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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07404189
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Risk Factors
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FLOW Program — BEHAVIORAL
    Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
  • Nutu™ Offer — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard FLOW Program
    Participants receive the standard 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.

Primary Outcome Measure

Body Weight [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UAB Hospital - HighlandsBirminghamAlabama35205
Drew Sayer, PhD
[email protected]
205-354-8950
Drew Sayer, PhD (PRINCIPAL_INVESTIGATOR)
Caroline Cohen, PhD (SUB_INVESTIGATOR)
Katherine Ellison, PhD (SUB_INVESTIGATOR)
Lauren Fowler, PhD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
UAB Hospital - Highlands· Birmingham, AL

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