Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Primary Purpose
Obesity, Pregnancy, Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Experimental group
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Physical activity, Pregnancy, Diabetes mellitus
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
Sites / Locations
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm 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.
Women in this group will continue their usual activities throughout their pregnancy.
Outcomes
Primary Outcome Measures
Central adiposity
Secondary Outcome Measures
Leptin levels
glucose
insulin
cholesterol
fetal adiposity
neonatal adiposity
Full Information
NCT ID
NCT00647595
First Posted
March 27, 2008
Last Updated
April 21, 2015
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00647595
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy, Diabetes Mellitus
Keywords
Obesity, Physical activity, Pregnancy, Diabetes mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
No Intervention
Arm Description
Women in this group will continue their usual activities throughout their pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Experimental group
Intervention 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.
Primary Outcome Measure Information:
Title
Central adiposity
Time Frame
6-8 weeks postpartum
Secondary Outcome Measure Information:
Title
Leptin levels
Time Frame
during pregnancy and postpartum
Title
glucose
Time Frame
during pregnancy and postpartum
Title
insulin
Time Frame
during pregnancy and postpartum
Title
cholesterol
Time Frame
during pregnancy and postpartum
Title
fetal adiposity
Time Frame
35-36 weeks gestation
Title
neonatal adiposity
Time Frame
birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia W Ko, MD MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madigan Army Medical Center
City
Ft Lewis
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
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