About this trial
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
Eligibility criteria
Qualifiers
Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);
Aged 65-85 years (unclear benefits of weight loss if >85 years)
Obesity (body mass index: ≥30 kg/m2);
English-speaking;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Prescriptive
- Behavioral
Treatment groups
8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Aging (NIA)
Collaborator