Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT00862602
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pedometers for Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': 'Pre-post'}, {'measure': 'Glucose tolerance', 'timeFrame': 'Pre-Post'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'Pre-post'}, {'measure': 'Step counts', 'timeFrame': 'Pre-Post'}, {'measure': 'Insulin', 'timeFrame': 'Pre-post'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GDM', 'gestational diabetes', 'pregnancy', 'diabetes', 'walking', 'exercise', 'pedometer', 'online'], 'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. Such a program is currently available for adults with chronic disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot and feasibility study of the program. The intervention will last 12 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational diabetes diagnosis within past three years\n* Access to computer with internet, USB port and Windows XP or Vista\n* Regular email user (weekly or more)\n* Can walk a block on her own\n* Sedentary (less than 150 minutes purposeful physical activity per week)\n\nExclusion Criteria:\n\n* Pregnancy\n* Unable to consent legally'}, 'identificationModule': {'nctId': 'NCT00862602', 'acronym': 'PEG', 'briefTitle': 'Pedometers for Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Type 2 Diabetes Risk in Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': 'K23DK071552', 'link': 'https://reporter.nih.gov/quickSearch/K23DK071552', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23DK071552', 'link': 'https://reporter.nih.gov/quickSearch/K23DK071552', 'type': 'NIH'}, {'id': 'R03DK083332', 'link': 'https://reporter.nih.gov/quickSearch/R03DK083332', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Stepping Up to Health', 'interventionNames': ['Behavioral: Stepping Up to Health']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Usual care group'}], 'interventions': [{'name': 'Stepping Up to Health', 'type': 'BEHAVIORAL', 'description': 'Internet-mediated pedometer-based intervention with gradually increasing goals and feedback on step counts. Also includes educational content targeted at women who have had gestational diabetes about exercise, diet \\& nutrition and prevention.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Catherine Kim, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Catherine Kim', 'investigatorAffiliation': 'University of Michigan'}}}}