Clinical trial NCT06977802: Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University of Parma (MAPHealthS)
Official title: Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University of Parma (MAPHealthS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dietary Fibers
Environmental Impact
Eating Habits
Keywords: dietary fiber
mobile health
sustainable eating
RCT
university students
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dietary Fiber Intake
timeFrame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
Secondary outcomes:
measure: Planetary Diet Adherence
timeFrame: Baseline (T0), after twelve-weeks (T3)
measure: Mediterranean Diet Adherence
timeFrame: Baseline (T0), after twelve-weeks (T3)
measure: Physical Activity Levels
timeFrame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
measure: Diet-Related Environmental Footprint
timeFrame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
measure: Diet-Related Water Footprint
timeFrame: Baseline (T0), after three-weeks (T1), after six-weeks (T2), after twelve-weeks (T3)
measure: App Usability/Satisfaction
timeFrame: Twelve-weeks after enrollment (T3)
measure: Biomarker Validation
timeFrame: Baseline (T0), after three-weeks (T1), after six-weeks (T2)
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Plesso Biotecnologico Integrato
state: PR
Study officials:
affiliation: Università di Parma
name: Francesca Scazzina
role: PRINCIPAL_INVESTIGATOR
References: