Actively Recruiting

Phase Not Applicable
Age: 65Years - 85Years
All Genders
NCT06044571

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-06

180

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Community-dwelling adult living independently (not in nursing home or assisted living)
  • Aged 65 to 85 years
  • Obesity with body mass index of 30 kg/m2 or higher
  • English-speaking
  • Have two or more chronic medical conditions requiring ongoing care (excluding dementia and osteoporosis)
  • Medical clearance from Primary Care Provider
  • Callahan cognitive screen score of 3 or more correct items
  • Older Americans Resources and Services survey score of 12 or higher
  • Readiness to change score of 6 or higher out of 10
Not Eligible

You will not qualify if you...

  • Diagnosis of any type of dementia
  • Previous weight loss surgery
  • Untreated psychiatric disorder impairing participation (e.g., bipolar disorder, schizophrenia)
  • Life-threatening illness
  • Terminal illness with life expectancy less than 12 months
  • Nursing home or hospital admission in past 3 months
  • Advanced comorbidities
  • Recent heart failure hospitalization or unstable heart disease
  • Chronic kidney disease stage IV or V (GFR less than 30 ml/min)
  • Active non-skin cancer treatment in past year
  • Liver failure or cirrhosis
  • COPD requiring oxygen or steroids
  • Weight loss contraindication by Primary Care Provider
  • Unstable weight loss greater than 5% in past 12 weeks
  • Use of anti-obesity medications before study
  • Use of certain bone-acting medications in past 1-2 years
  • Osteoporosis or history of fragility fractures
  • Elective surgery planned in next 12 months
  • Recent COVID-19 infection within past month
  • Participation in another weight loss study in past 12 months
  • Planning to move away within next 18 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UNC Center for Aging and Health

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

B

Brett R Sheppard, MA

CONTACT

J

John A Batsis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

8

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