Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01280812
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2010-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008283', 'term': 'Maintenance'}], 'ancestors': [{'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoshimi.fukuoka@ucsf.edu', 'phone': '415-476-8419', 'title': 'Yoshimi Fukuoka, PhD, RN, FAAN', 'organization': 'UC San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.', 'eventGroups': [{'id': 'EG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 11, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance intervention regular program\n\nOver a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to stop using the app (activity diary).', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 10, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 6, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'notes': 'car accident, assault, head injury at work, burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department or Urgent Care Facility Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'Mean total daily steps at baseline', 'categories': [{'measurements': [{'value': '5837', 'spread': '3235', 'groupId': 'OG000'}, {'value': '5063', 'spread': '2526', 'groupId': 'OG001'}, {'value': '5384', 'spread': '2920', 'groupId': 'OG002'}]}]}, {'title': 'Mean total daily steps at 3 months', 'categories': [{'measurements': [{'value': '8709', 'spread': '3910', 'groupId': 'OG000'}, {'value': '8096', 'spread': '3903', 'groupId': 'OG001'}, {'value': '6608', 'spread': '3719', 'groupId': 'OG002'}]}]}, {'title': 'Mean total daily steps at 9 months', 'categories': [{'measurements': [{'value': '7807', 'spread': '4093', 'groupId': 'OG000'}, {'value': '6909', 'spread': '3704', 'groupId': 'OG001'}, {'value': '6265', 'spread': '3524', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1100', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3000', 'groupDescription': 'Intent to treat analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided P values less than .05 were considered statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3, and 9 months', 'description': 'This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.', 'unitOfMeasure': 'Steps/Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis'}, {'type': 'PRIMARY', 'title': 'Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Pedometer', 'description': 'Non-intervention group\n\nControl (pedometer only): This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'Mean Daily MVPA at baseline', 'categories': [{'measurements': [{'value': '43.5', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '24.4', 'groupId': 'OG001'}, {'value': '45.7', 'spread': '33.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean Daily MVPA at 3 months', 'categories': [{'measurements': [{'value': '67.6', 'spread': '34.9', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '33.3', 'groupId': 'OG001'}, {'value': '53.0', 'spread': '38.0', 'groupId': 'OG002'}]}]}, {'title': 'Mean Daily MVPA at 9 months', 'categories': [{'measurements': [{'value': '60.1', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '36.4', 'groupId': 'OG001'}, {'value': '50.8', 'spread': '34.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis'}, {'type': 'SECONDARY', 'title': 'Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'kcal/kg/day at baseline', 'categories': [{'measurements': [{'value': '33.1', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '32.9', 'spread': '1.42', 'groupId': 'OG002'}]}]}, {'title': 'kcal/kg/day at 3 months', 'categories': [{'measurements': [{'value': '34.5', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '33.7', 'spread': '1.78', 'groupId': 'OG002'}]}]}, {'title': 'kcal/kg/day at 9 months', 'categories': [{'measurements': [{'value': '34.3', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '34.1', 'spread': '2.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'An interviewer-administered 7-day physical activity recall (PAR) is used to assess physical activities performed during the week preceding each visit. The PAR is a widely used and well-validated self-report recall instrument that assesses the frequency, duration, and intensity of physical activity. It yields average kcal/kg/day.', 'unitOfMeasure': 'kcal/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Modified Self-Efficacy for Physical Activity Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'Self-efficacy at baseline', 'categories': [{'measurements': [{'value': '19.0', 'spread': '4.79', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '5.09', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '3.95', 'groupId': 'OG002'}]}]}, {'title': 'Self-efficacy at 3 months', 'categories': [{'measurements': [{'value': '18.1', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '5.13', 'groupId': 'OG001'}, {'value': '19.1', 'spread': '5.53', 'groupId': 'OG002'}]}]}, {'title': 'Self-efficacy at 9 months', 'categories': [{'measurements': [{'value': '18.3', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '19.2', 'spread': '5.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Self-Efficacy for Physical Activity will be used to measure how confident the participant is to engage in physical activity in a specific situation. A sample item is, "I am confident I can participate in regular physical activity when I am tired." The measure consists of five items on a scale of 1 to 5, "1" being "not at all confident" and "5" being "very confident." The possible range of scores is from 5 to 25 points. Higher scores indicate higher self-efficacy for physical activity. Reported internal consistency ranges from 0.78 to 0.82. This measure has been widely used in adult women and men. Based on our pilot study, we added one additional question to this survey.