RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests weight-loss programs offered through telehealth, or remote health visits. It is for adults ages 65–85 with obesity and at least two long-term health conditions. The study looks at which programs to start with and what to try next if they do not work well.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65–85 and living independently, not in a nursing home or assisted living.
  • Have obesity, with a body mass index (BMI) of 30 or higher.
  • Speak English.
  • Have at least two long-term health conditions that need ongoing care. Dementia and osteoporosis do not count toward this total.
  • Have approval from your primary care provider.
  • Answer at least 3 questions correctly on the Callahan thinking and memory test, showing you can consent to join.
  • Score at least 12 on the OARS daily-function survey, showing no limits or disability.
  • Score at least 6 out of 10 on a test of readiness to change.

Who can't join

  • Have dementia, past weight-loss surgery, or an untreated mental health condition that would make it hard to take part.
  • Have a life-threatening illness, an illness expected to leave less than 12 months to live, or a hospital or nursing home stay in the past 3 months.
  • Have severe health problems, such as recent heart failure hospital care, a heart attack or stroke in the past 3 months, unstable or severe heart failure, advanced kidney disease, liver failure or liver scarring, or chronic lung disease needing oxygen or steroids. Cancer other than skin cancer needing treatment in the past year also excludes you.
  • Your provider says weight loss is unsafe, you lost more than 5% of your weight in the past 12 weeks, or you use weight-loss drugs before study procedures begin.
  • Have osteoporosis (weak bones), a fracture from a minor injury, or use certain bone medicines. Some bone medicines taken in the past 1–2 years also exclude you.
  • Plan to have elective surgery in the next 12 months, or had COVID-19 less than 1 month ago.
  • Are in another weight-loss study now or took part in one in the past 12 months.
  • Plan to move out of the area in the next 18 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NC