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

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best ways to help older adults with obesity and multiple health conditions lose weight through telehealth, which means the program will be delivered online or over the phone. Researchers want to find out which initial weight loss methods work best for this age group and how to improve participation since many people do not respond to traditional weight loss programs. The goal is to develop a personalized approach that can significantly enhance the health and quality of life for older adults, while also reducing healthcare costs and long-term disabilities.

To be eligible for the study, participants should be between 65 and 85 years old, live independently (not in a nursing home), have a body mass index (BMI) of 30 or higher, and speak English. They must also have at least two ongoing health issues, like diabetes or heart disease, but should not have certain conditions such as dementia or severe kidney disease. If chosen to participate, individuals can expect to engage in a weight loss program tailored to their needs, along with support and guidance throughout the process. It's important to note that this study is currently recruiting participants, so if you or someone you know fits the criteria and is interested, it could be a great opportunity to make a positive change in health.

Gender

ALL

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 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 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.