Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT01142804
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2010-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WalkLink: Internet-based Walking Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Environmental Factors', 'timeFrame': '9 months', 'description': 'Built and social environment factors'}], 'primaryOutcomes': [{'measure': 'Moderate Vigorous Activity', 'timeFrame': '9 months', 'description': 'Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers'}], 'secondaryOutcomes': [{'measure': 'Health Risk Factors', 'timeFrame': '9 months', 'description': 'Aerobic fitness, blood pressure, body mass index, body composition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Walking programs', 'Physical Activity', 'Behavior Modification', 'Social Support'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '27405724', 'type': 'DERIVED', 'citation': 'Rovniak LS, Kong L, Hovell MF, Ding D, Sallis JF, Ray CA, Kraschnewski JL, Matthews SA, Kiser E, Chinchilli VM, George DR, Sciamanna CN. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial. Ann Behav Med. 2016 Dec;50(6):885-897. doi: 10.1007/s12160-016-9814-8.'}, {'pmid': '23945138', 'type': 'DERIVED', 'citation': 'Rovniak LS, Sallis JF, Kraschnewski JL, Sciamanna CN, Kiser EJ, Ray CA, Chinchilli VM, Ding D, Matthews SA, Bopp M, George DR, Hovell MF. Engineering online and in-person social networks to sustain physical activity: application of a conceptual model. BMC Public Health. 2013 Aug 14;13:753. doi: 10.1186/1471-2458-13-753.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a randomized controlled trial based on the Social Networks for Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking program delivered to patients with risk factors for cardiovascular disease and stroke; and (2) the contribution of social support networks to enhancing the effectiveness of the internet-based fitness walking program. The investigators will recruit 308 patients who are sedentary and have risk factors for cardiovascular disease and randomly assign them to one of the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based fitness walking program plus additional social network intervention (WalkLink+); and 3. Minimal treatment control.\n\nThe primary specific aims of this study are to:\n\n1. Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control group on change in: physical activity, aerobic fitness, blood pressure, body composition, and body mass index (BMI), from baseline to posttest, and at 6-month follow-up.\n2. Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical activity, aerobic fitness, blood pressure, body composition and BMI from baseline to posttest, and at 6-month follow-up.\n3. Evaluate the mediator and moderator effects of selected individual-level self-management skills (goal setting, planning, self-monitoring), social support variables (number of activity partners, social cues for walking, social praise/reinforcement), and physical-ecological variables (neighborhood walkability, physical cues for walking) on WalkLink and WalkLink+ treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary, defined as less than 150 minutes per week of moderate intensity activity\n* Between the ages of 35 and 64\n* Able to speak English\n* Able to provide informed consent\n* Able to participate in moderate-intensity physical activity (e.g., moderate pace walking)\n\nExclusion Criteria:\n\n* No access to home or private work computer with Internet access\n* Body mass index (BMI) greater than 39.9\n* Systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg\n* Bone, joint, or foot problems that interfere with walking\n* Diabetes, pulmonary, or cardiovascular disease\n* Consume 5 or more drinks of alcohol a day\n* Currently pregnant\n* Not living within the preselected study neighborhoods or plan to move from the local area during the study period'}, 'identificationModule': {'nctId': 'NCT01142804', 'acronym': 'WalkLink', 'briefTitle': 'WalkLink: Internet-based Walking Program', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'WalkLink:Internet-based Walking Program for Cardiovascular Disease Risk-Reduction', 'orgStudyIdInfo': {'id': 'IRB-31708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care Group', 'description': 'Participants received weekly emailed tips of the week to provide support for walking.', 'interventionNames': ['Behavioral: Group']}, {'type': 'EXPERIMENTAL', 'label': 'WalkLink Group', 'description': 'Participants received weekly emailed tips of the week, plus evidence-based online fitness walking program.', 'interventionNames': ['Behavioral: Group']}, {'type': 'EXPERIMENTAL', 'label': 'WalkLink+ Group', 'description': 'Participants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention.', 'interventionNames': ['Behavioral: Group']}], 'interventions': [{'name': 'Group', 'type': 'BEHAVIORAL', 'otherNames': ['Enhanced Usual Care', 'WalkLink', 'WalkLink+'], 'description': 'Walking programs with various levels of support will be administered to determine which one is most effective.', 'armGroupLabels': ['Enhanced Usual Care Group', 'WalkLink Group', 'WalkLink+ Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Liza Rovniak, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine and Public Health Sciences', 'investigatorFullName': 'Liza Rovniak', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}