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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: f
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‣ In order to be eligible to participate in this study, an individual must meet all of the following criteria based on chart review at the time of screening (within 8 weeks of randomization):

• Community-dwelling adult living independently (not a resident of a nursing home or an assisted living);

• Aged 65-85 years 85 (unclear benefits of weight loss if \>85 years)7-9

• Obesity (body mass index: ≥30 kg/m2);

• English-speaking;

⁃ ≥2 chronic medical conditions that require ongoing care (excluding dementia and osteoporosis as a chronic condition) - these are based on Medicare' MCC (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, Human Immunodeficiency Virus / Acquired Immunodeficiency Disease Syndrome, hyperlipidemia, hypertension, ischemic heart disease, schizophrenia/other psychotic disorders, stroke). We acknowledge that there are no fully defined definitions and hence we will be assessing MCC (or multimorbidity) in different manners;

• medical clearance by PCP (Primary Care Provider)

• Callahan cognitive screen ≥ 3 correct items; items (a score of three or more correct items indicates an ability to consent);

• OARS (Older Americans Resources and Services)survey score of ≥12; (a score of 12 or more indicates no impairments or disability)

• Readiness to change score of ≥6/10;

Locations
United States
North Carolina
UNC Center for Aging and Health
RECRUITING
Chapel Hill
Contact Information
Primary
Amy S Plymale, BS
amynsp@email.unc.edu
919-962-3412
Backup
John A Batsis, MD
John.Batsis@unc.edu
919-843-4096
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 180
Treatments
Active_comparator: 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 Therapy: 40 min).
Active_comparator: Behavioral
Health coaches have a bachelor's degree and take a 6-8-week certification program. 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.~Conceptual model targets include:~1. barrier identification: problem-solving to identify and address barriers to meet goals~2. self-regulation: a focus on self-monitoring and behavior goals with feedback~3. autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.
Experimental: Responders to Prescriptive- Continue Prescriptive
The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.
Experimental: Non-responders to Prescriptive- Switch to Behavioral
Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.
Experimental: Non-responders to Prescriptive- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
Experimental: Responders to Behavioral- Continue Behavioral
The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.
Experimental: Non-responders to Behavioral- Switch to Prescriptive
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants switch first-line treatment strategy to the alternative (prescriptive) as participants may need knowledge to support adherence.
Experimental: Non-responders to Behavioral- Combination of Prescriptive and Behavioral
Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov