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

NCT07404189 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Obesity & Overweight
  • Cardiovascular Risk Factors

Interventions

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.

Sponsors & Collaborators

  • Willow Laboratories, Inc.

    collaborator UNKNOWN

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Drew Sayer, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07404189 on ClinicalTrials.gov