Cardiovascular Risk Factors, Obesity & Overweight
Conditions
Keywords
intensive behavioral therapy, digital health coaching, weight management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFLOW Program
Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
BEHAVIORALNutu™ Offer
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.
Sponsors
University of Alabama at Birmingham
Willow Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Zelen clinical trial design. FLOW patients offered to augment their treatment plan with the Nutu app can accept or decline this addition to their plan.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients enrolled in the FLOW clinical program are eligible.
Exclusion criteria
* Not a patient of the FLOW clinical program at UAB.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Baseline to 12 months | Difference in body weight change between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutu™ Acceptance | Baseline | Percentage of patients who accept Nutu™ when offered |
| Nutu™ Engagement | Baseline through 12 months | Number of patient log-ins to the Nutu™ app among those accepting Nutu™ |
Countries
United States
Contacts
CONTACTDrew Sayer, PhD
PRINCIPAL_INVESTIGATORDrew Sayer, PhD
University of Alabama at Birmingham
Outcome results
None listed