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An Exercise Intervention to Prevent Gestational Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728377
First Posted: August 5, 2008
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst
August 2, 2008
August 5, 2008
October 26, 2016
July 2007
November 2011   (Final data collection date for primary outcome measure)
Gestational diabetes diagnosis assessed through glucose tolerance test. [ Time Frame: 28 weeks gestational age ]
Same as current
Complete list of historical versions of study NCT00728377 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Exercise Intervention to Prevent Gestational Diabetes
An Exercise Intervention to Prevent Recurrent GDM
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Gestational Diabetes
  • 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.
  • Behavioral: 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.
  • Active Comparator: Heath & Wellness
    Intervention: Behavioral: Heath & Wellness
  • Experimental: Exercise
    Intervention: Behavioral: Physical activity

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
November 2012
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00728377
DK74876
R01DK074876 ( U.S. NIH Grant/Contract )
1R01DK074876-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Lisa Chasan-Taber, University of Massachusetts, Amherst
University of Massachusetts, Amherst
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Lisa Chasan-Taber University of Massachusetts, Amherst
University of Massachusetts, Amherst
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP