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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
June 25, 2026
June 1, 2026
1.8 years
February 4, 2026
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Weight
Difference in body weight change between groups
Baseline to 12 months
Secondary Outcomes (2)
Nutu™ Acceptance
Baseline
Nutu™ Engagement
Baseline through 12 months
Other Outcomes (15)
Waist Circumference
Baseline to 12 months
Body Fat Percentage
Baseline to 12 months
Systolic Blood Pressure
Baseline to 12 months
- +12 more other outcomes
Study Arms (2)
Standard FLOW Program
ACTIVE COMPARATORParticipants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
FLOW + Nutu™ Offer
EXPERIMENTALParticipants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All patients enrolled in the FLOW clinical program are eligible.
You may not qualify if:
- Not a patient of the FLOW clinical program at UAB.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Willow Laboratories, Inc.collaborator
Study Sites (1)
UAB Hospital - Highlands
Birmingham, Alabama, 35205, United States
Related Publications (1)
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.
PMID: 34404466BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Drew Sayer, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 11, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ANALYTIC CODE
- Time Frame
- IDP, SAP, and analytic code will be available upon publication of the primary outcomes manuscript for this trial
- Access Criteria
- IDP and supporting information will be made available on PubMed Central along with the primary outcomes manuscript.
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.