[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571842":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Massachusetts Institute of Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opt-in Outreach","ACTIVE_COMPARATOR","Outreach notifies those eligible that they are invited to join the program, as usual practice.",[13],"Behavioral: Opt-in framing",{"label":15,"type":16,"description":17,"interventionNames":18},"Opt-out Outreach","EXPERIMENTAL","Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session.",[19],"Behavioral: Opt-out framing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Opt-out framing","Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Opt-in framing","Eligible participants are invited to enroll",[9],[32],{"name":33,"affiliation":34,"role":35},"Joseph Doyle, PhD","MIT Sloan School of Management","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","6174523761","jjdoyle@mit.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"David Molitor, PhD","2172440504","dmolitor@illinois.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Quest Diagnostics","RECRUITING","Secaucus","New Jersey","07094","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-74.05653,40.78955,{"lat":58,"lon":57},[61,65,68],{"name":62,"role":38,"phone":63,"phoneExt":26,"email":64},"Nicholas Torsiello, PhD MPH","914-450-7162","nicholas.e.torsiello@questdiagnostics.com",{"name":66,"role":38,"phone":63,"phoneExt":26,"email":67},"Karen Liptak-Soriano, BS","karen.m.liptak-soriano@questdiagnostics.com",{"name":69,"role":35,"phone":26,"phoneExt":26,"email":26},"Nicholas Torsiello, PhD",{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[73,75],{"name":74,"class":6},"University of Illinois at Urbana-Champaign",{"name":76,"class":77},"Quest Diagnostics-Nichols Insitute","INDUSTRY","100571842","wellness-program-outreach-and-effectiveness-100571842",false,"NCT06725511","Wellness Program Outreach and Effectiveness","Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Provided informed consent.\n2. Those who are eligible for the Pack Health program:\n\n   * Employees\u002Fspouses\u002Fdomestic partners over the age of 18\n   * Metabolic syndrome defined as results indicating 3 or more of the following risk factors:\n\n     * High waist circumference (\\>35 inches for women and \\>40 inches for men)\n     * High triglycerides (≥150 mg\u002Fdl)\n     * Low HDL cholesterol (\\\u003C50 mg\u002Fdl for women and \\\u003C40 mg\u002Fdl for men)\n     * High Blood Pressure (≥130\u002F85)\n     * High Fasting Glucose (≥100 mg\u002Fdl)\n\nExclusion Criteria:\n\n* 1\\. Anyone under the age of 21. They will not be part of the study and will receive messages as if they were in the control group.\n\n  2\\. Anyone observed in claims data with a historical diagnosis of:\n  * Anorexia nervosa\n  * Bulimia nervosa\n  * Binge-eating disorder\n  * Body dysmorphic disorder\n  * Major depression\n  * Post-traumatic stress disorder (PTSD)\n  * Severe anxiety disorder","ALL","21 Years",{"count":88,"type":89},2000,"ESTIMATED","INTERVENTIONAL",[92],"NA","The investigators will conduct a randomized controlled trial to evaluate the impact of an outreach campaign designed to increase engagement with Pack Health, a Quest Diagnostics wellness program providing individual health coaching for weight management and diabetes prevention. While employee wellness and disease-management programs have the potential to improve wellbeing and reduce healthcare costs, their effectiveness is often undermined by low engagement and selection bias in participant comparisons. This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses\u002Fdomestic partners-into the program, with the option to opt out, can increase engagement and improve health outcomes compared to the standard invitation-based approach.",[95],"Metabolic Syndrome",[95,97],"Workplace wellness","2024-12-04",{"date":100,"type":101},"2024-12-10","ACTUAL",{"date":103,"type":101},"2024-10-02",{"date":105,"type":89},"2026-08-31",{"name":5,"class":6},1]