- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514312
Sustainable and AI-Enabled Adolescents and Youth-Centred Interventions to Upgrade Food Choices and Promote Healthy, Sustainable Diets (STAY-UP)
AI-Supported, Context-Aware Digital Nudging Intervention to Reduce Ultra-Processed Food Consumption and Improve Dietary Sustainability Among Adolescents and Young Adults (STAY-UP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates the effectiveness of an artificial intelligence (AI)-supported, context-aware digital intervention targeting ultra-processed food (UPF) consumption among adolescents and young adults. UPF consumption has been identified as a major contributor to non-communicable diseases and is associated with significant environmental impacts. However, existing digital nutrition interventions largely rely on static, nutrient-based approaches and do not adequately capture real-life behavioral contexts.
The intervention integrates image-assisted dietary logging, contextual data collection (including time, location, and social setting), and explainable artificial intelligence to identify high-risk moments of UPF consumption. Based on these insights, the system delivers adaptive, personalized digital nudges designed to support healthier and more sustainable food choices without restricting user autonomy.
The study follows a controlled evaluation design to assess the effectiveness of the intervention. Primary outcomes include changes in context-specific UPF consumption patterns, while secondary outcomes include overall dietary quality, sustainability-related indicators (such as environmental impact proxies), and user engagement metrics.
This research aims to provide evidence for scalable, ethically governed digital health interventions that integrate behavioral science, nutrition, and sustainability within real-life settings
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HATİCE MERVE BAYRAM, PhD
- Phone Number: +905549915658
- Email: hmbayram@gelisim.edu.tr
Study Contact Backup
- Name: Arda OZTURKCAN, PhD
- Phone Number: 05356068687
- Email: sozturkcan@gelisim.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents aged 12 to 25 years
- Ownership of a smartphone or regular access to a digital device
- Ability to use the digital intervention platform
- Willingness to provide informed consent (and parental consent where applicable)
- Regular consumption of ultra-processed foods at baseline
Exclusion Criteria:
- Presence of medical conditions requiring a specific therapeutic diet
- Participation in another dietary or behavioral intervention study
- Severe cognitive or psychological conditions that may impair participation
- Inability to use digital tools or applications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (artificial intelligence-supported, context-aware digital nudging intervention)
Participants receive an artificial intelligence (AI)-supported, context-aware digital nudging intervention designed to reduce ultra-processed food (UPF) consumption.
The system uses real-time dietary and contextual data to deliver personalized behavioural prompts.
|
A context-aware digital intervention delivering personalized nudges based on real-time dietary behavior and contextual data to reduce ultra-processed food consumption.
|
|
No Intervention: Control group (Digital platform without nudging)
Participants have access to the digital platform without active nudging components.
No personalized behavioural prompts are delivered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in ultra-processed food consumption (servings per day)
Time Frame: From baseline to 10 months and 20 months
|
Change in ultra-processed food consumption, expressed as servings per day, assessed using dietary intake data collected via a digital dietary assessment platform (food diary-based tracking system).
Consumption will be quantified based on reported frequency and portion size.
|
From baseline to 10 months and 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of ultra-processed food consumption (times per day)
Time Frame: From baseline to 10 months and 20 months
|
Change in the frequency of ultra-processed food consumption, expressed as times per day, assessed using a digital dietary tracking platform (food diary-based system).
|
From baseline to 10 months and 20 months
|
|
Change in proportion of ultra-processed food consumption (% of total intake)
Time Frame: From baseline to 10 months and 20 months
|
Change in the proportion of ultra-processed food consumption, expressed as percentage of total dietary intake, derived from dietary tracking data collected via a digital dietary assessment platform.
|
From baseline to 10 months and 20 months
|
|
Change in temporal eating patterns (eating occasions per day and timing)
Time Frame: From baseline to 10 months and 20 months
|
Change in temporal eating patterns, including number of eating occasions per day and timing of meals, assessed using time-stamped dietary records collected via a digital dietary tracking platform.
|
From baseline to 10 months and 20 months
|
|
Change in context-specific dietary behaviours (categorical variables)
Time Frame: From baseline to 10 months and 20 months
|
Change in context-specific dietary behaviours, including eating location and social context, assessed as categorical variables using data recorded via a digital dietary tracking platform.
|
From baseline to 10 months and 20 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elena Milli, PhD, Polo Europeo della Conoscenza - Istituto Comprensivo di Bosco Chiesanuova
- Study Chair: Stefano Cobello, PhD, Polo Europeo della Conoscenza - Istituto Comprensivo di Bosco Chiesanuova
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAYUP-IGU-2026-CT01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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