Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 5:23 PM
Study NCT ID:
NCT01917812
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2013-08-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mActive: A Blinded, Randomized mHealth Activity Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smart100@jhmi.edu', 'phone': '410-955-7376', 'title': 'Dr. Seth S Martin', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Given its limited size and scope, mActive may be categorized as a pilot trial. As such, it is most appropriately interpreted as exploratory evidence to guide a definitive pivotal trial in the future.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Blinded Digital Activity Tracker', 'description': 'Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.\n\nBlinded Digital Activity Tracker', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Unblinded Digital Activity Tracker / No Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nUnblinded Digital Activity Tracker', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nSmart Text Messaging = Group receives personalized, health coaching via "smart" text messages.\n\nUnblinded Digital Activity Tracker\n\nSmart Text Messaging', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily Step Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}], 'classes': [{'categories': [{'measurements': [{'value': '-616', 'spread': '2385', 'groupId': 'OG000'}, {'value': '408', 'spread': '2701', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'steps per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Activity Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}], 'classes': [{'categories': [{'measurements': [{'value': '-6', 'spread': '26', 'groupId': 'OG000'}, {'value': '2', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Aerobic Activity Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}], 'classes': [{'categories': [{'measurements': [{'value': '-11', 'spread': '14', 'groupId': 'OG000'}, {'value': '-3', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Defined as the time spent walking continuously for \\>10 minutes without breaking for more than a minute.\n\nNote that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Daily Step Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}, {'id': 'OG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '-1042', 'spread': '2202', 'groupId': 'OG000'}, {'value': '-200', 'spread': '1653', 'groupId': 'OG001'}, {'value': '2334', 'spread': '1714', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'steps per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Activity Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}, {'id': 'OG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '-8', 'spread': '23', 'groupId': 'OG000'}, {'value': '0', 'spread': '17', 'groupId': 'OG001'}, {'value': '21', 'spread': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Aerobic Activity Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Blinded Digital Activity Tracker'}, {'id': 'OG001', 'title': 'Unblinded Digital Activity Tracker'}, {'id': 'OG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '10', 'groupId': 'OG000'}, {'value': '-1', 'spread': '8', 'groupId': 'OG001'}, {'value': '13', 'spread': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Blinded Digital Activity Tracker', 'description': 'Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.\n\nBlinded Digital Activity Tracker'}, {'id': 'FG001', 'title': 'Unblinded Digital Activity Tracker / No Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nNo Smart Text Messaging = Group does not receive personalized, health coaching via "smart" text messages.\n\nUnblinded Digital Activity Tracker'}, {'id': 'FG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nSmart Text Messaging = Group receives personalized, health coaching via "smart" text messages.\n\nUnblinded Digital Activity Tracker\n\nSmart Text Messaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We enrolled outpatients at an academic cardiovascular prevention center (Johns Hopkins Ciccarone Center) in Baltimore, Maryland, USA from January 17 to May 20, 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Blinded Digital Activity Tracker', 'description': 'Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.\n\nBlinded Digital Activity Tracker'}, {'id': 'BG001', 'title': 'Unblinded Digital Activity Tracker / No Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nUnblinded Digital Activity Tracker'}, {'id': 'BG002', 'title': 'Unblinded Digital Activity Tracker / Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nSmart Text Messaging = Group receives personalized, health coaching via "smart" text messages.\n\nUnblinded Digital Activity Tracker\n\nSmart Text Messaging'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '7', 'groupId': 'BG000'}, {'value': '58', 'spread': '8', 'groupId': 'BG001'}, {'value': '55', 'spread': '8', 'groupId': 'BG002'}, {'value': '58', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2013-08-01', 'resultsFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-01', 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Daily Step Count', 'timeFrame': 'Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}, {'measure': 'Mean Daily Step Count', 'timeFrame': 'Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}], 'secondaryOutcomes': [{'measure': 'Mean Daily Activity Time', 'timeFrame': 'Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}, {'measure': 'Mean Daily Aerobic Activity Time', 'timeFrame': 'Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)', 'description': 'Defined as the time spent walking continuously for \\>10 minutes without breaking for more than a minute.