Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02554435
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TAME Health: Testing Activity Monitors' Effect on Health
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': 'drkoyyalewis@gmail.com', 'phone': '5628819950', 'title': 'Dr. Zakkoyya Lewis', 'organization': 'California State Polytechnic University, Pomona'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.", 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Knee replacement', 'notes': 'Two participants had knee replacement surgery after consenting to the study, but their participation in the study did not start until they completed physical therapy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stones', 'notes': 'Participant was admitted to the hospital for kidney stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse reaction', 'notes': 'Participant had an adverse reaction to physician prescribed medication for a chronic illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Activity Minutes Measured by a SenseWear Armband', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '27.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Physical activity minutes at the end of the 12 week intervention', 'description': 'Minutes of moderate-vigorous physical activity over a 7 day period', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cardiovascular risk at the end of the 12 week intervention', 'description': "Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \\>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \\>30% risk of a cardiovascular event within the next 10 years.", 'unitOfMeasure': 'Risk score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '6-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '1642.9', 'spread': '287.3', 'groupId': 'OG000'}, {'value': '1561', 'spread': '353.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Fitness at the end of the 12 week intervention', 'description': 'distance walked in 6 minutes', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Steps Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '4702', 'spread': '2259.7', 'groupId': 'OG000'}, {'value': '4353', 'spread': '2021.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Steps per day at the end of the 12 week intervention', 'description': 'Measured by a SenseWear Armband. Average steps per day over a 7 day period', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weight at the end of the 12 week intervention', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BMI at the end of the 12 week intervention', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist-to-Hip Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '.84', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Waist-to-hip ratio at the end of the 12 week intervention', 'description': 'Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '134.3', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '125.0', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '83.4', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '80', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood pressure at the end of the 12 week intervention', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exercise Motivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Intrinsic', 'categories': [{'measurements': [{'value': '1.48', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Identified', 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Introjected', 'categories': [{'measurements': [{'value': '1.12', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Extrinsic', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Amotivation', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Exercise motivation at the end of the 12 week intervention', 'description': 'Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of "intrinsic" and "identified" are better. Alternatively, low scores of "introjected", "extrinsic", and "amotivation" are better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measured by the SF-36 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Physical functioning', 'categories': [{'measurements': [{'value': '62.3', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning', 'categories': [{'measurements': [{'value': '75.8', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '31.4', 'groupId': 'OG001'}]}]}, {'title': 'Physical role limitations', 'categories': [{'measurements': [{'value': '67.9', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Emotional role limitations', 'categories': [{'measurements': [{'value': '75.8', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '31.4', 'groupId': 'OG001'}]}]}, {'title': 'Mental health', 'categories': [{'measurements': [{'value': '70', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Energy/vitality', 'categories': [{'measurements': [{'value': '53.1', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '56.8', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '60.3', 'spread': '26.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Quality of life at the end of the 12 week intervention', 'description': 'Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Function Measured by the Short Physical Performance Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Chair stand', 'categories': [{'measurements': [{'value': '14.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Tandem balance', 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '8 feet up and go', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Physical function at the end of the 12 week intervention', 'description': 'Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled "tandem balance."', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psychological Feelings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Competence', 'categories': [{'measurements': [{'value': '2.49', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'measurements': [{'value': '3.16', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Relatedness', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Psychological feelings at the end of the 12 week intervention', 'description': 'Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Resting pulse at the end of the 12 week intervention', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Self-regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'OG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the'}], 'classes': [{'title': 'Goal-setting', 'categories': [{'measurements': [{'value': '22.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Planning', 'categories': [{'measurements': [{'value': '24.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in self-regulation from baseline and 12-weeks', 'description': 'Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'FG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.\n\n5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.\n\nPedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days."}, {'id': 'BG001', 'title': 'Electronic Activity Monitor', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.\n\nEAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.\n\n5 A\'s counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '33.9', 'groupId': 'BG000'}, {'value': '22.5', 'spread': '21.5', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '29.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Physical activity was defined as the minutes of moderate to vigorous physical activity as measured by the Sensewear Armband.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Steps', 'classes': [{'categories': [{'measurements': [{'value': '4560.18', 'spread': '2285.6', 'groupId': 'BG000'}, {'value': '3849.4', 'spread': '2107.8', 'groupId': 'BG001'}, {'value': '4204.8', 'spread': '2199.