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Social Support for Physical Activity (Family)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'Physical activity social support from family at baseline', 'categories': [{'measurements': [{'value': '32.8', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '32.0', 'spread': '9.18', 'groupId': 'OG002'}]}]}, {'title': 'Physical activity social support from family at 3 months', 'categories': [{'measurements': [{'value': '34.8', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '9.94', 'groupId': 'OG002'}]}]}, {'title': 'Physical activity social support from family at 9 months', 'categories': [{'measurements': [{'value': '34.3', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '9.86', 'groupId': 'OG001'}, {'value': '33.4', 'spread': '11.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach\'s alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales. Higher scores indicate greater support.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Social Support for Physical Activity (Friends)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'OG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'OG002', 'title': 'Control', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'classes': [{'title': 'PA social support from friend at baseline', 'categories': [{'measurements': [{'value': '31.8', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '8.21', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '8.91', 'groupId': 'OG002'}]}]}, {'title': 'PA social support from friend at 3 months', 'categories': [{'measurements': [{'value': '34.7', 'spread': '8.36', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '8.48', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '8.35', 'groupId': 'OG002'}]}]}, {'title': 'PA social support from friend at 9 months', 'categories': [{'measurements': [{'value': '35.4', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '33.9', 'spread': '9.17', 'groupId': 'OG001'}, {'value': '31.8', 'spread': '8.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach\'s alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'FG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'FG002', 'title': 'Pedometer', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PA Intervention and Maintenance Plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program\n\nMobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.'}, {'id': 'BG001', 'title': 'PA Intervention and Maintenance Regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program\n\nMobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.'}, {'id': 'BG002', 'title': 'Pedometer', 'description': 'Non-intervention group\n\nPedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '52.4', 'spread': '11.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2010-11-23', 'resultsFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps', 'timeFrame': 'Baseline, 3, and 9 months', 'description': 'This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.'}, {'measure': 'Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.'}], 'secondaryOutcomes': [{'measure': 'Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'An interviewer-administered 7-day physical activity recall (PAR) is used to assess physical activities performed during the week preceding each visit. The PAR is a widely used and well-validated self-report recall instrument that assesses the frequency, duration, and intensity of physical activity. It yields average kcal/kg/day.'}, {'measure': 'Modified Self-Efficacy for Physical Activity Survey', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Self-Efficacy for Physical Activity will be used to measure how confident the participant is to engage in physical activity in a specific situation. A sample item is, "I am confident I can participate in regular physical activity when I am tired." The measure consists of five items on a scale of 1 to 5, "1" being "not at all confident" and "5" being "very confident." The possible range of scores is from 5 to 25 points. Higher scores indicate higher self-efficacy for physical activity. Reported internal consistency ranges from 0.78 to 0.82. This measure has been widely used in adult women and men. Based on our pilot study, we added one additional question to this survey.'}, {'measure': 'Social Support for Physical Activity (Family)', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach\'s alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales. Higher scores indicate greater support.'}, {'measure': 'Social Support for Physical Activity (Friends)', 'timeFrame': 'Baseline, 3 and 9 months', 'description': 'The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach\'s alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mobile phone', 'physical activity', 'women', 'maintenance', 'health promotion', 'prevention'], 'conditions': ['Sedentary Lifestyle', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '22168267', 'type': 'BACKGROUND', 'citation': 'Fukuoka Y, Komatsu J, Suarez L, Vittinghoff E, Haskell W, Noorishad T, Pham K. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol. BMC Public Health. 2011 Dec 14;11:933. doi: 10.1186/1471-2458-11-933.'}, {'pmid': '25872754', 'type': 'BACKGROUND', 'citation': 'Fukuoka Y, Gay C, Haskell W, Arai S, Vittinghoff E. Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial. JMIR Mhealth Uhealth. 2015 Apr 13;3(2):e34. doi: 10.2196/mhealth.3928.'}, {'pmid': '27514368', 'type': 'BACKGROUND', 'citation': 'Fukuoka Y, Haskell W, Vittinghoff E. New insights into discrepancies between self-reported and accelerometer-measured moderate to vigorous physical activity among women - the mPED trial. BMC Public Health. 2016 Aug 11;16(1):761. doi: 10.1186/s12889-016-3348-7.'}, {'pmid': '31859677', 'type': 'DERIVED', 'citation': 'Lindgren T, Hooper J, Fukuoka Y. Perceptions and Experiences of Women Participating in a Digital Technology-Based Physical Activity Intervention (the mPED Trial): Qualitative Study. JMIR Public Health Surveill. 