Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-06 @ 6:10 PM
Study NCT ID:
NCT02360293
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2015-01-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
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': 'laura.damschroder@va.gov', 'phone': '734-845-3603', 'title': 'Laura Damschroder', 'organization': 'VA ORD'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Issue with device connectivity leading to missing data. PA is focused on proprietary measure of Active Minutes and any potential changes to how it is calculated by Fitbit are out of our control. Pain and Depression are self-reported measures.'}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.', 'eventGroups': [{'id': 'EG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 3, 'seriousNumAtRisk': 178, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 1, 'seriousNumAtRisk': 179, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Important Medical Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Important Medical Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Protocol Deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'OG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-67.1', 'groupId': 'OG000', 'lowerLimit': '-141.5', 'upperLimit': '7.35'}, {'value': '-69.0', 'groupId': 'OG001', 'lowerLimit': '-148.1', 'upperLimit': '10.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '-119.0', 'ciUpperLimit': '122.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '46.2', 'estimateComment': 'Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.', 'groupDescription': 'Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline in objectively monitored physical activity at one year after randomization', 'description': 'Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.', 'unitOfMeasure': 'Active minutes/week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population decreases with time, at 12-month follow-up: SS+coaching 68; SS 58.'}, {'type': 'SECONDARY', 'title': 'Change in Weight as Measured From VA Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'OG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.121', 'groupId': 'OG000', 'lowerLimit': '-7.25', 'upperLimit': '7.01'}, {'value': '4.902', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '11.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.02', 'ciLowerLimit': '-15.85', 'ciUpperLimit': '5.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '56.7', 'estimateComment': 'Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.', 'groupDescription': 'The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline in weight at one year after randomization', 'description': "Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale.", 'unitOfMeasure': 'weight by pounds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to missing data from study provided scale, EHR weight was pulled for all patients, however, roughly half of the population lacked EHR weights within the time-frame of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'OG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.410', 'groupId': 'OG000', 'lowerLimit': '-1.510', 'upperLimit': '0.690'}, {'value': '0.752', 'groupId': 'OG001', 'lowerLimit': '-0.442', 'upperLimit': '1.946'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.162', 'ciLowerLimit': '-2.969', 'ciUpperLimit': '0.646', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.690', 'estimateComment': 'Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.', 'groupDescription': 'The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline Depression score at one year after randomization', 'description': 'The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population decreases with time, at 12-month follow-up: SS+coaching 96; SS 81.'}, {'type': 'SECONDARY', 'title': 'Change in Pain Measures as Assessed by the VA Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'OG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.212', 'groupId': 'OG000', 'lowerLimit': '-0.215', 'upperLimit': '0.639'}, {'value': '0.557', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '1.018'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.345', 'ciLowerLimit': '-1.044', 'ciUpperLimit': '0.353', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.267', 'estimateComment': 'Estimate generated through ANCOVA predicting "Pain In Past Week" as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline..', 'groupDescription': 'The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline in Pain measures at one year after randomization', 'description': 'Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population decreases with time, at 12-month follow-up: SS+coaching 101; SS 84.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'FG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': '6month f/u Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': '6month Physical Activity', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': '12month f/u Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': '12month Physical Activity', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '96'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Excluded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Letters were mailed to potential participants. They used the information in the recruitment letter to accessed an online portal and respond to screening question. If eligible, they completed the consent documentation, baseline questionnaire, downloaded and registered the Stay Strong App. Recruitment period was from 10/1/2017 - 4/30/2018.', 'preAssignmentDetails': 'After consent and prior to randomization participants were to completed baseline survey, register app, and complete a baseline physical activity (PA) period for randomization. 56 participants were excluded due to failure to complete baseline survey or register app. 52 participants were excluded due to failure to provide baseline PA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stay Strong w/Coaching', 'description': 'Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.