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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647595
• Other study ID #: R03 DK74683 (completed)
• Secondary ID: NIH # 1 R03 DK07
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2008
• Last updated: April 21, 2015
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome X
• Obesity
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Ft Lewis	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central adiposity		6-8 weeks postpartum	No
Secondary	Leptin levels		during pregnancy and postpartum	No
Secondary	glucose		during pregnancy and postpartum	No
Secondary	insulin		during pregnancy and postpartum	No
Secondary	cholesterol		during pregnancy and postpartum	No
Secondary	fetal adiposity		35-36 weeks gestation	No
Secondary	neonatal adiposity		birth	No