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

Summary

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

Interventions

OTHER

Prescriptive

Prescriptive A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals, Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs), will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs)will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapist: 40 min).

BEHAVIORAL

Behavioral

Behavioral Health coaches have a bachelor's degree and take a 6-8-week certification program. Behavioral Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-16

Primary Completion

2027-09-01

Completion

2027-09-01

Countries

• United States

Study Locations