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NCT Number: NCT00728377

An Exercise Intervention to Prevent Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Batstate Medical Center

Springfield, Massachusetts, 01199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Gestational diabetes diagnosis assessed through glucose tolerance test.

    Time frame: 28 weeks gestational age

Secondary outcomes

  1. Maternal weight gain

    Time frame: 40 weeks gestational age

  2. Glucose

    Time frame: 28 weeks gestational age

  3. Insulin

    Time frame: 28 weeks gestational age

  4. Adiponectin

    Time frame: 28 weeks gestational age

  5. Resistin

    Time frame: 28 weeks gestational age

  6. TNF-alpha

    Time frame: 28 weeks gestational age

  7. CRP

    Time frame: 28 weeks gestational age

  8. Birth weight

    Time frame: 40 weeks gestational age

  9. Apgar score

    Time frame: 40 weeks gestational age

  10. Adoption and maintenance of exercise during pregnancy

    Time frame: 40 weeks gestational age

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

An Exercise Intervention to Prevent Recurrent GDM

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Aug 5, 2008
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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