Optimizing weight loss interventions for older adults

Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial

This study is testing which weight loss program works best for older adults with obesity and health issues, comparing a medical approach to a coaching method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Drugs / interventions: denosumab
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT06044571 on ClinicalTrials.gov

What this trial studies

This study investigates the best initial weight loss intervention for older adults with obesity and multiple chronic conditions. Using a Sequential, Multiple Assignment, Randomized Trial (SMART) design, it will compare a prescriptive, medically-tailored intervention with a behavioral health coaching approach. Participants who do not respond to the initial intervention will be randomized to receive a combination of both strategies or switch to the alternative approach. The goal is to identify effective interventions that improve health outcomes and reduce healthcare costs for this population.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling adults aged 65-85 with obesity and at least two chronic medical conditions.

Not a fit: Patients over 85 years old or those residing in nursing homes or assisted living facilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the health and quality of life for older adults struggling with obesity and multiple chronic conditions.

How similar studies have performed: Other studies have shown promise in using adaptive interventions for weight loss in older adults, suggesting potential success for this approach.

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 (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 this trial is running

Chapel Hill, North Carolina

• UNC Center for Aging and Health — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: John Batsis, MD — University of North Carolina, Chapel Hill
• Study coordinator: Brett R Sheppard, MA

Conditions Obesity; Multiple Chronic Conditions