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

The University of Alabama at Birmingham

Status: Begins enrollment this month

Conditions: Obesity & Overweight; Cardiovascular Risk Factors

Treatments: Behavioral: Nutu™ Offer; Behavioral: FLOW Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07404189

IRB-300015959

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Standard FLOW Program

Active Comparator group

Description:

Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.

Treatment:

Behavioral: FLOW Program

FLOW + Nutu™ Offer

Experimental group

Description:

Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined.

Treatment:

Behavioral: FLOW Program

Behavioral: Nutu™ Offer