Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Milano Bicocca | OTHER |
Not provided
Not provided
Not provided
The goal of this randomized controlled trial is to evaluate the effectiveness of a mobile app (MAPHealthS) in promoting healthy and sustainable eating habits among university students at the University of Parma. The study aims to answer the following questions:
Does the use of the educational mobile app increase daily fiber intake among students?
Does the app improve adherence to sustainable and healthy diets (e.g., Mediterranean and Planetary diets)?
What are the effects of the app on physical activity levels, anthropometric measures, and the environmental impact of participants' diets?
Researchers will compare the intervention group (using the app) to a control group (no intervention) over a 12-week period, including a 6-week active phase and a 6-week follow-up phase.
Participants will:
Download and use the app (intervention group) or follow no intervention (control group) for 12 weeks.
Complete dietary assessments (24-hour recalls, food frequency questionnaires), provide urine and fecal samples, and undergo anthropometric measurements at multiple time points.
Wear actigraphs (a subgroup) to measure energy expenditure.
Answer questionnaires on dietary habits, physical activity, and app usability.
The study expects to see a significant increase in fiber intake (7g/day) and improved sustainability awareness among app users.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention: Participants use the UNIPLATE mobile app, a tailored educational tool designed to promote healthy and sustainable eating. Features: Daily nutrition/sustainability tips, meal planning, recipe suggestions (prioritizing plant-based foods), gamified challenges, and progress tracking. Delivery: 6-week active phase with daily app notifications, followed by 6-week follow-up (no notifications). Tailoring: Content adapts to baseline food-related psychobehavioral profiles (assessed via questionnaire). Support: Developed with input from nutritionists, psychologists, and computer scientists (University of Parma). |
|
| Control | No Intervention | Intervention: No app or active intervention; participants maintain habitual dietary behaviors. Monitoring: Completes identical assessments (dietary recalls, biomarkers, anthropometrics) as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Nutrition Education Mobile App for Healthy and Sustainable Eating | Behavioral | This intervention is uniquely characterized by: Dual Health-Sustainability Focus - Unlike most nutrition apps targeting weight loss, this integrates planetary health metrics (e.g., carbon/water footprints) alongside dietary guidance. Psychobehavioral Personalization - Content is tailored to four predefined user profiles (e.g., "Convenience-Seeker," "Health-Conscious") identified through baseline questionnaires, adapting messaging strategies (e.g., time-saving tips vs. environmental appeals). Biomarker-Validated Outcomes - Unlike apps relying solely on self-reports, efficacy is assessed via objective measures (urinary LC-MS metabolomics, fecal microbiota analysis). Academic Development - Designed by nutrition scientists + AI engineers (University of Parma), with recipes aligned to Mediterranean/Planetary Diet standards |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Fiber Intake | The primary outcome measures the change in participants' daily dietary fiber intake (grams/day) after using the nutrition education mobile app for 6 weeks, compared to baseline and control group levels, using 24-hour dietary recalls and food frequency questionnaires. | Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Planetary Diet Adherence | Measures improvement in adherence to a sustainable diet using the Planetary Health Diet Index (PHDI) score, calculated from the food frequency questionnaire. The PHDI score ranges from 0 to 150, with higher scores indicating better adherence to planetary health diet, defined by the EAT-Lancet Commission. | Baseline (T0), after twelve-weeks (T3) |
Not provided
Inclusion Criteria:
University students (undergraduate/graduate) at the University of Parma Age 18-29 years Italian nationality and residence in Italy Baseline fiber intake <17.7g/day (below Italian average) Ownership of an iOS/Android smartphone with internet access No current use of nutrition/health tracking apps
No self-reported:
Exclusion Criteria:
Not University students (undergraduate/graduate) at the University of Parma Not Aged 18-29 years Not Italian nationality and residence in Italy Baseline fiber intake >17.7g/day (over Italian average) Not ownership of an iOS/Android smartphone with internet access Current use of nutrition/health tracking apps
Self-reported:
Not signed informed consent
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesca Scazzina | Università di Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plesso Biotecnologico Integrato | Parma | PR | 43121 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, parallel-group controlled trial with a 12-week duration (6-week active intervention + 6-week follow-up). Participants (n=60) are university students with low baseline fiber intake, randomly assigned to:
Intervention group (n=30): Uses a tailored mobile app (MAPHealthS) with nutrition education, meal planning, and sustainability tips.
Control group (n=30): No intervention.
Key features:
Blinding: Single-blind (outcome assessors may be blinded; participants are aware of group allocation).
Data collection: Dietary intake (24h recalls, FFQs), biomarkers (urine/fecal), anthropometrics, and actigraphy (subgroup).
Primary outcome: Change in daily fiber intake (g/day).
Secondary outcomes: Diet sustainability scores, physical activity, body composition, and environmental impact.
Not provided
Not provided
Not provided
Not provided
|
| Mediterranean Diet Adherence | Assesses increased adherence to Mediterranean diet principles using the validated MedScore index. The MedScore ranges from 0 to 25, with higher scores indicating better adherence to the Mediterranean diet. | Baseline (T0), after twelve-weeks (T3) |
| Physical Activity Levels | Tracks changes in weekly physical activity using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week (1 MET = energy expended at rest), ranging from 0 to 10,000+, with higher scores indicating more activity. Participants are also classified into low (<600 MET-min/week), moderate (600-2999), or high (≥3000) activity levels. | Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3) |
| Diet-Related Environmental Footprint | Diet-related Carbon Footprint: Measured in kg CO₂eq/day, this indicates the total greenhouse gas (GHG) emissions associated with the diet. It is assessed based on 24-hour recalls and the SU-EATABLE LIFE database, a comprehensive resource for the carbon and water footprints of food products. Lower values reflect a reduction in carbon emissions. | Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3) |
| Diet-Related Water Footprint | Diet-related Water Footprint: Measured in liters/day, this indicates the total water consumption associated with the diet. It is assessed based on 24-hour recalls and the SU-EATABLE LIFE database, which provides comprehensive data on the water footprints of food products. Lower values reflect a reduction in water usage. | Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3) |
| App Usability/Satisfaction | The usability and satisfaction of the app will be assessed using the validated mHealth Satisfaction Questionnaire (a questionnaire for assessing user satisfaction with mobile health apps, developed by Melin et al., 2020, using rasch measurement theory. In addition to the these questions, several case-specific questions were added to tailor the assessment to the app's unique features. Participants will also be asked open-ended questions to gather qualitative feedback on their experience. The scale uses Likert-type responses (e.g., 1 = Strongly Disagree to 5 = Strongly Agree), and the responses will be analyzed to identify patterns in user satisfaction and usability. Higher scores reflect greater satisfaction and perceived usability. | Twelve-weeks after enrollment (T3) |
| Biomarker Validation | Validates dietary changes through: Urinary liquid chromatography-mass spectrometry (LC-MS) metabolomics (polyphenol metabolites) Fecal microbiota analysis (16S rRNA sequencing) | Baseline (T0), after three-weeks (T1), after six-weeks (T2) |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided