Researchers at the University of Illinois Chicago have been awarded approximately $3.3 million from the National Institute on Aging to study telehealth behavioral interventions among adults 50 and older with excess weight and cardiometabolic risk factors.
The study investigators from UIC, Washington University and the University of Pittsburgh hope to enroll more than 1,000 patients in the multisite clinical trial, which will deliver the behavioral interventions primarily through the interactive patient portal of the electronic health record system used at each university's health system.
This will be one of the largest clinical trials to test behavioral weight loss interventions that are fully remote and integrated into the electronic health record, which is critically important in real-world health care delivery."
UIC's Dr. Jun Ma, the contact principal investigator of the multisite study
The study will use an adaptive treatment model, in which participants are randomized to receive one of two behavioral interventions. One is the base intervention that uses an evidence-based weight loss video program consisting of 12 videos, each 20-25 minutes long. The other intervention augments the video program with problem-solving therapy delivered via videoconferencing by a trained health coach.
In the trial's adaptive treatment model, participants randomized to the base intervention will begin the video program immediately or after a 12-week waiting period. Participants randomized to the augmented intervention will receive problem-solving coaching at the same time as starting the video program or only if they do not achieve at least 3% weight loss after using the video program for six weeks.
"This innovative adaptive treatment design will help us to understand which patients need which interventions at what time," said Ma, the Beth and George Vitoux Professor of Medicine and director of Vitoux Program on Aging and Prevention at the UIC College of Medicine.
"This design will inform clinical care delivery," Ma said. "The study will provide data on which patients who already receive an evidence-based weight loss video program will benefit from adding the health coach-delivered problem-solving therapy, and at what time should this treatment augmentation take place, rather than assuming that this more cost- and time-intensive intervention is needed for everyone at all times. The design of this trial allows us to do more than compare one intervention to another. It helps us understand better how to tailor treatments based on patients' early weight loss. In addition, we will apply machine learning methods and predictive analytics to study outcome prediction for the behavioral interventions."
To enroll participants, the researchers will check the electronic health record for eligibility criteria, like height and weight and diagnoses such as diabetes, hypertension and high cholesterol. Once consented and randomized into the study, participants will receive the weight loss video program through the patient portal of their electronic health record. Those assigned to also receive problem-solving therapy will have telehealth appointments with a health coach via videoconferencing.
Participants' physical activity and weight will be tracked with wearable devices and wireless scales provided by the study, and participants will also be provided with a tablet to ensure access to the patient portal and telehealth coaching.
"Ultimately, we hope to identify effective integrated behavioral interventions to help people reduce their risk of cardiometabolic diseases," Ma said.
Along with Ma, UIC's Dr. Rachel Caskey, associate professor of medicine and pediatrics and head of internal medicine and geriatrics, and Dr. Jonathan Radosta, associate professor of internal medicine and interim chief medical officer at UI Health, UIC's health system, will lead the UIC site for the clinical trial. Elizabeth Venditti, associate professor of psychiatry and epidemiology, will lead the study at the University of Pittsburgh and Thomas Kannampallil, associate professor of anesthesiology, will lead the study at Washington University.