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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Pregnancy, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Experimental group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>|
| No Intervention: B<br>Women in this group will continue their usual activities throughout their pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central adiposity |  | 6-8 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leptin levels |  | during pregnancy and postpartum | 
| glucose |  | during pregnancy and postpartum | 
| insulin |  | during pregnancy and postpartum | 
| cholesterol |  | during pregnancy and postpartum | 
| fetal adiposity |  | 35-36 weeks gestation | 
| neonatal adiposity |  | birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Physical activity, Pregnancy, Diabetes mellitus