Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT01469260
Status:
TERMINATED
Last Update Posted:
2021-09-21
First Post:
2011-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2014-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excessive gestational weight gain', 'timeFrame': 'At delivery', 'description': 'Gestational weight gain greater than Institute of Medicine recommendations'}], 'secondaryOutcomes': [{'measure': 'Postpartum weight', 'timeFrame': '6 weeks postpartum'}, {'measure': 'Weight at 1 year postpartum', 'timeFrame': '1 year postpartum'}, {'measure': 'Gestational diabetes', 'timeFrame': 'During pregnancy'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '24-28 weeks gestation'}, {'measure': 'Infant birth weight', 'timeFrame': 'At delivery'}, {'measure': 'Mode of delivery', 'timeFrame': 'At delivery'}, {'measure': 'Hypertensive disorders of pregnancy', 'timeFrame': 'During pregnancy'}, {'measure': 'Neonatal intensive care unit admission or neonatal complications', 'timeFrame': 'Up to 1 week after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Pregnancy', 'Weight gain', 'Pedometer', 'Exercise'], 'conditions': ['Overweight', 'Obesity', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Pregnant\n* Less than 16 weeks gestation\n* Body mass index 25 or greater at first prenatal visit\n\nExclusion Criteria:\n\n* History of spontaneous preterm delivery between 20-32 weeks gestation\n* Medical contraindication to exercise or walking during pregnancy'}, 'identificationModule': {'nctId': 'NCT01469260', 'briefTitle': 'Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women', 'orgStudyIdInfo': {'id': '22651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': 'ACOG Exercise in Pregnancy pamphlet'}, {'type': 'EXPERIMENTAL', 'label': 'Pedometer', 'description': 'ACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day', 'interventionNames': ['Other: Pedometer']}], 'interventions': [{'name': 'Pedometer', 'type': 'OTHER', 'description': 'Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise', 'armGroupLabels': ['Pedometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Obstetrics Clinic", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Susan Crowe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Joyce Sung, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': "Lucile Packard Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Susan D Crowe', 'investigatorAffiliation': 'Stanford University'}}}}