[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556531":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":48,"locations":56,"responsibleParty":71,"collaborators":73,"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":33,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":59,"whyStopped":33,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Arizona State University","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"SMS\u002FText (CAMPI)","EXPERIMENTAL","Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.",[13,14],"Behavioral: SMS\u002FText (CAMPI)","Behavioral: Family Check-Up 4 Health (FCU4Health)",{"label":16,"type":10,"description":17,"interventionNames":18},"Fidelity Monitoring (Lyssn and COACH)","Standard Training Activities\n\n1. asynchronous training in the program via an e-learning program\n2. synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities\n3. use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs\n4. group supervision (typically for a period of a year provided by a certified Trainer and then taken over by the organization in a train-the-trainer type model) Enhanced Supervision Activities\n5. use of the Lyssn system to provide individualized feedback to BHCs\n\nAll BHCs will receive the standard training activities (a-b). For the experimental condition, half of the BHCs will be randomly assigned to full fidelity support strategy, which will include the standard and enhanced supervision activities (c-e).",[19,14],"Behavioral: Fidelity Monitoring (Lyssn and COACH)",{"label":21,"type":10,"description":22,"interventionNames":23},"SMS\u002FText (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)","Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.\n\nReceives fidelity monitoring via COACH and Lyssn.",[13,19,14],{"label":25,"type":10,"description":26,"interventionNames":27},"No CAMPI or Fidelity Monitoring","Receives neither SMS\u002FText (CAMPI) or Fidelity Monitoring (Lyssn and COACH).",[14],[29,34,37],{"type":30,"name":9,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.",[9,21],null,{"type":30,"name":16,"description":35,"armGroupLabels":36,"otherNames":33},"Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists.\n\nThe COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is:\n\nConceptually accurate and adherent to the intervention model Observant and responsive to the family's needs Active in structuring the session Careful when teaching and providing feedback Helpful in building hope and motivation",[16,21],{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":33},"Family Check-Up 4 Health (FCU4Health)","An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.",[16,25,9,21],[42,45],{"name":43,"affiliation":5,"role":44},"Cady Berkel, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":47,"role":44},"Justin D Smith, Ph.D.","University of Utah",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Michele M Porter, Ph.D.","CONTACT","4802037550","michele.porter@asu.edu",{"name":43,"role":51,"phone":33,"phoneExt":33,"email":55},"cady.berkel@asu.edu",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":33},"Denova Integrated Healthcare","RECRUITING","Phoenix","Arizona","85012","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-112.07404,33.44838,{"lat":69,"lon":68},{"type":72,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[74,76,78,79],{"name":75,"class":6},"Northwestern University",{"name":77,"class":6},"University of Oregon",{"name":47,"class":6},{"name":80,"class":81},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100556531","primary-care-evidence-based-approach-for-improving-lifelong-health-100556531",false,"NCT06526312","Primary Care Evidence-based Approach for Improving Lifelong Health","Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial","PREVAIL","Inclusion Criteria:\n\n* BMI at or above 85 percentile for age and gender.\n\nExclusion Criteria:\n\n* N\u002FA","ALL","2 Years","99 Years",{"count":94,"type":95},840,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing cardiovascular disease risk in children. Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records, the study aims to enhance intervention fidelity and engagement. Results will inform scalable approaches to promote child and family health behaviors, improve parenting skills, and potentially reduce child BMI, contributing to significant public health impacts in addressing cardiovascular health disparities.",[101],"Clinical Trial",[103,104,105,106],"implementation","cost-effectiveness","health behaviors","BMI","2025-08-01",{"date":109,"type":110},"2025-08-06","ACTUAL",{"date":112,"type":110},"2025-06-09",{"date":114,"type":95},"2028-07",{"name":5,"class":6},1]