Clinical trial NCT06044571: Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
Official title: Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults With Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Multiple Chronic Conditions
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-09-21
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A single site two-stage, Phase III clinical trial using a SMART design, will assess the superiority between two first-line strategies (prescriptive, behavioral) on percent weight loss at 52 weeks
Primary purpose: TREATMENT

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 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. If successful, these findings will identify interventions that could markedly improve health and quality of life of these older adults, reduce long-term disability, and lower healthcare costs

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 with obesity and more than 2 chronic conditions, termed multiple chronic conditions (MCC). To this end, the specific aims are to: 1) test the superiority of an initial prescriptive or behavioral intervention using an adaptive strategy for early non-responders; 2) assess the patterns of initial weight loss and compare strategies for non-responders using an adaptive strategy; and 3) examine the cost-effectiveness from a societal perspective for maintaining weight loss of the proposed sequences at 78 weeks (26 weeks post-intervention completion).

Procedures (methods): The investigators will conduct a 52-week, two-stage, Sequential, Multiple Assignment, Randomized Trial (SMART) enrolling 180 older adults with obesity and MCC to compare two weight loss interventions: 1) a prescriptively-focused, medically-tailored, weight loss intervention(prescriptive), or 2) a behaviorally-focused, health coaching intervention (behavioral). Consistent with a SMART design, at 8 weeks, the investigators will randomize early non-responders (weight loss of \< 2.5%) to (a) a combination of prescriptive and behavioral interventions; or (b) switching to either a prescriptive, medically-tailored model (or vice versa).

Aim 1 - Efficacy Test the superiority of an initial prescriptive vs. behavioral intervention on the differences in weight loss (primary outcome) and secondary outcomes, using an adaptive strategy for early non-responders in a 52-week, telehealth-based SMART. At 52-weeks, percent weight loss (primary outcome) will be greater among patients initially randomized to a prescriptive intervention, as will global health and physical function, anthropometry, behavioral treatment targets and risk factors, and clinical indices (secondary outcomes).

Aim 2 - Precision Medicine Assess the patterns of initial weight loss and compare strategies for non-responders to weight loss (combined prescriptive and behavioral, or switching initial treatment strategies \[prescriptive to behavioral, or behavioral to prescriptive\]). The investigators will estimate an adaptive strategy (dynamic treatment regime) to give the right intervention to the right participant. The investigators hypothesize that this dynamic regime will lead to a better outcome, on average, compared to the best non-adaptive (fixed) regime

Aim 3 - Cost-Effectiveness Examine the cost-effectiveness from a societal perspective at 78-weeks (26 weeks post-intervention completion). For the initial, first-line interventions, the investigators will estimate the incremental cost per percent weight change and assess secondary outcomes of the incremental cost for maintaining at least a 5% weight loss, and quality-adjusted life years. The investigators will also model the cost-effectiveness of the precision medicine approach predicted to have the greatest individualized likelihood of weight loss response.

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.

Primary outcomes:
measure: Change in weight from baseline
timeFrame: 8, 16, 26, 52, 78 weeks
Secondary outcomes:
measure: Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in 30-second sit-to-stand from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in grip strength from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in gait speed from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in 6-minute walk from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in waist circumference from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in hip circumference from baseline
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Proportion with greater than or equal to 5% weight loss
timeFrame: 8, 16, 26, 52, 78 weeks
measure: Change in % body fat from baseline
timeFrame: 0, 26, 52 weeks
measure: Change in volume of visceral fat from baseline
timeFrame: 0, 26, 52 weeks
measure: Change in appendicular lean mass from baseline
timeFrame: 0, 26, 52 weeks
measure: Late-life function and disability instrument
timeFrame: 0, 8, 16, 26, 52, 78
measure: Change in Pittsburgh Fatigability questionnaire
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Self-efficacy- exercise
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Self-efficacy- nutrition
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Self-efficacy- technology
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Goal setting- exercise
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Goal setting- nutrition
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in Goal setting- technology
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in social support for diet
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in social support for exercise
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Treatment self-regulation: diet
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Treatment self-regulation: exercise
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in caloric intake
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Physical activity: community healthy activities model program for seniors
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Patient activation measure
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Fitbit use- Wear/non-wear time
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Fitbit use- activity/steps
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Attendance
timeFrame: 78 weeks
measure: Acceptability of Study Intervention
timeFrame: 78 weeks
measure: Percent of participants rating the intervention as acceptable
timeFrame: 78 weeks
measure: Telehealth satisfaction
timeFrame: 52, 78 weeks
measure: Telehealth usability survey
timeFrame: 52 weeks
measure: Change in systolic blood pressure
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in diastolic blood pressure
timeFrame: 0, 8, 16, 26, 52, 78 weeks
measure: Change in low density lipoprotein blood levels
timeFrame: 0, 8, 52 weeks
measure: Change in high density lipoprotein blood levels
timeFrame: 0, 8, 52 weeks
measure: Change in total cholesterol blood levels
timeFrame: 0, 8, 52 weeks
measure: Change in glucose blood levels
timeFrame: 0, 8, 52 weeks
measure: Change in calf circumference from baseline
timeFrame: 8, 16, 26, 52, 78 weeks
measure: Change in arm circumference from baseline
timeFrame: 8, 16, 26, 52, 78 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Aging and Health
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: John Batsis, MD
role: PRINCIPAL_INVESTIGATOR
References: