Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-02 @ 4:43 AM
Study NCT ID:
NCT00647595
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2008-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2008-03-27', 'studyFirstSubmitQcDate': '2008-03-27', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central adiposity', 'timeFrame': '6-8 weeks postpartum'}], 'secondaryOutcomes': [{'measure': 'Leptin levels', 'timeFrame': 'during pregnancy and postpartum'}, {'measure': 'glucose', 'timeFrame': 'during pregnancy and postpartum'}, {'measure': 'insulin', 'timeFrame': 'during pregnancy and postpartum'}, {'measure': 'cholesterol', 'timeFrame': 'during pregnancy and postpartum'}, {'measure': 'fetal adiposity', 'timeFrame': '35-36 weeks gestation'}, {'measure': 'neonatal adiposity', 'timeFrame': 'birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Physical activity', 'Pregnancy', 'Diabetes mellitus'], 'conditions': ['Obesity', 'Pregnancy', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women 18-45 years old receiving prenatal care at MAMC\n\nExclusion Criteria:\n\n* Women do not have a gallbladder\n* Who do not speak English\n* Are over 14 weeks pregnant at study entry\n* Do not plan to deliver at MAMC\n* Have medical contraindications\n* Unwilling to participate in exercise intervention program\n* Are under 18 years of age\n* Currently engaged in a regular vigorous exercise program'}, 'identificationModule': {'nctId': 'NCT00647595', 'briefTitle': 'Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome', 'orgStudyIdInfo': {'id': 'R03 DK74683 (completed)'}, 'secondaryIdInfos': [{'id': 'NIH # 1 R03 DK074683-01A1'}, {'id': 'R03DK074683', 'link': 'https://reporter.nih.gov/quickSearch/R03DK074683', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Behavioral: Experimental group']}, {'type': 'NO_INTERVENTION', 'label': 'B', 'description': 'Women in this group will continue their usual activities throughout their pregnancy.'}], 'interventions': [{'name': 'Experimental group', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98431', 'city': 'Joint Base Lewis McChord', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.10787, 'lon': -122.57694}}], 'overallOfficials': [{'name': 'Cynthia W Ko, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Lee, Sum P MD, Phd, Professor of Medicine', 'oldOrganization': 'University of Washington School of Medicine'}}}}