Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03538158
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Personalized Health Behavior System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cob2014@med.cornell.edu', 'phone': '212-746-1417', 'title': 'Chelsie Burchett', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The 6 months the participant was enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.\n\nIntervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 4, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Control Condition - Paper and Pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.\n\nControl Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 5, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Heart surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'VO2 Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.\n\nIntervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.'}, {'id': 'OG001', 'title': 'Control Condition - Paper and Pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.\n\nControl Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': '3 month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': '6 month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-287.7', 'ciUpperLimit': '299.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,131)=.07'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score of VO2 max indicates more oxygen consumption during incremental exercise.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is different than the number of subjects in the participant flow because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'type': 'SECONDARY', 'title': 'Timed Up and Go', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.\n\nIntervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.'}, {'id': 'OG001', 'title': 'Control Condition - Paper and Pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.\n\nControl Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '3', 'groupId': 'OG000'}, {'value': '10', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.5', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '4.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,75)=.03'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides.\n\nThe test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down.\n\nThe recorded time on the stopwatch is the TUG score. Measure to assess mobility. A faster time indicates a better functional performance.\n\nAn older adult who takes ≥12 seconds to complete the TUG is at risk for falling.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is different than the number of subjects in the participant flow because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Functional Health and Well-being as Measured by Modified SF-36', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score means better functional health and well-being. Range (0-1400)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Loneliness as Measured by Loneliness Scale', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score indicates a greater degree of loneliness. Range (0-80)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Social Isolation as Measured by Friendship Scale', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Measures the level of functional social support. Higher scores indicates better and more social support', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.\n\nIntervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.'}, {'id': 'FG001', 'title': 'Control Condition - Paper and Pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.\n\nControl Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': '12 Week Intervention Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': '12 Week Maintenance Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.\n\nIntervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.'}, {'id': 'BG001', 'title': 'Control Condition - Paper and Pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.\n\nControl Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}], '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': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'VO2 Max', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '16.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '16.7', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}, {'title': 'Timed Up and Go', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '3', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides.\n\nThe test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down.\n\nThe recorded time on the stopwatch is the TUG score.\n\nMeasure to assess mobility. A faster time indicates a better functional performance.\n\nAn older adult who takes ≥12 seconds to complete the TUG is at risk for falling.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-22', 'size': 298629, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-04T12:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2018-05-15', 'resultsFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-14', 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Functional Health and Well-being as Measured by Modified SF-36', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score means better functional health and well-being. Range (0-1400)'}, {'measure': 'Change in Loneliness as Measured by Loneliness Scale', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score indicates a greater degree of loneliness. Range (0-80)'}, {'measure': 'Change in Social Isolation as Measured by Friendship Scale', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24)'}, {'measure': 'Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Measures the level of functional social support. Higher scores indicates better and more social support'}], 'primaryOutcomes': [{'measure': 'VO2 Max', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'Higher score of VO2 max indicates more oxygen consumption during incremental exercise.'}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go', 'timeFrame': 'Baseline, 3 month follow-up and 6 month follow-up', 'description': 'To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides.\n\nThe test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down.\n\nThe recorded time on the stopwatch is the TUG score. Measure to assess mobility. A faster time indicates a better functional performance.\n\nAn older adult who takes ≥12 seconds to complete the TUG is at risk for falling.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older adults', 'Physical well-being', 'Quality of life'], 'conditions': ['Social Isolation', 'Aging', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '38902616', 'type': 'DERIVED', 'citation': 'Lieber SB, Moxley J, Mandl LA, Reid MC, Czaja SJ. Social support and physical activity: does general health matter? Eur Rev Aging Phys Act. 2024 Jun 20;21(1):16. doi: 10.1186/s11556-024-00347-6.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to examine the usability and efficacy, for diverse older adults, of a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals.\n\nThe proposed study involves a two group randomized trial where participants will be randomized to the Fittle Senior System or to a paper-based psycho-educational control condition following a baseline assessment. The duration of the intervention phase will involve an active 12-week intervention phase followed by a 12-week maintenance phase. We will recruit and randomize 180 community dwelling adults aged 65+ years, who live alone and are at risk for social isolation. Participants will be assessed at baseline, 3 months post active intervention and 3 months post maintenance (6 months following active intervention) on measures of health and health behaviors, and indices of social support.', 'detailedDescription': 'The proposed study will evaluate a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized, goal-directed behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals. The system builds on two technology-based systems developed by the investigative team: (1) the computer-based PRISM system (Czaja et al., 2015), designed for older populations to support social connectivity and well-being, and (2) the Fittle mobile platform (PARC) designed to support positive health behavior change through integrated online social support and personalized coaching based on artificial intelligence (AI). The Fittle program is based on Self-efficacy and Social Cognitive Theory (Bandura, 1998, 2001), Goal Setting (Locke \\& Latham, 2002) and the Theory of Planned Behavior (Ajzen, 1991). Fittle provides support for individuals and teams to progress through lifestyle challenges (e.g., poor eating habits, sedentary behavior), helping individuals master one health improving habit after another in a way that builds on previous achievements. Individuals choose from a variety of challenges to accomplish goals via an intelligent coaching agent and personalized, engaging user experiences. The objective is to maintain and reinforce perceived self-efficacy with daily goals that are perceived as being achievable, and to improve motivation and ability with goals that are perceived as not too easy. The program provides encouragement and social support through a team component. Thus, Fittle is designed to reinforce and build self-efficacy and positive attitudes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 60 years old\n* Speak English\n* Able to read at the 6th grade\n* Plans to remain in the area for the study duration\n* Pass TICS (Telephone Screen for Cognitive Status)\n\nExclusion Criteria:\n\n* Cognitively impaired\n* Visual or hearing impairment\n* Actively engaged in structured physical exercise regularly\n* Health conditions/illness that would affect participation'}, 'identificationModule': {'nctId': 'NCT03538158', 'acronym': 'FITTLESenior', 'briefTitle': 'A Personalized Health Behavior System', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)', 'orgStudyIdInfo': {'id': '1806019352'}, 'secondaryIdInfos': [{'id': 'R01AG053163', 'link': 'https://reporter.nih.gov/quickSearch/R01AG053163', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention condition - Fittle Senior', 'description': 'Participants will have access to the Fittle Senior System which will provide guided exercises and social support.', 'interventionNames': ['Behavioral: Intervention Condition']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control condition - paper and pencil', 'description': 'Participants will have a written booklet with exercises that they may do it on their own.', 'interventionNames': ['Behavioral: Control Condition']}], 'interventions': [{'name': 'Intervention Condition', 'type': 'BEHAVIORAL', 'description': 'Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.', 'armGroupLabels': ['Intervention condition - Fittle Senior']}, {'name': 'Control Condition', 'type': 'BEHAVIORAL', 'description': 'Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.', 'armGroupLabels': ['Control condition - paper and pencil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sara J. Czaja, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will become available following the publication of the primary outcomes paper and will be available at request for 5 years.', 'ipdSharing': 'YES', 'description': 'IPD will be shared with investigators upon request. This data will include sociodemographic data and outcome measures including SF-36, Loneliness Scale, Friendship Scale and Interpersonal Support Evaluation List (ISEL) scores. IPD will be free from any Personal Health Identifiers.', 'accessCriteria': 'Data will be available to investigators at request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Florida Institute for Human and Machine Cognition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}