Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome

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. Identifier: NCT00647595
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : April 22, 2015
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
The purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study.

Condition or disease Intervention/treatment Phase
Obesity Pregnancy Diabetes Mellitus Behavioral: Experimental group Phase 3

Detailed Description:
Obesity and overweight have become important public health problems in the United States, and measures are urgently needed to address these issues. For many women, pregnancy is a time of excessive weight gain and decreases in physical fitness, both of which may be followed by postpartum weight retention. Women who develop hypertension or diabetes mellitus during pregnancy are at higher risk for development of these disorders in the future. Because of the implications of pregnancy-related weight gain and the metabolic changes during pregnancy for future maternal health, interventions to maintain or improve fitness during pregnancy may have important downstream health effects. In addition, maternal metabolic parameters and the intra-uterine environment have important implications for neonatal outcomes and subsequent child health. This study will provide data about the effects of an intervention to increase vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: A
Women in this group will exercise 3x per week at a moderate/vigorous level for 45 min per session through their 36 week of pregnancy.
Behavioral: Experimental group
Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.
No Intervention: B
Women in this group will continue their usual activities throughout their pregnancy.

Primary Outcome Measures :
  1. Central adiposity [ Time Frame: 6-8 weeks postpartum ]

Secondary Outcome Measures :
  1. Leptin levels [ Time Frame: during pregnancy and postpartum ]
  2. glucose [ Time Frame: during pregnancy and postpartum ]
  3. insulin [ Time Frame: during pregnancy and postpartum ]
  4. cholesterol [ Time Frame: during pregnancy and postpartum ]
  5. fetal adiposity [ Time Frame: 35-36 weeks gestation ]
  6. neonatal adiposity [ Time Frame: birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant women 18-45 years old receiving prenatal care at MAMC

Exclusion Criteria:

  • Women do not have a gallbladder
  • Who do not speak English
  • Are over 14 weeks pregnant at study entry
  • Do not plan to deliver at MAMC
  • Have medical contraindications
  • Unwilling to participate in exercise intervention program
  • Are under 18 years of age
  • Currently engaged in a regular vigorous exercise program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00647595

United States, Washington
Madigan Army Medical Center
Ft Lewis, Washington, United States, 98431
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Cynthia W Ko, MD MS University of Washington

Responsible Party: Lee, Sum P MD, Phd, Professor of Medicine, University of Washington School of Medicine Identifier: NCT00647595     History of Changes
Other Study ID Numbers: R03 DK74683 (completed)
NIH # 1 R03 DK074683-01A1
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: February 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Physical activity
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance