NCT06044571 · University of North Carolina, Chapel Hill
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Prescriptive
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).
BEHAVIORAL
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.
Primary outcome measures
Change in weight from baseline
Time frame: 8, 26, 52 weeks
Absolute change in weight percentage (%) over time from baseline to 52-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chapel Hill, North Carolina
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations