An interventional study of FLOW Program and Nutu™ Offer in Obesity & Overweight and Cardiovascular Risk Factors, sponsored by University of Alabama at Birmingham. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
Behavioral: FLOW Program
Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.
Behavioral: FLOW Program · Behavioral: Nutu™ Offer
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.
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
Waist Circumference
Difference in waist circumference change between groups
Time frame: Baseline to 12 months
Body Fat Percentage
Difference in body fat percentage change between groups
Time frame: Baseline to 12 months
Systolic Blood Pressure
Difference in change in systolic blood pressure between groups
Time frame: Baseline to 12 months
Diastolic Blood Pressure
Difference in change in diastolic blood pressure between groups
Time frame: Baseline to 12 months
LDL Cholesterol
Difference in change in LDL Cholesterol between groups
Time frame: Baseline to 12 months
Total Cholesterol
Difference in change in total cholesterol between groups
Time frame: Baseline to 12 months
Vertical Jump Height
Difference in change in vertical jump height between groups
Time frame: Baseline to 12 months
Grip Strength
Difference in change in hand grip strength between groups
Time frame: Baseline to 12 months
Mindfulness
Short-Form Five Facet Mindfulness Questionnaire. Difference in change in mindfulness between groups. Scores range from 20 to 100 with higher scores indicating greater mindfulness (beneficial outcome).
Time frame: Baseline to 12 months
Resilience
Brief Resilience Scale. Difference in change in resilience between groups. Values range from 1 to 5 with 1.00 - 2.99 indicating low resilience, 3.00 - 4.30 indicating normal/average resilience, and 4.31 - 5.00 indicating high resilience.
Time frame: Baseline to 12 months
Quality of Life
Quality of Life Scale. Difference in change in quality of life between groups. Scores range from 16 to 112 with higher scores indicating a higher, better perceived quality of life.
Time frame: Baseline to 12 months
Happiness
Oxford Happiness Scale. Difference in changes in happiness between groups
Time frame: Baseline to 12 months
Hemoglobin A1c
Difference in change in hemoglobin A1c between groups
Time frame: Baseline to 12 months
HDL Cholesterol
Difference in change in HDL cholesterol between groups
Time frame: Baseline to 12 months
Triglycerides
Difference in change in triglycerides between groups
Time frame: Baseline to 12 months
Plan to share: Yes — A fully de-identified dataset will be shared at the time of publication of the primary results of this trial. The dataset will enable other investigators to replicate the primary study analysis.
Supporting information: Sap, Analytic code
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Alabama at Birmingham