\n\nNote that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}, {'measure': 'Mean Daily Activity Time', 'timeFrame': 'Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}, {'measure': 'Mean Daily Aerobic Activity Time', 'timeFrame': 'Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)', 'description': 'Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical activity', 'exercise', 'mHealth', 'smartphone', 'activity tracker', 'pedometer', 'text messaging', 'SMS'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '26553211', 'type': 'RESULT', 'citation': 'Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.'}], 'seeAlsoLinks': [{'url': 'http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_472545.pdf', 'label': 'mActive: A Blinded, Randomized mHealth Trial Supporting Digital Tracking and Smart Texting for Promotion of Physical Activity. AHA EPI Scientific Sessions Presentation Slides.'}]}, 'descriptionModule': {'briefSummary': 'Despite their importance, health-related behaviors are hard to change. Among behaviors, physical activity is associated with protection from multiple diseases. People who are physically active have lower risk for heart disease, stroke, type 2 diabetes, depression, and some cancers with associated dose-dependent reductions in cardiovascular and all-cause mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary work behavior in industrialized nations is likely a contributor to this problem.\n\nCurrent low-technology strategies for encouraging lifestyle change are disappointingly ineffective and are highly resource intensive. Systematic reviews of the literature show mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence for text messaging in preventive health care. However, prior studies have not integrated digital activity tracking with mobile phone text messaging feedback.\n\nGiven 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this represents a potentially widely applicable avenue for therapeutic intervention. There is growing interest in leveraging mobile health (mHealth) technologies to improve health behaviors in the general population. The investigators propose to conduct a blinded, randomized mHealth trial of digital activity tracking and smart texting to promote physical activity.', 'detailedDescription': 'Using an innovative, convenient, mHealth trial design, this pilot study aims to test the feasibility of a seamless model of information flow integrating digital activity tracker information with a mobile phone texting system to deliver a technology-enhanced intervention that does not require in-person follow-up.\n\nThe investigators hypothesize that:\n\n1. individuals overestimate their physical activity, especially that done at work.\n2. biofeedback from an activity tracker can increase physical activity via increasing self-awareness.\n3. "smart" text message feedback can increase physical activity via personalizing health coaching.\n\nDigitalized activity tracking will use the Fitbug Orb, which syncs via Bluetooth with one\'s smartphone. It is a display-free triaxial accelerometer, allowing one to blind participants to numeric feedback. Text messaging will use Reify Health\'s "smart" platform for personalized, interactive texting by an automated and repeatable algorithm. Texting will be informed by real-time activity information.\n\nPotential advantages of the trial strategy include elimination of attendance at in-person sessions, personalization of health coaching, more continuous patient contact; inexpensive intervention, the ultimate ability to scale our intervention to larger target populations.\n\nAfter initial pilot trial completion, additional study will include long-term physical activity follow-up of participants and focus groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to cardiology clinic\n* Aged 18-69 years\n* User of a compatible smartphone\n\nExclusion Criteria:\n\n* Already using an activity tracker\n* Preferred form of activity is not measured by an activity tracker(swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading)\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting pulmonary disease, activity-limiting angina, activity-limiting osteoarthritis, or other condition.\n* 3 days or more of moderate or vigorous activity during leisure time for 30 minutes of more per day by International Physical Activity Questionnaire'}, 'identificationModule': {'nctId': 'NCT01917812', 'acronym': 'mActive', 'briefTitle': 'mActive: A Blinded, Randomized mHealth Activity Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'mActive: A Blinded, Randomized mHealth Trial of Digital Activity Tracking and Smart Texting to Promote Physical Activity', 'orgStudyIdInfo': {'id': 'NA_00086400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Blinded Digital Activity Tracker', 'description': 'Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.', 'interventionNames': ['Device: Digital Activity Tracker']}, {'type': 'EXPERIMENTAL', 'label': 'Unblinded Digital Activity Tracker / No Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nNo Smart Text Messaging = Group does not receive personalized, health coaching via "smart" text messages.\n\nNote that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'interventionNames': ['Device: Digital Activity Tracker']}, {'type': 'EXPERIMENTAL', 'label': 'Unblinded Digital Activity Tracker / Smart Text Messaging', 'description': 'Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.\n\nSmart Text Messaging = Group receives personalized, health coaching via "smart" text messages.\n\nNote that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.', 'interventionNames': ['Device: Digital Activity Tracker', 'Other: Smart Text Messaging']}], 'interventions': [{'name': 'Digital Activity Tracker', 'type': 'DEVICE', 'otherNames': ['Fitbug Orb'], 'armGroupLabels': ['Blinded Digital Activity Tracker', 'Unblinded Digital Activity Tracker / No Smart Text Messaging', 'Unblinded Digital Activity Tracker / Smart Text Messaging']}, {'name': 'Smart Text Messaging', 'type': 'OTHER', 'armGroupLabels': ['Unblinded Digital Activity Tracker / Smart Text Messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Michael J Blaha, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}