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

Phase 3

Completed

• Conditions: Obesity; Pregnancy; Diabetes Mellitus
• Interventions: Behavioral: Experimental group

• Registration Number: NCT00647595
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-31
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-02
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Experimental group	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.

Primary Outcome Measures

Name	Time	Method
Central adiposity	6-8 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
neonatal adiposity	birth
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

Trial Locations

Locations (1)

Madigan Army Medical Center; 🇺🇸 Ft Lewis, Washington, United States