Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity of North Carolina, Chapel Hill
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Prescriptive
Other interventionPrescriptive 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
BehavioralBehavioral 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.
Treatment groups
180 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: PrescriptiveActive comparator 1 intervention
Group B: BehavioralActive comparator 1 intervention
Group C: Responders to Prescriptive- Continue PrescriptiveExperimental treatment 1 intervention
Group D: Non-responders to Prescriptive- Switch to BehavioralExperimental treatment 1 intervention
Group E: Non-responders to Prescriptive- Combination of Prescriptive and BehavioralExperimental treatment 2 interventions
Group F: Responders to Behavioral- Continue BehavioralExperimental treatment 1 intervention
Group G: Non-responders to Behavioral- Switch to PrescriptiveExperimental treatment 1 intervention
Group H: Non-responders to Behavioral- Combination of Prescriptive and BehavioralExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in weight from baseline
Absolute change in weight percentage (%) over time from baseline to 52-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.
Time frame
8, 26, 52 weeksSecondary outcomes
1
Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
PROMIS (Patient Reported Outcomes Measurement Information System) gauges physical, mental, and social aspects of health (5-point scale). A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Time frame
0, 8, 16, 26, 52 weeks2
Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
Self-reported physical function (5-point scale) measure that is a responsive measure evaluating mobility and activities of daily living; A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Time frame
0, 8, 16, 26, 52 weeks3
Change in 30-second sit-to-stand from baseline
This is a construct of physical function that predicts falls and disability and is sensitive to change. The 30-second sit-to-stand test is administered using a folding chair without arms and involves recording the number of stands from a seated position a person can complete in 30 seconds. Change in 30-s sit-to-stand in repetitions over time will be reported from baseline to 52-weeks. An improvement in repetitions will represent an improvement of physical function. The continuous value correlates with quadriceps Minimal Clinically Important Difference (2.0 repetitions)
Time frame
0, 8, 26, 52 weeks4
Change in grip strength from baseline
An objective measure that relates to upper and lower extremity strength, and predicts mobility disability. Using a Jamar dynamometer, change in participant's maximal grip strength measurement in kilograms from baseline. Absolute change in grip strength in kilograms over time will be reported from baseline to 52-weeks. An increase in kilograms represented on the device will represent an improvement of physical function. No cutoffs will be used for this - the research team will be use the continuous value.
Time frame
0, 8, 26, 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov