Actively Recruiting
Optimizing Telehealth Delivery of Weight Loss Interventions in Older Adults With Multiple Chronic Conditions Using a Sequential, Multiple Assignment, Randomized Trial
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-06
180
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating which first-line weight loss intervention works best for older adults with obesity and multiple chronic health conditions. The study focuses on understanding how to manage high rates of non-response to usual weight loss strategies. This trial uses a special design to test combinations of treatments to find the most effective approach for improving health, quality of life, and reducing disability and healthcare costs in this population. Participants will receive one of two telehealth-delivered weight loss programs over 52 weeks: a prescriptive approach with tailored diet and exercise plans guided by dietitians and physical therapists, or a behavioral approach led by certified health coaches focusing on motivation and problem-solving. After 8 weeks, those who lose less than 2.5% of their body weight may switch or combine treatments to improve results. Successful participants continue their assigned intervention. During the study, participants will attend live group and individual sessions via telemedicine. Researchers will monitor weight changes at multiple points and assess physical function, body composition, activity levels, and health-related quality of life using questionnaires and physical tests. The study also evaluates treatment acceptability, telehealth satisfaction, and cost-effectiveness. Participants engage in assessments throughout the year-long study to support personalized weight loss strategies.
CONDITIONS
Brief Title
Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Community-dwelling adults living independently (not in nursing homes or assisted living)
- Aged 65 to 85 years
- Obesity with body mass index of 30 kg/m2 or higher
- English-speaking
- Have at least 2 chronic medical conditions requiring ongoing care (excluding dementia and osteoporosis)
- Medical clearance by primary care provider
- Ability to consent as indicated by Callahan cognitive screen score of 3 or higher
- No impairments or disability as indicated by OARS survey score of 12 or higher
- Readiness to change score of 6 or higher out of 10
You will not qualify if you...
- Diagnosis of dementia of any type
- Prior weight loss surgery
- Untreated psychiatric disorders impairing participation (e.g., bipolar, schizophrenia)
- Life-threatening or terminal illness with less than 12 months life expectancy
- Nursing home or hospital admission in past 3 months
- Advanced comorbidities or unstable heart disease
- Chronic kidney disease stage IV or V (GFR less than 30 ml/min)
- Active non-skin cancer treatment within past year
- Liver failure or cirrhosis
- COPD requiring oxygen or steroids
- Contraindications to weight loss as noted by primary care provider
- Unstable weight loss over past 12 weeks (more than 5%)
- Use of anti-obesity medications before study
- Use of bone-acting medications in past 1-2 years
- Osteoporosis or history of fragility fractures
- Planned elective surgery 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (telehealth)
Duration - 52 weeks
Participants receive either a prescriptive, medically-tailored weight loss intervention or a behavioral health coaching intervention delivered via telehealth. After 8 weeks, early non-responders are re-randomized to either continue, switch, or combine these interventions to optimize weight loss.
Regular telehealth sessions including group and individual coaching; initial sessions last 60 minutes
Trial Site Locations
Total: 1 location
1
UNC Center for Aging and Health
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
B
Brett R Sheppard, MA
J
John A Batsis, MD
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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