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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00647595
First received: March 27, 2008
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Obesity
Pregnancy
Diabetes Mellitus
Behavioral: Experimental group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Central adiposity [ Time Frame: 6-8 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leptin levels [ Time Frame: during pregnancy and postpartum ] [ Designated as safety issue: No ]
  • glucose [ Time Frame: during pregnancy and postpartum ] [ Designated as safety issue: No ]
  • insulin [ Time Frame: during pregnancy and postpartum ] [ Designated as safety issue: No ]
  • cholesterol [ Time Frame: during pregnancy and postpartum ] [ Designated as safety issue: No ]
  • fetal adiposity [ Time Frame: 35-36 weeks gestation ] [ Designated as safety issue: No ]
  • neonatal adiposity [ Time Frame: birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00647595

Locations
United States, Washington
Madigan Army Medical Center
Ft Lewis, Washington, United States, 98431
Sponsors and Collaborators
Investigators
Principal Investigator: Cynthia W Ko, MD MS University of Washington
  More Information

No publications provided

Responsible Party: Lee, Sum P MD, Phd, Professor of Medicine, University of Washington School of Medicine
ClinicalTrials.gov Identifier: NCT00647595     History of Changes
Other Study ID Numbers: R03 DK74683 (completed), NIH # 1 R03 DK074683-01A1
Study First Received: March 27, 2008
Last Updated: February 24, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on October 16, 2014