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

NCT ID: NCT00647595

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-12-31

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.

Conditions

Obesity; Pregnancy; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

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.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: BEHAVIORAL

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.

B

Women in this group will continue their usual activities throughout their pregnancy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

University of Washington School of Medicine

Principal Investigators

Cynthia W Ko, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, United States

Countries

United States

Other Identifiers

NIH # 1 R03 DK074683-01A1

Identifier Type: -

Identifier Source: secondary_id

R03DK074683

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03 DK74683 (completed)

Identifier Type: -

Identifier Source: org_study_id