Augmenting Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform

Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Risk Factors; Obesity & Overweight
• Intervention / Treatment: Behavioral: FLOW Program; Behavioral: Nutu™ Offer

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Drew Sayer, PhD; Phone Number: 205-354-8950; Email: dsayer@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Hospital - Highlands
      • Principal Investigator: Drew Sayer, PhD
      • Contact: Drew Sayer, PhD; Phone Number: 205-354-8950; Email: dsayer@uabmc.edu
      • Sub-Investigator: Caroline Cohen, PhD
      • Sub-Investigator: Katherine Ellison, PhD
      • Sub-Investigator: Lauren Fowler, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients enrolled in the FLOW clinical program are eligible.

Exclusion Criteria:

• Not a patient of the FLOW clinical program at UAB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard FLOW Program; Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.	Behavioral: FLOW Program; Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
Experimental: FLOW + Nutu™ Offer; Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.	Behavioral: FLOW Program; Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.; Behavioral: Nutu™ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Difference in body weight change between groups	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutu™ Acceptance	Percentage of patients who accept Nutu™ when offered	Baseline
Nutu™ Engagement	Number of patient log-ins to the Nutu™ app among those accepting Nutu™	Baseline through 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	Difference in waist circumference change between groups	Baseline to 12 months
Body Fat Percentage	Difference in body fat percentage change between groups	Baseline to 12 months
LDL Cholesterol	Difference in change in LDL Cholesterol between groups	Baseline to 12 months
Total Cholesterol	Difference in change in total cholesterol between groups	Baseline to 12 months
Vertical Jump Height	Difference in change in vertical jump height between groups	Baseline to 12 months
Grip Strength	Difference in change in hand grip strength between groups	Baseline to 12 months
Happiness	Oxford Happiness Scale. Difference in changes in happiness between groups	Baseline to 12 months
Hemoglobin A1c	Difference in change in hemoglobin A1c between groups	Baseline to 12 months
HDL Cholesterol	Difference in change in HDL cholesterol between groups	Baseline to 12 months
Triglycerides	Difference in change in triglycerides between groups	Baseline to 12 months
Systolic Blood Pressure	Difference in change in systolic blood pressure between groups	Baseline to 12 months
Diastolic Blood Pressure	Difference in change in diastolic blood pressure between groups	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).	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.	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.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Willow Laboratories, Inc.
• Investigators: Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Simon GE, Shortreed SM, DeBar LL. Zelen design clinical trials: why, when, and how. Trials. 2021 Aug 17;22(1):541. doi: 10.1186/s13063-021-05517-w.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: weight management; digital health coaching; intensive behavioral therapy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: IRB-300015959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: IDP, SAP, and analytic code will be available upon publication of the primary outcomes manuscript for this trial
• IPD Sharing Access Criteria: IDP and supporting information will be made available on PubMed Central along with the primary outcomes manuscript.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No