2019 Dec 20;5(4):e13570. doi: 10.2196/13570.'}, {'pmid': '31438926', 'type': 'DERIVED', 'citation': 'Zhou M, Fukuoka Y, Goldberg K, Vittinghoff E, Aswani A. Applying machine learning to predict future adherence to physical activity programs. BMC Med Inform Decis Mak. 2019 Aug 22;19(1):169. doi: 10.1186/s12911-019-0890-0.'}, {'pmid': '31125101', 'type': 'DERIVED', 'citation': 'Fukuoka Y, Haskell W, Lin F, Vittinghoff E. Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women: The mPED Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e194281. doi: 10.1001/jamanetworkopen.2019.4281.'}, {'pmid': '29925491', 'type': 'DERIVED', 'citation': 'Fukuoka Y, Lindgren TG, Mintz YD, Hooper J, Aswani A. Applying Natural Language Processing to Understand Motivational Profiles for Maintaining Physical Activity After a Mobile App and Accelerometer-Based Intervention: The mPED Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10042. doi: 10.2196/10042.'}, {'pmid': '29391341', 'type': 'DERIVED', 'citation': 'Fukuoka Y, Zhou M, Vittinghoff E, Haskell W, Goldberg K, Aswani A. Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis. JMIR Public Health Surveill. 2018 Feb 1;4(1):e10. doi: 10.2196/publichealth.9138.'}, {'pmid': '28418750', 'type': 'DERIVED', 'citation': "Fukuoka Y, Lisha NE, Vittinghoff E. Comparing Asian American Women's Knowledge, Self-Efficacy, and Perceived Risk of Heart Attack to Other Racial and Ethnic Groups: The mPED Trial. J Womens Health (Larchmt). 2017 Sep;26(9):1012-1019. doi: 10.1089/jwh.2016.6156. Epub 2017 Apr 18."}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.', 'detailedDescription': 'Physical inactivity is associated with increased risk of co-morbidity and premature mortality. Given the rapid growth of mobile phone technology and the increasing number of users, the investigators developed an interactive mobile phone-based physical activity intervention for sedentary women. The investigators propose to conduct a randomized, controlled trial to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity over a 3-month period. 192 sedentary women will be randomized in a 2-to-1 ratio to a 3-month mobile phone-based physical activity intervention group or to a control group. To provide insight into how best to maximize the potential for sustained physical activity after completion of the 3-month program, women in the intervention group who complete the physical activity program will be further randomized into a 6-month maintenance intervention-PLUS program (pedometer plus mobile phone diary) or to a 6-month maintenance intervention-REGULAR program (pedometer only). Unlike a conventional maintenance follow-up in which all subjects continue in their respective randomization arms, re-randomizing subjects into either a maintenance intervention-REGULAR group or a maintenance intervention-PLUS group will allow us to examine the "dose-response" of the maintenance methods if the intervention is effective.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary lifestyle at work and/or during leisure time\n* Intend to be physically active\n* Female, age \\>25 to 69\n* Access to a home telephone or a mobile phone\n* Speak and read English\n\nExclusion Criteria:\n\n* Known medical conditions or other physical problems that need special attention in an exercise program\n* Plan a trip abroad during the first 4 months of the study period.\n* Pregnant/Delivered a baby during the last 6 months\n* Known severe hearing or speech problem\n* Body Mass Index (BMI) \\> 43.0 kg/m2\n* Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study\n* History of bariatric surgery or future plans for bariatric surgery in the next 12 months'}, 'identificationModule': {'nctId': 'NCT01280812', 'briefTitle': 'Applying Mobile Persuasive Technologies to Increase Physical Activity in Women', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Applying Mobile Persuasive Technologies to Increase Physical Activity in Women', 'orgStudyIdInfo': {'id': 'P0031274'}, 'secondaryIdInfos': [{'id': '5R01HL104147-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL104147-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA intervention and Maintenance plus', 'description': '3-month physical activity intervention and 6-month maintenance intervention-Plus program', 'interventionNames': ['Behavioral: Mobile phone based physical activity intervention with maintenance plus']}, {'type': 'EXPERIMENTAL', 'label': 'PA intervention and Maintenance regular', 'description': '3-month physical activity intervention and 6-month maintenance - Regular program', 'interventionNames': ['Behavioral: Mobile phone based physical activity intervention with maintenance regular']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pedometer', 'description': 'Non-intervention group', 'interventionNames': ['Behavioral: Control (pedometer only)']}], 'interventions': [{'name': 'Mobile phone based physical activity intervention with maintenance plus', 'type': 'BEHAVIORAL', 'description': 'This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.', 'armGroupLabels': ['PA intervention and Maintenance plus']}, {'name': 'Mobile phone based physical activity intervention with maintenance regular', 'type': 'BEHAVIORAL', 'description': 'This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.', 'armGroupLabels': ['PA intervention and Maintenance regular']}, {'name': 'Control (pedometer only)', 'type': 'BEHAVIORAL', 'description': 'This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.', 'armGroupLabels': ['Pedometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco (Laurel Heights)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Yoshimi Fukuoka, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}