[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516323":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":74,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":34,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":60,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Living Well with Congenital Heart Disease (LIV-CHD) Intervention","ACTIVE_COMPARATOR","In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.",[13,14,15],"Behavioral: Physical Activity Monitoring","Behavioral: Tailored Exercise Prescription","Behavioral: Healthy Lifestyle Education",{"label":17,"type":18,"description":19,"interventionNames":20},"Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention","EXPERIMENTAL","In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.",[13,14,15,21],"Behavioral: Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior",[23,30,35,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Physical Activity Monitoring","A physical activity monitor (Fitbit) will be provided to participants in both arms.",[17,9],[29],"Fitbit",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Tailored Exercise Prescription","Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.",[17,9],null,{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Healthy Lifestyle Education","Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.",[17,9],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior","Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.",[17],[44],"CHD-PAL",[46],{"name":47,"affiliation":5,"role":48},"Jamie L Jackson, PhD","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":34,"email":53},"CONTACT","6147223585","jamie.jackson2@nationwidechildrens.org",{"name":55,"role":51,"phone":56,"phoneExt":34,"email":57},"Ruri Famelia, PhD","6143553499","ruri.famelia@nationwidechildrens.org",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Columbus","Ohio","43205","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-82.99879,39.96118,{"lat":70,"lon":69},[73],{"name":47,"role":51,"phone":52,"phoneExt":34,"email":53},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Jamie Jackson","Principal Investigator",[79],{"name":80,"class":81},"National Institute of Nursing Research (NINR)","NIH","100516323","congenital-heart-disease-physical-activity-lifestyle-study-v2-100516323",false,"NCT06003023","Congenital Heart Disease Physical Activity Lifestyle Study V.2","Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention","CHD-PALS V2","Inclusion Criteria:\n\n* Between the ages of 15-25 years\n* Diagnosed with moderate or complex structural CHD\n* Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU)\n\nExclusion Criteria:\n\n* Unable to speak and read proficiently in English\n* Have a diagnosis of a genetic syndrome that impacts multiple organ systems\n* Have cognitive impairments that would interfere with completing study measures\n* Have been engaged in a formal exercise program within the past 6 months,\n* Have participated in the intervention arm of the previous CHD-PAL Study\n* Have undergone open-heart surgery or had a valve replacement in the last 3 months\n* Are unable to complete an exercise stress test using a treadmill\n* Are pregnant\n* Are prohibited to engage in at least moderate levels of physical activity by their cardiologist\n* Engage in \\>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer\n* Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)","ALL","15 Years","25 Years",{"count":94,"type":95},144,"ESTIMATED","INTERVENTIONAL",[98],"NA","The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.",[101,102],"Heart Defects, Congenital","Cardiovascular Disease Other",[104,105,106,107],"congenital heart disease","physical activity","adolescents","young adults","2026-05-28",{"date":110,"type":111},"2026-06-01","ACTUAL",{"date":113,"type":111},"2023-07-18",{"date":115,"type":95},"2027-07-30",{"name":76,"class":6},1]