Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00242658
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2005-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Computerized Health Education to Promote Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cns10@psu.edu', 'phone': '717-531-8161', 'title': 'Chris Sciamanna, MD, MPH', 'organization': 'Penn State Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse events were collected by participants contacting the research team. Serious and/or other non-serious adverse events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Tailored Physical Activity Intervention Group', 'description': "The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.", 'otherNumAtRisk': 187, 'otherNumAffected': 0, 'seriousNumAtRisk': 187, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Tailored Physical Activity Intervention Group', 'description': 'The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.', 'otherNumAtRisk': 207, 'otherNumAffected': 0, 'seriousNumAtRisk': 207, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-Day Physical Activity Recall (7-Day PAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Physical Activity Intervention Group', 'description': "The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription."}, {'id': 'OG001', 'title': 'No Tailored Physical Activity Intervention Group', 'description': 'The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.85', 'groupId': 'OG000', 'lowerLimit': '6.45', 'upperLimit': '103.24'}, {'value': '44.89', 'groupId': 'OG001', 'lowerLimit': '3.19', 'upperLimit': '86.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral Processes of Change Between Baseline and 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Physical Activity Intervention Group', 'description': "The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription."}, {'id': 'OG001', 'title': 'No Tailored Physical Activity Intervention Group', 'description': 'The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.62'}, {'value': '0.18', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored Physical Activity Intervention Group', 'description': "The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription."}, {'id': 'FG001', 'title': 'No Tailored Physical Activity Intervention Group', 'description': 'The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored Physical Activity Intervention Group', 'description': "The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription."}, {'id': 'BG001', 'title': 'No Tailored Physical Activity Intervention Group', 'description': 'The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-07', 'studyFirstSubmitDate': '2005-10-19', 'resultsFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-04', 'studyFirstPostDateStruct': {'date': '2005-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-Day Physical Activity Recall (7-Day PAR)', 'timeFrame': '6 months', 'description': 'Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Change in Behavioral Processes of Change Between Baseline and 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Wellness Programs', 'Health Promotion', 'Blood Pressure, High'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '20621262', 'type': 'DERIVED', 'citation': 'Carroll JK, Lewis BA, Marcus BH, Lehman EB, Shaffer ML, Sciamanna CN. Computerized tailored physical activity reports. A randomized controlled trial. Am J Prev Med. 2010 Aug;39(2):148-56. doi: 10.1016/j.amepre.2010.04.005.'}]}, 'descriptionModule': {'briefSummary': "This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.", 'detailedDescription': "The main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians. The primary outcome is minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to speak and read English\n* Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate)\n* Ability to complete all written surveys\n* Accessible for follow-up telephone surveys\n* Ability to undergo exercise testing\n\nExclusion Criteria:\n\n* Currently participating in another research study\n* Planning to move out of the Philadelphia area\n* Unable to walk without pain\n* Pregnant or planning to become pregnant in the year following study entry\n* Excessive drinking\n* Coronary heart disease\n* Congestive heart failure\n* Peripheral vascular disease\n* Cerebrovascular disease\n* Chronic obstructive pulmonary disease\n* Arrhythmia\n* Recurrent seizures\n* Dizziness\n* Balance problems\n* Psychoses'}, 'identificationModule': {'nctId': 'NCT00242658', 'briefTitle': 'Computerized Health Education to Promote Physical Activity', 'nctIdAliases': ['NCT00201032'], 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Computerized Physical Activity Promotion in Primary Care', 'orgStudyIdInfo': {'id': '269'}, 'secondaryIdInfos': [{'id': '7R01HL067005-03', 'link': 'https://reporter.nih.gov/quickSearch/7R01HL067005-03', 'type': 'NIH'}, {'id': '02F.214 CHIP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Physical Activity Intervention Group', 'description': 'Four feedback reports aimed to increase physical activity.', 'interventionNames': ['Behavioral: Tailored Physical Activity Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No Tailored Physical Activity Intervention Group', 'description': 'General reports on preventive screening based on responses to preventive screening questions.'}], 'interventions': [{'name': 'Tailored Physical Activity Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise Intervention'], 'description': 'Tailored physical activity computer reports will be provided to patients and physicians.', 'armGroupLabels': ['Tailored Physical Activity Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Family Medicine Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Medical College, Department of Health Policy', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Christopher N. Sciamanna, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Jefferson Medical College, Department of Health Policy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Public Health Sciences', 'investigatorFullName': 'Christopher Sciamanna, MD, MPH', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}