Expired Study
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Ft Lewis, Washington 98431


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

R03 DK74683 (completed)


NCT ID:

NCT00647595


Secondary ID:

NIH # 1 R03 DK074683-01A1


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Cynthia W Ko, MD MS
Principal Investigator
University of Washington

Study Dates

Start Date:October 2007
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:April 21, 2015
First Received Date:March 27, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:neonatal adiposity
Time Frame:birth
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:fetal adiposity
Time Frame:35-36 weeks gestation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:cholesterol
Time Frame:during pregnancy and postpartum
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:insulin
Time Frame:during pregnancy and postpartum
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:glucose
Time Frame:during pregnancy and postpartum
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Leptin levels
Time Frame:during pregnancy and postpartum
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Central adiposity
Time Frame:6-8 weeks postpartum
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Experimental group
Description: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.
Arm Name:A

Study Arms

Study Arm Type:No Intervention
Arm Name:B
Description:Women in this group will continue their usual activities throughout their pregnancy.
Study Arm Type:Experimental
Arm Name:A
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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