[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564068":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":65,"studyPopulation":53,"armGroups":66,"interventions":129,"overallOfficials":135,"centralContacts":139,"locations":148,"responsibleParty":169,"collaborators":171,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":53,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":150,"whyStopped":53,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Change in time spent in moderate to vigorous physical activity (minutes\u002Fday)","Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks","pre 12 week intervention and post 12 week intervention",[14,18,22,25,28,31,34,37,41,44,47,50],{"measure":15,"description":16,"timeFrame":17},"Participant feedback","At completion of 12 week intervention, participants will complete an exit survey to collect feedback about the participant's experience. This is not scored.","at the end of the 12 week intervention",{"measure":19,"description":20,"timeFrame":21},"moderate to vigorous physical activity at 6 months","measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention","6 months",{"measure":23,"description":24,"timeFrame":12},"PROMIS Anxiety","Patient self-report of 15 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":26,"description":27,"timeFrame":12},"PROMIS Depressive Symptoms","Patient self-report of 14 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":29,"description":30,"timeFrame":12},"PROMIS Positive Affect","Patient self-report of 39 items from PROMIS positive affect domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":32,"description":33,"timeFrame":12},"PROMIS Anger","Patient self-report of 9 items from PROMIS anger domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":35,"description":36,"timeFrame":12},"PROMIS Psychological Stress Experiences","Patient self-report of 19 items from PROMIS stress domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":38,"description":39,"timeFrame":40},"Change in hand grip strength (age and sex based z-scores)","Change in hand grip strength measured by digital hand dynamometer as a age and sex z-score generated from normative data. Z-score is a statistical measurement that describes a values relationship to the mean of a group of values. Values above the mean have positive standard scores, while those below the mean have negative standard scores.","pre 12-week intervention and post 12-week intervention",{"measure":42,"description":43,"timeFrame":12},"PROMIS Fatigue","Patient self-report of 25 items from PROMIS fatigue domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":45,"description":46,"timeFrame":12},"PROMIS Sleep Disturbance","Patient self-report of 15 items from PROMIS sleep disturbance domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":48,"description":49,"timeFrame":12},"PROMIS Sleep-Related Impairment","Patient self-report of 13 items from PROMIS sleep-related impairment domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",{"measure":51,"description":52,"timeFrame":12},"PROMIS Life Satisfaction","Patient self-report of 42 items from PROMIS life satisfaction domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":53,"timePerspective":53,"maskingInfo":59},"RANDOMIZED","FACTORIAL","A computerized random number generated by the Way to Health platform will assign children to 1 of 16 study conditions for a 12-week intervention period. The study conditions differ with respect to: personalized exercise plan(on vs off), step goals (ramp-up vs fixed), financial incentive (on vs off), and personalized feedback (on vs off). Our design includes one constant: all participants need to self-monitor their physical activity by wearing the FitBit to allow for daily capture of moderate to vigourous physical activity and step counts. The intervention period is therefore designed to test the effectiveness of 4 components, each with two levels, using a factorial design.","TREATMENT",{"masking":60,"maskingDescription":61,"whoMasked":62},"DOUBLE","Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked",[63,64],"CARE_PROVIDER","INVESTIGATOR","For youth with chronic kidney disease (CKD), cardiovascular disease (CVD) is a leading cause of morbidity and early mortality. Physical activity is a well-recognized determinant of health and quality of life, but, youth with CKD are less physically active than their healthy peers. Identification of effective strategies to increase physical activity in youth with CKD is paramount to improving outcomes. The investigators will test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Guided by the Multiphase Optimization Strategy (MOST) framework, an optimization trial will identify intervention components that increase average daily moderate to vigorous physical activity by 15 min\u002Fday, a clinically meaningful increase. The components will be grounded in established behavioral change theories and be delivered via Way to Health, a web-based platform, to overcome barriers at the point of clinical care where time and resources are limited.",[67,73,77,81,85,89,93,97,101,105,109,113,117,120,123,126],{"label":68,"type":69,"description":70,"interventionNames":71},"Fixed step goal only","EXPERIMENTAL","This intervention designed to test if fixed step goals improve physical activity participation.",[72],"Behavioral: Increase Physical Activity",{"label":74,"type":69,"description":75,"interventionNames":76},"Fixed step goal with feedback","This intervention designed to test if fixed step goals and\u002For daily feed back improve physical activity participation.",[72],{"label":78,"type":69,"description":79,"interventionNames":80},"Fixed step goal with financial incentives","This intervention designed to test if fixed step goals and\u002For financial