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

ConditionsObesity & Overweight Cardiovascular Risk Factors

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients enrolled in the FLOW clinical program are eligible.

Disqualifiers

Not a patient of the FLOW clinical program at UAB.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Standard FLOW ProgramActive comparator 1 intervention

Group B: FLOW + Nutu™ OfferExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Body Weight

Difference in body weight change between groups

Time frame

Baseline to 12 months

Secondary outcomes

Nutu™ Acceptance

Percentage of patients who accept Nutu™ when offered

Time frame

Baseline

Nutu™ Engagement

Number of patient log-ins to the Nutu™ app among those accepting Nutu™

Time frame

Baseline through 12 months

Other outcomes

Waist Circumference

Difference in waist circumference change between groups

Time frame

Baseline to 12 months

Body Fat Percentage

Difference in body fat percentage change between groups

Time frame

Baseline to 12 months

Systolic Blood Pressure

Difference in change in systolic blood pressure between groups

Time frame

Baseline to 12 months

Diastolic Blood Pressure

Difference in change in diastolic blood pressure between groups

Time frame

Baseline to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Willow Laboratories, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: