Status:
RECRUITING
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Obesity
Multiple Chronic Conditions
Eligibility:
All Genders
65-85 years
Phase:
NA
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 add...
Detailed Description
Purpose: Consistent with the research priorities of the National Institute on Aging, this research protocol will investigate the optimal intervention sequence to achieve weight loss in older adults wi...
Eligibility Criteria
Inclusion
- 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 85 (unclear benefits of weight loss if \>85 years)7-9
- 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
- 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.
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06044571
Start Date
April 16 2024
End Date
September 1 2027
Last Update
December 17 2024
Active Locations (1)
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1
UNC Center for Aging and Health
Chapel Hill, North Carolina, United States, 27599