Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults

{ "Telehealth Weight Loss for Older Adults with Multiple Chronic Conditions", "This study is looking for older adults (ages 65-85) with obesity and multiple chronic conditions to test different ways to help with weight loss through telehealth. You would receive either a personalized diet and exercise plan (prescriptive intervention) or coaching on behavior changes (behavioral intervention). The goal is to find the best initial approach and how to help people who don't lose much weight at first. Researchers will measure your weight change at 8, 26, and 52 weeks to see how well the interventions work. The study aims to improve health and quality of life for older adults.", "design": "This is an interventional study planning to enroll 180 participants. It uses a special design where initial non-responders to treatment may be switched to a different intervention.", "commitments": "You would participate in a 52-week study involving either a prescriptive diet and exercise plan or behavioral health coaching. Your weight will be measured at 8, 26, and 52 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your weight will be measured up to 52 weeks after the start of the study.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06044571

Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults

Recruiting
NAAges 65–85InterventionalTreatment
University of North Carolina, Chapel Hill
~180 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:PrescriptiveBehavioral

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weight from baseline
Measured over 8, 26, 52 weeks
Obesity
Multiple Chronic Conditions
1 sites across 1 states
North Carolina1
  • John Batsis, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

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Eligibility criteria

Inclusion

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

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.
  • Change in weight from baseline8, 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.