NCT06977802

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

March 24, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

dietary fibermobile healthsustainable eatingRCTuniversity students

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (7)

  • Planetary Diet Adherence

    Baseline (T0), after twelve-weeks (T3)

  • Mediterranean Diet Adherence

    Baseline (T0), after twelve-weeks (T3)

  • Physical Activity Levels

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

  • Diet-Related Environmental Footprint

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

  • Diet-Related Water Footprint

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

  • +2 more secondary outcomes

Study Arms (2)

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).

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.

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plesso Biotecnologico Integrato

Parma, PR, 43121, Italy

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Francesca Scazzina

    Università di Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

May 18, 2025

Study Start

November 4, 2024

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations