Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
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.
Behavioral: Experimental group
|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|
- Central adiposity [ Time Frame: 6-8 weeks postpartum ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647595
|United States, Washington|
|Madigan Army Medical Center|
|Ft Lewis, Washington, United States, 98431|
|Principal Investigator:||Cynthia W Ko, MD MS||University of Washington|