\n\nStay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.'}, {'id': 'BG001', 'title': 'Stay Strong', 'description': 'Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.\n\nStay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitbit-Captured Active Minutes/Week, Median', 'classes': [{'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '328'}, {'value': '190', 'groupId': 'BG001', 'lowerLimit': '83', 'upperLimit': '354'}, {'value': '178', 'groupId': 'BG002', 'lowerLimit': '80', 'upperLimit': '346'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Active minutes/week', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fitbit-captured steps/day, mean', 'classes': [{'categories': [{'measurements': [{'value': '7571', 'spread': '3464', 'groupId': 'BG000'}, {'value': '8163', 'spread': '3978', 'groupId': 'BG001'}, {'value': '7867', 'spread': '3737', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Steps/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Depression scale (PHQ-8), Median', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'Lower Scores Indicate a Better Outcome, Range: 0-24', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pain Intensity >=4', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PHQ-8 - Clinically Significant Depression', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-18', 'size': 356113, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-05T14:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2015-01-14', 'resultsFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device', 'timeFrame': 'Change from Baseline in objectively monitored physical activity at one year after randomization', 'description': 'Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.'}], 'secondaryOutcomes': [{'measure': 'Change in Weight as Measured From VA Medical Record', 'timeFrame': 'Change from Baseline in weight at one year after randomization', 'description': "Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale."}, {'measure': 'Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)', 'timeFrame': 'Change from Baseline Depression score at one year after randomization', 'description': 'The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24'}, {'measure': 'Change in Pain Measures as Assessed by the VA Pain Intensity', 'timeFrame': 'Change from Baseline in Pain measures at one year after randomization', 'description': 'Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'App-mediated', 'Veterans'], 'conditions': ['Exercise']}, 'referencesModule': {'references': [{'pmid': '30694208', 'type': 'RESULT', 'citation': 'Buis LR, McCant FA, Gierisch JM, Bastian LA, Oddone EZ, Richardson CR, Kim HM, Evans R, Hooks G, Kadri R, White-Clark C, Damschroder LJ. Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. JMIR Res Protoc. 2019 Jan 29;8(1):e12526. doi: 10.2196/12526.'}, {'pmid': '32913914', 'type': 'DERIVED', 'citation': 'Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.'}, {'pmid': '32687474', 'type': 'DERIVED', 'citation': 'Damschroder LJ, Buis LR, McCant FA, Kim HM, Evans R, Oddone EZ, Bastian LA, Hooks G, Kadri R, White-Clark C, Richardson CR, Gierisch JM. Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial. J Med Internet Res. 2020 Aug 4;22(8):e19216. doi: 10.2196/19216.'}, {'pmid': '30681965', 'type': 'DERIVED', 'citation': 'Buis LR, Dawood K, Kadri R, Dawood R, Richardson CR, Djuric Z, Sen A, Plegue M, Hutton D, Brody A, McNaughton CD, Brook RD, Levy P. Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e12601. doi: 10.2196/12601.'}]}, 'descriptionModule': {'briefSummary': 'This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.\n\nThis project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.', 'detailedDescription': 'Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese. However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts. Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations. When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system. Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans. Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals. Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. OEF/OIF/OND Veteran\n2. Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system\n3. Interested in starting a physical activity program in the next 30 days\n4. Access to a computer with an internet connection and a working USB port.\n5. A smartphone running a compatible iOS or Android operating system.\n6. Younger than Age 65\n\nExclusion Criteria:\n\n1. Veteran self-reports that a health care provider has told the patient that it is currently unsafe to exercise in an unsupervised or unmonitored setting. (Can become eligible with written medical clearance).\n2. History of eating disorders or a BMI \\< 20\n3. Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.'}, 'identificationModule': {'nctId': 'NCT02360293', 'briefTitle': 'Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans', 'orgStudyIdInfo': {'id': 'CRE 12-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stay Strong w/coaching', 'description': 'participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.', 'interventionNames': ['Behavioral: Stay Strong w/coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stay Strong', 'description': 'participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.', 'interventionNames': ['Behavioral: Stay Strong']}], 'interventions': [{'name': 'Stay Strong w/coaching', 'type': 'BEHAVIORAL', 'description': 'Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.', 'armGroupLabels': ['Stay Strong w/coaching']}, {'name': 'Stay Strong', 'type': 'BEHAVIORAL', 'description': 'Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.', 'armGroupLabels': ['Stay Strong']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Laura J. Damschroder, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}