[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519517":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":53,"centralContacts":57,"locations":67,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":48,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":48,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":48,"overallStatus":70,"whyStopped":48,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14,19,24,28,32,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Prescriptive","ACTIVE_COMPARATOR","A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals- Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapy: 40 min).",[13],"Other: Prescriptive",{"label":15,"type":10,"description":16,"interventionNames":17},"Behavioral","Health coaches have a bachelor's degree and take a 6-8-week certification program. Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine.\n\nConceptual model targets include:\n\n1. barrier identification: problem-solving to identify and address barriers to meet goals\n2. self-regulation: a focus on self-monitoring and behavior goals with feedback\n3. autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.",[18],"Behavioral: Behavioral",{"label":20,"type":21,"description":22,"interventionNames":23},"Responders to Prescriptive- Continue Prescriptive","EXPERIMENTAL","The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.",[13],{"label":25,"type":21,"description":26,"interventionNames":27},"Non-responders to Prescriptive- Switch to Behavioral","Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.",[18],{"label":29,"type":21,"description":30,"interventionNames":31},"Non-responders to Prescriptive- Combination of Prescriptive and Behavioral","Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.",[13,18],{"label":33,"type":21,"description":34,"interventionNames":35},"Responders to Behavioral- Continue Behavioral","The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.",[18],{"label":37,"type":21,"description":38,"interventionNames":39},"Non-responders to Behavioral- Switch to Prescriptive","Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants switch first-line treatment strategy to the alternative (prescriptive) as participants may need knowledge to support adherence.",[13],{"label":41,"type":21,"description":42,"interventionNames":43},"Non-responders to Behavioral- Combination of Prescriptive and Behavioral","Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.",[13,18],[45,49],{"type":6,"name":9,"description":46,"armGroupLabels":47,"otherNames":48},"Prescriptive A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals, Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs), will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs)will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapist: 40 min).",[41,37,29,9,20],null,{"type":50,"name":15,"description":51,"armGroupLabels":52,"otherNames":48},"BEHAVIORAL","Behavioral Health coaches have a bachelor's degree and take a 6-8-week certification program. Behavioral Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine.",[15,41,29,25,33],[54],{"name":55,"affiliation":5,"role":56},"John Batsis, MD","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":48,"email":62},"Brett R Sheppard, MA","CONTACT","919-423-9264","brett_sheppard@unc.edu",{"name":64,"role":60,"phone":65,"phoneExt":48,"email":66},"John A Batsis, MD","919-843-4096","John.Batsis@unc.edu",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":48},"UNC Center for Aging and Health","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-79.05584,35.9132,{"lat":80,"lon":79},{"type":83,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[85],{"name":86,"class":87},"National Institute on Aging (NIA)","NIH","100519517","optimizing-telehealth-delivery-of-a-weight-loss-intervention-in-older-adults-100519517",false,"NCT06044571","Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults","Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria based on chart review at the time of screening (within 8 weeks of randomization):\n\n* Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);\n* Aged 65-85 years (unclear benefits of weight loss if \\>85 years)\n* Obesity (body mass index: ≥30 kg\u002Fm2);\n* English-speaking;\n\n  -≥2 chronic medical conditions that require ongoing care (excluding dementia and osteoporosis as a chronic condition) - these are based on Medicare' MCC (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug\u002Fsubstance abuse, heart failure, hepatitis, Human Immunodeficiency Virus \u002F Acquired Immunodeficiency Disease Syndrome, hyperlipidemia, hypertension, ischemic heart disease, schizophrenia\u002Fother psychotic disorders, stroke). We acknowledge that there are no fully defined definitions and hence we will be assessing MCC (or multimorbidity) in different manners;\n* medical clearance by PCP (Primary Care Provider)\n* Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent);\n* OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability)\n* Readiness to change score of ≥6\u002F10;\n\nExclusion Criteria:\n\nAny individual who meets one or more of the following criteria will be excluded from participation based on chart review at the time of screening (within 8 weeks of randomization):\n\n* documented diagnosis in the electronic health record of dementia of any type;\n* documented diagnosis in the electronic health record of weight loss surgery in the past;\n* untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review;\n* life-threatening illness;\n* terminal illness (e.g., palliative care, hospice patient) based on medical record review whose life expectancy is \\\u003C12 months as determined by a physician;\n* nursing home or hospital admission in past three months;\n* advanced comorbidities based on medical record review;\n* heart - recent hospital admission for heart failure, myocardial infarction, stroke in past 3 months, unstable disease (new york class III or IV congestive heart failure);\n* chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR \\[glomerular filtration rate\\] \\\u003C30ml\u002Fmin);\n* non-skin cancer - history of requiring active treatment in the past year;\n* liver failure or cirrhosis;\n* chronic obstructive pulmonary disease - on oxygen or requiring steroids;\n* weight loss contraindication as noted by the PCP;\n* instability of weight loss, which is greater than 5% weight loss in the past 12 weeks;\n* anti-obesity medications including orlistat, semaglutide, liraglutide, tirzepetide, naltrexone-bupropion and phentermine prior to initiation of study procedures;\n* current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, Parathyroid Hormone Analogues (PTH-analogues \\[e.g., teriparatide, abaloparatide\\], sclerostin) inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years;\n* osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures;\n* elective surgery in next 12 months;\n* recent (\\\u003C1 mo) COVID-19 infection;\n* current or past participation (in the past 12 months) in another weight-loss study;\n* Planning on moving out of the area in the next 18 months.","ALL","65 Years","85 Years",{"count":99,"type":100},180,"ESTIMATED","INTERVENTIONAL",[103],"NA","This study seeks to answer the fundamental questions of which initial, first-line weight loss intervention should be offered to older adults with obesity and multiple chronic conditions and how to address the high non-response rates observed with most conventional strategies. A sequential, multiple assignment, randomized trial (SMART) design will permit the evaluation of treatment combinations that maximize weight loss and will provide data on constructing a future tailored, adaptive intervention. If successful, these findings will identify interventions that could markedly improve health and quality of life of these older adults, reduce long-term disability, and lower healthcare costs",[106,107],"Obesity","Multiple Chronic Conditions","2026-02-04",{"date":110,"type":111},"2026-02-06","ACTUAL",{"date":113,"type":111},"2024-04-16",{"date":115,"type":100},"2027-09-01",{"name":5,"class":6},1]