NCT06044571 Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
| NCT ID | NCT06044571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-04-16 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: In 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): * Community-dwelling adult living independently (not a resident of a nursing home or an assisted living); * Aged 65-85 years (unclear benefits of weight loss if \>85 years) * Obesity (body mass index: ≥30 kg/m2); * English-speaking; -≥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/substance abuse, heart failure, hepatitis, Human Immunodeficiency Virus / Acquired Immunodeficiency Disease Syndrome, hyperlipidemia, hypertension, ischemic heart disease, schizophrenia/other psychotic disorders, stroke). We acknowledge that there are no fully defined definitions and hence we will be assessing MCC (or multimorbidity) in different manners; * medical clearance by PCP (Primary Care Provider) * Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent); * OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability) * Readiness to change score of ≥6/10; Exclusion Criteria: Any 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): * documented diagnosis in the electronic health record of dementia of any type; * documented diagnosis in the electronic health record of weight loss surgery in the past; * untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review; * life-threatening illness; * terminal illness (e.g., palliative care, hospice patient) based on medical record review whose life expectancy is \<12 months as determined by a physician; * nursing home or hospital admission in past three months; * advanced comorbidities based on medical record review; * 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); * chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR \[glomerular filtration rate\] \<30ml/min); * non-skin cancer - history of requiring active treatment in the past year; * liver failure or cirrhosis; * chronic obstructive pulmonary disease - on oxygen or requiring steroids; * weight loss contraindication as noted by the PCP; * instability of weight loss, which is greater than 5% weight loss in the past 12 weeks; * anti-obesity medications including orlistat, semaglutide, liraglutide, tirzepetide, naltrexone-bupropion and phentermine prior to initiation of study procedures; * 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; * osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures; * elective surgery in next 12 months; * recent (\<1 mo) COVID-19 infection; * current or past participation (in the past 12 months) in another weight-loss study; * Planning on moving out of the area in the next 18 months.
Contact & Investigator
John Batsis, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06044571 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06044571 currently recruiting?
Yes, NCT06044571 is actively recruiting participants. Contact the research team at brett_sheppard@unc.edu for enrollment information.
Where is the NCT06044571 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06044571 clinical trial?
NCT06044571 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is John Batsis, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 180 participants.
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