Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-01 @ 10:28 AM
Study NCT ID:
NCT04135859
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-10-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.jackson2@nationwidechildrens.org', 'phone': '614-722-3585', 'title': 'Jamie Jackson, Ph.D.', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Randomization to follow-up (approximately 22 weeks)', 'description': 'An adverse event is an unanticipated change in cardiovascular, musculoskeletal, or emotional symptoms that are (1) concerning to the participant and (2) results in seeking medical attention, if cardiovascular or musculoskeletal in nature. Any condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.", 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ankle sprain', 'notes': 'Severity: Moderate Relatedness: Unrelated Expectedness: Unexpected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moderate to Vigorous Physical Activity (MVPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.'}, {'id': 'OG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '15.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer', 'unitOfMeasure': 'Average change in minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants in the Fitbit + Coaching group had missing MVPA data'}, {'type': 'SECONDARY', 'title': 'Sedentary Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.'}, {'id': 'OG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups."}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '88.7', 'groupId': 'OG000'}, {'value': '-49.8', 'spread': '92.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-59.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.', 'unitOfMeasure': 'Average change in minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants in the Fitbit + Coaching group had missing data for sedentary behavior'}, {'type': 'SECONDARY', 'title': 'Exercise Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.'}, {'id': 'OG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups."}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.76', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.', 'unitOfMeasure': 'Average change in mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants from the Fitbit Only group and four participants from the Fitbit + Coaching Sessions group had missing data for VO2peak.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.'}, {'id': 'FG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal due to screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not complete stress test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Did not wear accelerometer and did not complete stress test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.'}, {'id': 'BG001', 'title': 'Fitbit + Coaching Sessions', 'description': "In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).\n\nPhysical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.\n\nPhysical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '22.3', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '22.2', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'MVPA', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Average min/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sedentary Behavior', 'classes': [{'categories': [{'measurements': [{'value': '561.2', 'spread': '100.0', 'groupId': 'BG000'}, {'value': '580.3', 'spread': '118.7', 'groupId': 'BG001'}, {'value': '570.2', 'spread': '107.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Average min/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'VO2Peak', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '31.4', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Three withdrawn participants (2 from Fitbit + Coaching Sessions arm and 1 from Fitbit Only arm) are excluded from the baseline analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-30', 'size': 412527, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-30T15:22', 'hasProtocol': True}, {'date': '2021-07-13', 'size': 174817, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-24T10:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until the condition is revealed (opening an envelope with the condition listed) after the participant consents to Phase 2. Envelopes with the conditions were prepared by the study statistician.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2019-10-21', 'resultsFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-03', 'studyFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate to Vigorous Physical Activity (MVPA)', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer'}], 'secondaryOutcomes': [{'measure': 'Sedentary Behavior', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.'}, {'measure': 'Exercise Tolerance', 'timeFrame': 'From baseline to follow-up (approximately 22 weeks).', 'description': 'Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'physical activity'], 'conditions': ['Cardiovascular Disease Other', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '33112424', 'type': 'DERIVED', 'citation': 'Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.'}]}, 'descriptionModule': {'briefSummary': "This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels.\n\nThe study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment.\n\nParticipants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home)\n2. Are diagnosed with moderate or complex structural congenital heart disease\n3. Live within 120 miles of Nationwide Children's Hospital\n\nExclusion Criteria:\n\n1. Do no speak or write proficiently in English\n2. Have cognitive impairments that would interfere with the completion of study procedures\n3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)\n4. Have been engaged in a formal exercise program within the past 6 months\n5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months\n6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity\n7. Are unable to complete a treadmill-based exercise stress test\n8. Are currently pregnant\n9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)\n10. \\>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer\n11. Do not have access or a device for videoconferencing with the coach"}, 'identificationModule': {'nctId': 'NCT04135859', 'acronym': 'YACHD-PALS', 'briefTitle': 'Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Physical Activity Lifestyle Intervention for Young Adults With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'IRB1600717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fitbit Only', 'description': 'In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).', 'interventionNames': ['Behavioral: Physical Activity Monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Fitbit + Coaching Sessions', 'description': 'In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).', 'interventionNames': ['Behavioral: Physical Activity Lifestyle Intervention', 'Behavioral: Physical Activity Monitoring']}], 'interventions': [{'name': 'Physical Activity Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': "Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.", 'armGroupLabels': ['Fitbit + Coaching Sessions']}, {'name': 'Physical Activity Monitoring', 'type': 'BEHAVIORAL', 'otherNames': ['Fitbit'], 'description': 'A physical activity monitor (Fitbit) will be provided to both groups.', 'armGroupLabels': ['Fitbit + Coaching Sessions', 'Fitbit Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jamie Jackson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jamie Jackson', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}