In this task a general framework for the pilot studies will be designed and provided by MEDRI to the three European countries organising pilot studies (Spain – FISABIO, Croatia-MEDRI and The Netherlands-EMC). MEDRI will provide the general framework together with practical guidelines on how to adapt the general concept to each pilot site requirements and target groups.

Pilot site leaders (FISABIO, MEDRI and EMC) will also have to work on some preparatory activities:

1) Obtention of the ethical approval at each pilot site. The procedures to obtain Ethical approval will be started immediately at the beginning of the project in close relation with FISABIO in order to ensure that it is obtained before the enrolment of the first study participant.

2) To build up community connections with local stakeholders that will be involved in the pilot studies, so regular communication and interaction structure will be ensured to support the target groups during the pilot studies.

3) Develop training activities for HORUS professionals and staff involved in each pilot center to use the ICT tool and to explain the model and how to apply it in a complementary way to the implementation of cognitive behavioural interventions as tools to support and monitor progress in behavioural change and the acquisition of healthy lifestyles. Based on the results obtained on the association between the characteristics of the environment, the causal links that drive this association and the co-design processes on the barriers and facilitators that drive the relationship of the target population with their urban environment, the coordinating partner MEDRI together with the technical partners will provide the general framework for implementation of the cognitive-behavioural model along with practical guidelines for its appropriate adoption in each of the pilot sites.

In this way, the pilot partners (FISABIO, MEDRI, EMC) will implement the cognitive-behavioural intervention model supported by the Wakamola digital solution (developed by UPV) according to the results obtained in WP2 and WP3 (led by UVEG and BAX, respectively). Thus, each partner (FISABIO, MEDRI, EMC) will define the implementation plan to be carried out according to the urban characteristics and the socio-health needs of the target population.

T4.2. Pilot studies (Task leader: MEDRI; Contributing partners: All). Once the preparatory activities are completed in pilot sites, Sept 2025 -June 2026, FISABIO, MEDRI and EMC will be ready to start with the HORUS intervention implementation. For 9 months, MEDRI will coordinate the activities for the inclusion of vulnerable populations at risk of developing noncommunicable diseases or affected by noncommunicable diseases, with a special focus on diabetes and cardiovascular diseases in interventions and will monitor the intervention phase in each pilot site. Moreover, MEDRI will be responsible for coordinating the activities for correct data collection. The pilot testing phase will include the following steps:


Step 1

Given that this is a longitudinal trial, the sample selection will be assigned to the different intervention modalities simultaneously, with a total of 300 participants for each pilot site, 150 for the control group and 150 for the intervention group, following the methodology described in the corresponding section.

Step 2

This step will include the installation of the Wakamola chatbot in a secure server following the instructions of the ethical committees and the data protection officer, the deployment of the chatbot in the platforms of the digital social networks in the market (e.g. Telegram) and the support of the user to access the chatbot.

Step 3

UPV will generate an online tutorial for the pilot coordinators and for the final users of the pilots. This tutorial will be accessible online to the community in case the need to clarify any technical aspect of the chatbot or social network. A technician from UPV will prepare a monthly report to coordination and communication of  the project summarising the number of users, number of acquisitions, missing data and incidences stratified by pilots to check the correct activity of the social network among the study.