incentives improve physical activity participation.",[72],{"label":82,"type":69,"description":83,"interventionNames":84},"Fixed step goal with financial incentive and feedback","This intervention designed to test if fixed step goals and\u002For financial incentives and\u002For daily feedback improve physical activity participation.",[72],{"label":86,"type":69,"description":87,"interventionNames":88},"Ramped Step goals","This intervention designed to test if ramped step goals improve physical activity participation.",[72],{"label":90,"type":69,"description":91,"interventionNames":92},"Ramped step goals with feedback","This intervention designed to test if ramped step goals and\u002For daily feedback improve physical activity participation.",[72],{"label":94,"type":69,"description":95,"interventionNames":96},"Ramped step goal with financial incentive","This intervention designed to test if ramped step goals and\u002For financial incentive improve physical activity participation.",[72],{"label":98,"type":69,"description":99,"interventionNames":100},"Ramped step goal with financial incentive and feedback","This intervention designed to test if ramped step goals and\u002For financial incentive and\u002For daily feedback improve physical activity participation.",[72],{"label":102,"type":69,"description":103,"interventionNames":104},"Personalized plan with fixed step goal","This intervention designed to test if personalized exercise plan and\u002For fixed step goal improves physical activity participation.",[72],{"label":106,"type":69,"description":107,"interventionNames":108},"Personalized plan with fixed step goal and feedback","This intervention designed to test if personalized exercise plan and\u002For fixed step goal and\u002For daily feedback improves physical activity participation.",[72],{"label":110,"type":69,"description":111,"interventionNames":112},"Personalized plan with fixed step goal and financial incentive","This intervention designed to test if personalized exercise plan and\u002For fixed step goal and\u002For financial incentive improves physical activity participation.",[72],{"label":114,"type":69,"description":115,"interventionNames":116},"Personalized plan with fixed step goal and financial incentive and feedback","This intervention designed to test if personalized exercise plan and\u002For fixed step goal and\u002For financial incentive and\u002For daily feedback improves physical activity participation.",[72],{"label":118,"type":69,"description":103,"interventionNames":119},"Personalized plan with ramped step goal",[72],{"label":121,"type":69,"description":107,"interventionNames":122},"Personalized plan with ramped step goal and feedback",[72],{"label":124,"type":69,"description":111,"interventionNames":125},"Personalized plan with ramped step goal and financial incentive",[72],{"label":127,"type":69,"description":115,"interventionNames":128},"Personalized plan with ramped step goal and financial incentive and feedback",[72],[130],{"type":131,"name":132,"description":133,"armGroupLabels":134,"otherNames":53},"BEHAVIORAL","Increase Physical Activity","Behavioral interventions to improve physical activity",[68,74,82,78,102,106,110,114,118,121,124,127,86,94,98,90],[136],{"name":137,"affiliation":5,"role":138},"Amy Kogon, MD MPH","PRINCIPAL_INVESTIGATOR",[140,145],{"name":141,"role":142,"phone":143,"phoneExt":53,"email":144},"Jillian LoGuidice, BS","CONTACT","267-425-4541","loguidicej@chop.edu",{"name":137,"role":142,"phone":146,"phoneExt":53,"email":147},"215 590 2449","kogona@chop.edu",[149],{"facility":5,"status":150,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":161,"contacts":162},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":157,"coordinates":158},"Point",[159,160],-75.16362,39.95238,{"lat":160,"lon":159},[163,165,168],{"name":164,"role":142,"phone":143,"phoneExt":53,"email":144},"Jill LoGuidice",{"name":166,"role":142,"phone":167,"phoneExt":53,"email":147},"Amy Kogon, MD, MPH","215-590-2449",{"name":166,"role":138,"phone":53,"phoneExt":53,"email":53},{"type":170,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[172],{"name":173,"class":174},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100564068","physical-activity-in-ckd-100564068",false,"NCT06624358","Physical Activity in CKD","Physical Activity in Adolescents With Chronic Kidney Disease","PACKD","Inclusion criteria:\n\nFor adolescent participants:\n\n1. Males or females age 13 - 18 years\n2. Diagnosis of CKD stage II - V not yet on dialysis or with a transplant\n3. English proficiency\n4. Parental\u002Fguardian permission (informed consent), and if applicable, child assent\n\nFor caregiver participants:\n\n1. Parent\u002Flegal guardian of an enrolled adolescent participant\n2. English proficiency\n\nExclusion Criteria:\n\nFor adolescent participants:\n\n1. Pregnant or lactating\n2. Non-ambulatory\n3. Have high physical activity at baseline (\\>45 min\u002Fday of MVPA)\n4. Provide \\\u003C2 days of physical activity data during the run-in period\n5. Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity\n6. Have received a solid organ transplant\n7. Have limited English proficiency\n8. Are on dialysis\n9. In the opinion of the investigator, are unable to comply with the requirements of the study protocol or are unsuitable for the study for any reason\n\nFor caregivers participants:\n\n1\\. Limited English proficiency","ALL","13 Years","18 Years",{"count":187,"type":188},100,"ESTIMATED","INTERVENTIONAL",[191],"NA","The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.",[194],"Chronic Kidney Diseases",[196,197],"chronic kidney disease","CKD","2026-10-06",{"date":200,"type":201},"2026-10-08","ACTUAL",{"date":203,"type":201},"2025-09-30",{"date":205,"type":188},"2028-12",{"name":5,"class":6},1]