Dietary FibersMAPHealthSNCT06977802
Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University of Parma (MAPHealthS)
A study testing Digital Nutrition Education Mobile App for Healthy and Sustainable Eating in people with Dietary Fibers and Environmental Impact, run by University of Parma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Fibers, Environmental Impact, Eating Habits
- What is being tested?
- Digital Nutrition Education Mobile App for Healthy and Sustainable Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2024to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Chronic diseases (diabetes, metabolic disorders)
- Eating disorders
- Use of medications for hypertension/dyslipidemia
- No antibiotic/probiotic use in past 4 weeks
- Not following prescribed diets or meal plans
- Not pregnant/lactating Signed informed consent
Who cannot join
- 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:
- Chronic diseases (diabetes, metabolic disorders)
- Eating disorders
- Use of medications for hypertension/dyslipidemia
- Antibiotic/probiotic use in past 4 weeks
Show all 9Show fewer
- Following prescribed diets or meal plans
- Pregnant/lactating
- Not signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Dietary Fibers, Environmental Impact, Eating Habits
- Being tested
- Digital Nutrition Education Mobile App for Healthy and Sustainable Eating
- Keywords
- dietary fiber, mobile health, sustainable eating, RCT, university students
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Nutrition Education Mobile App for Healthy and Sustainable EatingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Digital Nutrition Education Mobile App for Healthy and Sustainable Eating |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
Secondary outcomes (7)
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.
Measured: Baseline (T0), after twelve-weeks (T3)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline (T0), after three-weeks (T1), after six-weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start4 Nov 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary FibersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Principal investigator, Francesca Scazzina Ph.D., University of Parma
- Investigators
- Francesca Scazzina, Principal investigator, Università di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977802
- Sponsor's protocol ID
- UNIPLATE
- Acronym
- MAPHealthS
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University of Parma (MAPHealthS)
- ClinicalTrials.gov ID
- NCT06977802
- Acronym / sponsor ID
- MAPHealthS / UNIPLATE
- Conditions
- Dietary Fibers, Environmental Impact, Eating Habits
- Keywords
- dietary fiber, mobile health, sustainable eating, RCT, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 18 May 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digital Nutrition Education Mobile App for Healthy and Sustainable EatingIntervention: 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- Chronic diseases (diabetes, metabolic disorders)
- Eating disorders
- Use of medications for hypertension/dyslipidemia
- No antibiotic/probiotic use in past 4 weeks
Key exclusion criteria (9 listed)
- 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
- Chronic diseases (diabetes, metabolic disorders)
- Eating disorders
- Use of medications for hypertension/dyslipidemia
- Antibiotic/probiotic use in past 4 weeks
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 |
|---|---|---|
| Digital Nutrition Education Mobile App for Healthy and Sustainable EatingThis 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 | Behavioural | Intervention |
Primary outcome
Dietary Fiber Intake
Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
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.
7 secondary outcomes
Planetary Diet Adherence
Time frame: Baseline (T0), after twelve-weeks (T3)
Mediterranean Diet Adherence
Time frame: Baseline (T0), after twelve-weeks (T3)
Physical Activity Levels
Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
Diet-Related Environmental Footprint
Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
Diet-Related Water Footprint
Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
App Usability/Satisfaction
Time frame: Twelve-weeks after enrollment (T3)
Biomarker Validation
Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Francesca Scazzina principal investigator
Università di Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Nutrition Education Mobile App for Healthy and Sustainable Eating in people with Dietary Fibers and Environmental Impact, run by University of Parma at 1 site in Italy.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jul 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dietary Fiber Intake (time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.