Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT00970294
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2009-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Project of Health Promotion for People With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pkluding@kumc.edu', 'phone': '913-588-6918', 'title': 'Patricia Kluding PT PhD', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment, Retention, Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks', 'description': '% of enrolled subjects who completed the trial', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aerobic Fitness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '1.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at 10 weeks (change score)', 'description': 'peak VO2 as measured with a graded maximal exercise test on a cycle ergometer', 'unitOfMeasure': 'mL/kg/m', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glycemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at 10 weeks (change score)', 'description': 'HbA1c measure', 'unitOfMeasure': 'percentage of glycosolated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2009-09-01', 'resultsFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-18', 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment, Retention, Adherence', 'timeFrame': '10 weeks', 'description': '% of enrolled subjects who completed the trial'}], 'secondaryOutcomes': [{'measure': 'Aerobic Fitness', 'timeFrame': 'Baseline and at 10 weeks (change score)', 'description': 'peak VO2 as measured with a graded maximal exercise test on a cycle ergometer'}, {'measure': 'Glycemic Control', 'timeFrame': 'Baseline and at 10 weeks (change score)', 'description': 'HbA1c measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '20530663', 'type': 'RESULT', 'citation': 'Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diabetes type II\n2. age 40-70\n\nExclusion Criteria:\n\n1. hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months\n2. significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus\n3. recent symptoms of chest discomfort\n4. currently smoking or significant pulmonary pathology\n5. serious musculoskeletal problems that would limit ability to exercise\n6. current active involvement in a regular exercise program (\\> 3 times per week)\n7. open wounds on the weight bearing surface of the feet\n8. not able to ambulate independently\n9. stroke or other central nervous system pathology\n10. stage 2 hypertension (resting blood pressure \\> 160 systolic or \\> 100 diastolic)'}, 'identificationModule': {'nctId': 'NCT00970294', 'briefTitle': 'Pilot Project of Health Promotion for People With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '10946'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health Promotion Program', 'description': 'Supervised exercise, educational sessions, dietary counseling', 'interventionNames': ['Behavioral: Health Promotion Program']}], 'interventions': [{'name': 'Health Promotion Program', 'type': 'BEHAVIORAL', 'description': '10 week health promotion program 3-4 times per week', 'armGroupLabels': ['Health Promotion Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Patricia Kluding PhD', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Patricia Kluding, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patricia Kluding, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Patricia Kluding, PhD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}