NCT06044571Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 12 Sept 2023
- Start date
- 16 Apr 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity
- NCT number
- NCT06044571
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 16 Apr 2024 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- documented diagnosis in the electronic health record of weight loss surgery in the past;
- 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;
- elective surgery in next 12 months;
Other illness
- documented diagnosis in the electronic health record of dementia of any type;
- 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;
- 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);
- 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;
- osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures;
- recent (\<1 mo) COVID-19 infection;
Lab values
- chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR \[glomerular filtration rate\] \<30ml/min);
Other
- 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):
- nursing home or hospital admission in past three months;
- advanced comorbidities based on medical record review;
- weight loss contraindication as noted by the PCP;
- instability of weight loss, which is greater than 5% weight loss in the past 12 weeks;
- 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.
Who the study is looking for
- 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;
Age in the registry: 65 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Center for Aging and Health Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.