ActivE³ - Everyone, Everywhere, Everyday WP 2 - Personalized Data-driven Coaching Platform for Stimulating and Promoting Active Lifestyle and Health Risk Prevention

NCT07350915 | Completed

• 1 other identifier: Active3-WP2
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of WP2 of the Active3 project is to develop a digital solution for promoting and monitoring physical activity in social settings (real or virtual) that implements a Preventive Medicine approach to healthy aging. Specifically, the objective of the action related to Word Package 2 is to develop a personalized, data-driven coaching platform co-designed with local healthcare services, clinicians, technologists, designers, and management engineers to stimulate and promote an active lifestyle and prevent health risks among the over-60 population in Lecco and its province. Active Healthy Aging initiatives, such as the Walking Groups coordinated by local healthcare services, are already active in the Lecco area. This personalized coaching platform aims to leverage these initiatives for prevention and treatment purposes. Its objectives are:

• Creating a user-friendly technological tool for local healthcare services/clinical organizations for projects encouraging physical activity as a driver of lifestyle-based prevention;
• Test this digital therapeutic practice (with a clinical study) on a cohort of 200 individuals to validate its usability, adherence and preliminary efficacy. The main questions it aims to answer are: Will a Digital Therapeutics (DTx) based on Active Lifestyle and balance nutrition promotion be adopted and used in an elderly propulation? What outcomes in health scores will Active3-WP2 platform achieve in physical, metabolic and cognitive domains? Researchers will compare the use of the proposed DTxA to a contrl gropu receiving a standard educational program. Participants will:
• receive the Active3-WP2 platform (App+ Wearable)
• participate in health screenings at month 0, month 6 and month 12.

Conditions

Healthy

Keywords

Prevention

Outcome Measures

Primary Outcomes (4)

• Adherence to the DTx

  Adherence to the proposed DTx measured as % of people using the App with at least 1 access per week and 20 minutes per week. A percentage of individuals still active in following the proposed path of 70% in the intervention group is considered satisfactory.

  From enrollment to the end of treatment at 12 months

• Adherence to the DTx

  Adherence to the proposed DTx measured as number of routes taken. Adherence will be measured as average number of routes taken (in the total population). A number of walked paths of \>25 in the intervention group is considered satisfactory.

  From enrollment to the end of treatment at 12 months

• Usability

  Usability is considered as satisfaction of use. The satisfaction will be measured by the System Usability Scale (SUS). An average SUS score \> 75 in the intervention group is considered satisfactory

  From enrollment to the end of treatment at 12 months

• Quality of life score

  Assessment of quality of life using the SF-36 scale at times 0, 6 and 12 months in all groups. The SF-36 score provides a 1-100 range score. For each participant will be computed the percentage difference in the score at 6 months and 12 month in comparison to the baseline score. The quality of life endpoint (SF-36) is considered satisfactory with a 10% increase pre- and post-intervention (12 months),

  From enrollment to the end of treatment at 12 months.

Secondary Outcomes (6)

• Preliminary assessment of the clinical efficacy of the behavioral intervention

  From enrollment to the end of treatment at 12 months

• Preliminary assessment of the clinical efficacy of the behavioral intervention

  From enrollment to the end of treatment at 12 months

• Preliminary assessment of the clinical efficacy of the behavioral intervention

  From enrollment to the end of treatment at 12 months

• Preliminary assessment of the clinical efficacy of the behavioral intervention

  From enrollment to the end of treatment at 12 months

• Preliminary assessment of the clinical efficacy of the behavioral intervention

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

DTx adopters.

Device: Digital Therapeutics

Control Group

NO INTERVENTION

Administered with only standard educational program

Interventions

Digital Therapeutics DEVICE

coaching App for the promotion of physical activity and balanced nutrition based on Mediterranean diet scheme as a prevention tool for healthy ageing in the 60-80 age group.

Intervention Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 60 and 80 years.

You may not qualify if:

• Presence of pathologies, in particular cardio-respiratory diseases, of such severity to prevent the execution of the physical tests and activities promoted by the DTx
• Inability to consent to participate in research.

Sponsors & Collaborators

• Politecnico di Milano: lead

Study Sites (1)

Politecnico di Milano - Polo Territoriale di Lecco

Lecco, Lecco, 23900, Italy

Location

Study Design

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

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)