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'steps per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2015-08-24', 'resultsFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-06', 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Minutes Measured by a SenseWear Armband', 'timeFrame': 'Physical activity minutes at the end of the 12 week intervention', 'description': 'Minutes of moderate-vigorous physical activity over a 7 day period'}, {'measure': 'Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator', 'timeFrame': 'Cardiovascular risk at the end of the 12 week intervention', 'description': "Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \\>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \\>30% risk of a cardiovascular event within the next 10 years."}, {'measure': '6-minute Walk Test', 'timeFrame': 'Fitness at the end of the 12 week intervention', 'description': 'distance walked in 6 minutes'}, {'measure': 'Steps Per Day', 'timeFrame': 'Steps per day at the end of the 12 week intervention', 'description': 'Measured by a SenseWear Armband. Average steps per day over a 7 day period'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Weight at the end of the 12 week intervention'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'BMI at the end of the 12 week intervention'}, {'measure': 'Waist-to-Hip Ratio', 'timeFrame': 'Waist-to-hip ratio at the end of the 12 week intervention', 'description': 'Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).'}, {'measure': 'Blood Pressure', 'timeFrame': 'Blood pressure at the end of the 12 week intervention'}, {'measure': 'Exercise Motivation', 'timeFrame': 'Exercise motivation at the end of the 12 week intervention', 'description': 'Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of "intrinsic" and "identified" are better. Alternatively, low scores of "introjected", "extrinsic", and "amotivation" are better.'}, {'measure': 'Quality of Life Measured by the SF-36 Questionnaire', 'timeFrame': 'Quality of life at the end of the 12 week intervention', 'description': 'Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.'}, {'measure': 'Physical Function Measured by the Short Physical Performance Battery', 'timeFrame': 'Physical function at the end of the 12 week intervention', 'description': 'Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled "tandem balance."'}, {'measure': 'Psychological Feelings', 'timeFrame': 'Psychological feelings at the end of the 12 week intervention', 'description': 'Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.'}, {'measure': 'Resting Pulse', 'timeFrame': 'Resting pulse at the end of the 12 week intervention'}, {'measure': 'Change From Baseline in Self-regulation', 'timeFrame': 'Change in self-regulation from baseline and 12-weeks', 'description': 'Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.'}]}, 'conditionsModule': {'keywords': ['physical activity', 'activity monitor', 'older adults', "5 A's counseling"], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '27129602', 'type': 'BACKGROUND', 'citation': "Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Lyons EJ. Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients. JMIR Res Protoc. 2016 Apr 29;5(2):e59. doi: 10.2196/resprot.5454."}, {'pmid': '32961834', 'type': 'DERIVED', 'citation': 'Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial. Int J Environ Res Public Health. 2020 Sep 18;17(18):6800. doi: 10.3390/ijerph17186800.'}, {'pmid': '28807041', 'type': 'DERIVED', 'citation': 'Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. The feasibility and RE-AIM evaluation of the TAME health pilot study. Int J Behav Nutr Phys Act. 2017 Aug 14;14(1):106. doi: 10.1186/s12966-017-0560-5.'}], 'seeAlsoLinks': [{'url': 'http://www.researchprotocols.org/2016/2/e59/', 'label': 'TAME health protocol citation'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.', 'detailedDescription': "Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in maintaining cardiovascular health, but older adults are inactive. Inactivity may be influenced by low levels of motivation. Standard behavioral counseling techniques typically implemented within the primary care setting target increased motivation, but lack the key component of self-control. The addition of electronic activity monitors (EAMs) that provide interactive self-monitoring, feedback, and social support may further increase motivation for exercise by providing more effective behavior change techniques than standard protocols. Investigators will conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (N = 40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Investigators propose two Specific Aims:\n\nAIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief intervention to increase physical activity in a primary care setting. Measures of feasibility will include days the EAM was worn, usage of the app, technological problems, attrition, and adverse events. Acceptability will be measured by self-report and focus groups.\n\nAIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also investigate secondary outcomes (differences in adherence, weight and body composition, health status, motivation, physical function, psychological feelings, self-regulation)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically inactive (less than 60 minutes per week)\n* BMI between 25-35\n* in good health measured by Par-Q+\n* access to a smart phone\n\nExclusion Criteria:\n\n* physical activity is inadvisable by their doctor\n* involved in another physical activity intervention within the past 6 months\n* used an activity monitor in the past 6 months\n* unwilling to travel for scheduled visits\n* currently taking medications that affect body composition\n* current smoker\n* report alcohol or drug problem\n* institutionalized for psychiatric illness within the last year\n* do not consent'}, 'identificationModule': {'nctId': 'NCT02554435', 'briefTitle': "TAME Health: Testing Activity Monitors' Effect on Health", 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': "TAME Health: Testing Activity Monitors' Effect on Health", 'orgStudyIdInfo': {'id': '15-0014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pedometer', 'description': "All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.", 'interventionNames': ["Behavioral: 5 A's counseling", 'Device: Pedometer']}, {'type': 'EXPERIMENTAL', 'label': 'Electronic Activity Monitor (EAM)', 'description': 'All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.', 'interventionNames': ['Device: EAM', "Behavioral: 5 A's counseling"]}], 'interventions': [{'name': 'EAM', 'type': 'DEVICE', 'otherNames': ['UP24', 'Jawbone', 'Electronic Activity Monitor'], 'description': 'The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.', 'armGroupLabels': ['Electronic Activity Monitor (EAM)']}, {'name': "5 A's counseling", 'type': 'BEHAVIORAL', 'description': 'Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.', 'armGroupLabels': ['Electronic Activity Monitor (EAM)', 'Pedometer']}, {'name': 'Pedometer', 'type': 'DEVICE', 'description': 'The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.', 'armGroupLabels': ['Pedometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77551', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Primary Care Pavilion', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77573', 'city': 'League City', 'state': 'Texas', 'country': 'United States', 'facility': 'Victory Lakes Town Center', 'geoPoint': {'lat': 29.50745, 'lon': -95.09493}}], 'overallOfficials': [{'name': 'Zakkoyya Lewis, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Medical Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}