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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Pregnancy
• Intervention / Treatment: Behavioral: Experimental group

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Ft Lewis, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: B; Women in this group will continue their usual activities throughout their pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central adiposity	6-8 weeks postpartum

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Cynthia W Ko, MD MS, University of Washington

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: March 27, 2008
• First Submitted That Met QC Criteria: March 27, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Physical activity; Diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Metabolic Syndrome
• Other Study ID Numbers: R03 DK74683 (completed); NIH # 1 R03 DK074683-01A1