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| Name | Class |
|---|---|
| Willow Laboratories, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard FLOW Program | Active Comparator | Participants receive the standard 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOW Program | Behavioral | Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Difference in body weight change between groups | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nutu™ Acceptance | Percentage of patients who accept Nutu™ when offered | Baseline |
| Nutu™ Engagement | Number of patient log-ins to the Nutu™ app among those accepting Nutu™ |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Difference in waist circumference change between groups | Baseline to 12 months |
| Body Fat Percentage | Difference in body fat percentage change between groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Drew Sayer, PhD | Contact | 205-354-8950 | dsayer@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Drew Sayer, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital - Highlands | Birmingham | Alabama | 35205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34404466 | Background | 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. |
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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.
IDP, SAP, and analytic code will be available upon publication of the primary outcomes manuscript for this trial
IDP and supporting information will be made available on PubMed Central along with the primary outcomes manuscript.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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| 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. |
|
| Baseline through 12 months |
| Baseline to 12 months |
| Systolic Blood Pressure | Difference in change in systolic blood pressure between groups | Baseline to 12 months |
| Diastolic Blood Pressure | Difference in change in diastolic blood pressure between groups | Baseline to 12 months |
| LDL Cholesterol | Difference in change in LDL Cholesterol between groups | Baseline to 12 months |
| Total Cholesterol | Difference in change in total cholesterol between groups | Baseline to 12 months |
| Vertical Jump Height | Difference in change in vertical jump height between groups | Baseline to 12 months |
| Grip Strength | Difference in change in hand grip strength between groups | Baseline to 12 months |
| Mindfulness | Short-Form Five Facet Mindfulness Questionnaire. Difference in change in mindfulness between groups. Scores range from 20 to 100 with higher scores indicating greater mindfulness (beneficial outcome). | Baseline to 12 months |
| Resilience | Brief Resilience Scale. Difference in change in resilience between groups. Values range from 1 to 5 with 1.00 - 2.99 indicating low resilience, 3.00 - 4.30 indicating normal/average resilience, and 4.31 - 5.00 indicating high resilience. | Baseline to 12 months |
| Quality of Life | Quality of Life Scale. Difference in change in quality of life between groups. Scores range from 16 to 112 with higher scores indicating a higher, better perceived quality of life. | Baseline to 12 months |
| Happiness | Oxford Happiness Scale. Difference in changes in happiness between groups | Baseline to 12 months |
| Hemoglobin A1c | Difference in change in hemoglobin A1c between groups | Baseline to 12 months |
| HDL Cholesterol | Difference in change in HDL cholesterol between groups | Baseline to 12 months |
| Triglycerides | Difference in change in triglycerides between groups | Baseline to 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |