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Completed

NCT Number: NCT06977802

Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University of Parma (MAPHealthS)

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.

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Key information

Conditions

Dietary Fibers Behavior Behavior, Animal Eating Habits Environmental Impact Feeding Behavior

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plesso Biotecnologico Integrato

Parma, PR, 43121, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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:

  • Chronic diseases (diabetes, metabolic disorders)
  • Eating disorders
  • Use of medications for hypertension/dyslipidemia
  • Antibiotic/probiotic use in past 4 weeks
  • Following prescribed diets or meal plans
  • Pregnant/lactating

Not signed informed consent

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Planetary Diet Adherence

    Time frame: Baseline (T0), after twelve-weeks (T3)

    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.

  2. Mediterranean Diet Adherence

    Time frame: Baseline (T0), after twelve-weeks (T3)

    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.

  3. Physical Activity Levels

    Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)

    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.

  4. Diet-Related Environmental Footprint

    Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)

    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.

  5. Diet-Related Water Footprint

    Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)

    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.

  6. App Usability/Satisfaction

    Time frame: Twelve-weeks after enrollment (T3)

    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.

  7. Biomarker Validation

    Time frame: Baseline (T0), after three-weeks (T1), after six-weeks (T2)

    Validates dietary changes through:

    Urinary liquid chromatography-mass spectrometry (LC-MS) metabolomics (polyphenol metabolites)

    Fecal microbiota analysis (16S rRNA sequencing)

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • University of Milano Bicocca

Registry information

Acronym: MAPHealthS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
Jul 30, 2025

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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