This study evaluates the acceptability and clinical effectiveness of integrating the Nutu™ digital health platform into a comprehensive primary care-based behavioral obesity treatment program using a Zelen randomized controlled trial design.
This pragmatic randomized clinical trial is conducted within the established FLOW program, a 12-month multidisciplinary behavioral obesity treatment aligned with USPSTF recommendations. Patients initiating FLOW are randomized to standard care or FLOW augmented with an offer of Nutu™, an AI-powered digital health platform providing behavioral support and self-monitoring tools. Outcomes are collected quarterly over 12 months using routinely collected clinical data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
FLOW patients will receive an offer to add the Nutu™ digital health platform to their FLOW treatment plan, which can be accepted or declined. Nutu™ includes features such as AI-powered digital health coaching and food/exercise tracking.
UAB Hospital - Highlands
Birmingham, Alabama, United States
Body Weight
Difference in body weight change between groups
Time frame: Baseline to 12 months
Nutu™ Acceptance
Percentage of patients who accept Nutu™ when offered
Time frame: Baseline
Nutu™ Engagement
Number of patient log-ins to the Nutu™ app among those accepting Nutu™
Time frame: Baseline through 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.