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

Description

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

Conditions

Obesity, Multiple Chronic Conditions

Study Overview

Study Details

Study overview

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

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

UNC Center for Aging and Health, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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;
  • * 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;
  • * 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.

Ages Eligible for Study

65 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

John Batsis, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2027-09-01