NCT Number: NCT07404189
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35205, United States
Caroline Cohen, PhD
SUB_INVESTIGATOR
Drew Sayer, PhD
CONTACT
Drew Sayer, PhD
PRINCIPAL_INVESTIGATOR
Katherine Ellison, PhD
SUB_INVESTIGATOR
Lauren Fowler, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive the 12-month FLOW program including nutrition counseling, physician visits, and behavioral health support.
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.
Time frame: Baseline to 12 months
Difference in body weight change between groups
Time frame: Baseline
Percentage of patients who accept Nutu™ when offered
Time frame: Baseline through 12 months
Number of patient log-ins to the Nutu™ app among those accepting Nutu™
Time frame: Baseline to 12 months
Difference in waist circumference change between groups
Time frame: Baseline to 12 months
Difference in body fat percentage change between groups
Time frame: Baseline to 12 months
Difference in change in systolic blood pressure between groups
Time frame: Baseline to 12 months
Difference in change in diastolic blood pressure between groups
Time frame: Baseline to 12 months
Difference in change in LDL Cholesterol between groups
Time frame: Baseline to 12 months
Difference in change in total cholesterol between groups
Time frame: Baseline to 12 months
Difference in change in vertical jump height between groups
Time frame: Baseline to 12 months
Difference in change in hand grip strength between groups
Time frame: Baseline to 12 months
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).
Time frame: Baseline to 12 months
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.
Time frame: Baseline to 12 months
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.
Time frame: Baseline to 12 months
Oxford Happiness Scale. Difference in changes in happiness between groups
Time frame: Baseline to 12 months
Difference in change in hemoglobin A1c between groups
Time frame: Baseline to 12 months
Difference in change in HDL cholesterol between groups
Time frame: Baseline to 12 months
Difference in change in triglycerides between groups
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Evaluation of the Acceptability and Clinical Effectiveness of Augmenting Comprehensive Primary Care-Based Obesity Management With the Nutu™ Digital Health Platform
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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