An Exercise Intervention to Prevent Gestational Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT00728377
First received: August 2, 2008
Last updated: January 9, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Gestational Diabetes
Behavioral: Physical activity
Behavioral: Heath & Wellness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Exercise Intervention to Prevent Recurrent GDM

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • Gestational diabetes diagnosis assessed through glucose tolerance test. [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal weight gain [ Time Frame: 40 weeks gestational age ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • Resistin [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • TNF-alpha [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: 28 weeks gestational age ] [ Designated as safety issue: No ]
  • Birth weight [ Time Frame: 40 weeks gestational age ] [ Designated as safety issue: No ]
  • Apgar score [ Time Frame: 40 weeks gestational age ] [ Designated as safety issue: No ]
  • Adoption and maintenance of exercise during pregnancy [ Time Frame: 40 weeks gestational age ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: July 2007
Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Heath & Wellness 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.
Experimental: Exercise 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728377

Locations
United States, Massachusetts
Batstate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
University of Massachusetts, Amherst
Investigators
Principal Investigator: Lisa Chasan-Taber University of Massachusetts, Amherst
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Chasan-Taber, Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT00728377     History of Changes
Obsolete Identifiers: NCT01141582
Other Study ID Numbers: DK74876, R01DK074876, 1R01 DK074876-01A1
Study First Received: August 2, 2008
Last Updated: January 9, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Massachusetts, Amherst:
gestational diabetes
physical activity
behavior change
glucose tolerance
pregnancy

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on September 02, 2015