Obesity & OverweightNCT07404189
Augmenting Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
A study testing FLOW Program and Nutu™ Offer in people with Obesity & Overweight and Cardiovascular Risk Factors, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Cardiovascular Risk Factors
- What is being tested?
- FLOW Program and Nutu™ Offer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients enrolled in the FLOW clinical program are eligible.
Who cannot join
- Not a patient of the FLOW clinical program at UAB.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
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.
Read the 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.
- Conditions
- Obesity & Overweight, Cardiovascular Risk Factors
- Being tested
- FLOW Program, Nutu™ Offer
- Keywords
- intensive behavioral therapy, digital health coaching, weight management
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOW ProgramBehavioural
Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
Nutu™ OfferBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard FLOW Program | Active comparator | Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support. Receives: Behavioral: FLOW Program |
| FLOW + Nutu™ Offer | Experimental | Participants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined. Receives: Behavioral: FLOW Program; Behavioral: Nutu™ Offer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Difference in body weight change between groups
Measured: Baseline to 12 months
Secondary outcomes (2)
Nutu™ Acceptance
Percentage of patients who accept Nutu™ when offered
Measured: Baseline
Nutu™ Engagement
Number of patient log-ins to the Nutu™ app among those accepting Nutu™
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start24 Aug 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Zelen clinical trial design. FLOW patients offered to augment their treatment plan with the Nutu app can accept or decline this addition to their plan.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Willow Laboratories, Inc.
- Responsible party
- Principal investigator, Drew Sayer, University of Alabama at Birmingham
- Investigators
- Drew Sayer, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404189
- Sponsor's protocol ID
- IRB-300015959
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A fully de-identified dataset will be shared at the time of publication of the primary results of this trial. The dataset will enable other investigators to replicate the primary study analysis.
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.
PubMed 34404466
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
- ClinicalTrials.gov ID
- NCT07404189
- Acronym / sponsor ID
- IRB-300015959
- Conditions
- Obesity & Overweight, Cardiovascular Risk Factors
- Keywords
- intensive behavioral therapy, digital health coaching, weight management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Willow Laboratories, Inc.
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Zelen clinical trial design. FLOW patients offered to augment their treatment plan with the Nutu app can accept or decline this addition to their plan.
| Arm | Type | Receives |
|---|---|---|
| Standard FLOW Program | Active comparator | Behavioral: FLOW ProgramParticipants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support. |
| FLOW + Nutu™ Offer | Experimental | Behavioral: FLOW Program, Behavioral: Nutu™ OfferParticipants receive standard FLOW care and are offered access to the Nutu™ digital health platform, which may be accepted or declined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients enrolled in the FLOW clinical program are eligible.
Key exclusion criteria (1 listed)
- Not a patient of the FLOW clinical program at UAB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOW ProgramParticipants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support. | Behavioural | FLOW + Nutu™ Offer, Standard FLOW Program |
| Nutu™ OfferFLOW 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. | Behavioural | FLOW + Nutu™ Offer |
Primary outcome
Body Weight
Time frame: Baseline to 12 months
Difference in body weight change between groups
2 secondary outcomes
Nutu™ Acceptance
Time frame: Baseline
Nutu™ Engagement
Time frame: Baseline through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 34404466Simon 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.
- Individual participant dataSharing planned: Yes. A fully de-identified dataset will be shared at the time of publication of the primary results of this trial. The dataset will enable other investigators to replicate the primary study analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Drew Sayer, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLOW Program and Nutu™ Offer in people with Obesity & Overweight and Cardiovascular Risk Factors, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07404189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.