Clinical trial NCT00647595: Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Official title: Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Pregnancy
Diabetes Mellitus
Keywords: Obesity
Physical activity
Pregnancy
Diabetes mellitus
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2008-03-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Central adiposity
timeFrame: 6-8 weeks postpartum
Secondary outcomes:
measure: Leptin levels
timeFrame: during pregnancy and postpartum
measure: glucose
timeFrame: during pregnancy and postpartum
measure: insulin
timeFrame: during pregnancy and postpartum
measure: cholesterol
timeFrame: during pregnancy and postpartum
measure: fetal adiposity
timeFrame: 35-36 weeks gestation
measure: neonatal adiposity
timeFrame: birth
Other outcomes:
Locations:
city: Ft Lewis
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia W Ko, MD MS
role: PRINCIPAL_INVESTIGATOR
References: