Augmenting Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FLOW Program, Nutu™ Offer.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Cardiovascular Risk Factors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
Overview
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.
Detailed 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.
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.
Primary outcome measures
- Body Weight [Time frame: Baseline to 12 months]
Secondary outcome measures (2)
- Nutu™ Acceptance [Time frame: Baseline]
- Nutu™ Engagement [Time frame: Baseline through 12 months]
Eligibility criteria
Inclusion criteria
- All patients enrolled in the FLOW clinical program are eligible.
Exclusion criteria
- Not a patient of the FLOW clinical program at UAB.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UAB Hospital - Highlands — Birmingham
Publications
- 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 34404466
Identifiers
NCT: NCT07404189 · IRB-300015959