RECRUITING

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

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Conditions

ObesityMultiple Chronic Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06044571

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.

Ages Eligible for Study:65 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);
  2. * Aged 65-85 years 85 (unclear benefits of weight loss if \>85 years)7-9
  3. * Obesity (body mass index: ≥30 kg/m2);
  4. * English-speaking;
  5. * medical clearance by PCP (Primary Care Provider)
  6. * Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent);
  7. * OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability)
  8. * Readiness to change score of ≥6/10;
  1. * documented diagnosis in the electronic health record of dementia of any type;
  2. * documented diagnosis in the electronic health record of weight loss surgery in the past;
  3. * untreated psychiatric disorder that would impair the ability to participate (bipolar, schizophrenia) based on medical record review;
  4. * life-threatening illness;
  5. * terminal illness (e.g., palliative care, hospice patient) based on medical record review whose life expectancy is \<12 months as determined by a physician;
  6. * nursing home or hospital admission in past three months;
  7. * advanced comorbidities based on medical record review;
  8. * 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);
  9. * chronic renal failure - chronic kidney disease stage IV or V (e.g., GFR \[glomerular filtration rate\] \<30ml/min);
  10. * non-skin cancer - history of requiring active treatment in the past year;
  11. * liver failure or cirrhosis;
  12. * chronic obstructive pulmonary disease - on oxygen or requiring steroids;
  13. * weight loss contraindication as noted by the PCP;
  14. * instability of weight loss, which is greater than 5% weight loss in the past 12 weeks;
  15. * anti-obesity medications including orlistat, semaglutide, liraglutide, tirzepetide, naltrexone-bupropion and phentermine prior to initiation of study procedures;
  16. * 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;
  17. * osteoporosis by medical record (t-score -2.5 and below on hip or spine scan) or history of fragility fractures;
  18. * elective surgery in next 12 months;
  19. * recent (\<1 mo) COVID-19 infection;
  20. * current or past participation (in the past 12 months) in another weight-loss study;
  21. * Planning on moving out of the area in the next 18 months.

Contacts and Locations

Study Contact

Amy S Plymale, BS
CONTACT
919-962-3412
amynsp@email.unc.edu
John A Batsis, MD
CONTACT
919-843-4096
John.Batsis@unc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2027-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Multiple Chronic Conditions