prevent Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

An Exercise Intervention to Prevent Recurrent GDM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728377
• Other study ID #: DK74876
• Secondary ID: R01DK0748761R01D
• Status: Completed
• Phase: N/A
• First received: August 2, 2008
• Last updated: October 24, 2016
• Start date: July 2007
• Est. completion date: November 2012

Study information

• Verified date: October 2016
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01141582

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: November 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.
• Heath & Wellness
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.

Locations

Country	Name	City	State
United States	Batstate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hawkins M, Chasan-Taber L, Marcus B, Stanek E, Braun B, Ciccolo J, Markenson G. Impact of an exercise intervention on physical activity during pregnancy: the behaviors affecting baby and you study. Am J Public Health. 2014 Oct;104(10):e74-81. doi: 10.2105/AJPH.2014.302072. Epub 2014 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes diagnosis assessed through glucose tolerance test.		28 weeks gestational age	No
Secondary	Maternal weight gain		40 weeks gestational age	No
Secondary	Glucose		28 weeks gestational age	No
Secondary	Insulin		28 weeks gestational age	No
Secondary	Adiponectin		28 weeks gestational age	No
Secondary	Resistin		28 weeks gestational age	No
Secondary	TNF-alpha		28 weeks gestational age	No
Secondary	CRP		28 weeks gestational age	No
Secondary	Birth weight		40 weeks gestational age	No
Secondary	Apgar score		40 weeks gestational age	No
Secondary	Adoption and maintenance of exercise during pregnancy		40 weeks gestational age	No