The objectives of the project have not changed, and the project progress continues to be according to plan as well as the objectives being up-to-date and realistic.
The most significant outcome and highlight in this first interim reporting period is that the central tool of this project, the VEGANScreener, was developed on schedule by the end of December 2022 (Deliverable 4), using a structured process. To do this, our approach combined best practices for developing nutrition quality metrics with approaches to scale development and included: a) a literature synthesis on nutrition and health outcomes (Deliverable 3); b) an expert review of the evidence; and c) translation of the evidence into a measurement tool. We used a modified Delphi technique to solicit international expert opinion, which involved identifying a pool of items in different domains of diet quality, followed by two rounds of online feedback and voting, and a final online consensus session that led to the conversion of the items into measurable indicators of diet quality. This instrument (VEGANScreener) was subsequently translated into the 4 national languages of the participating centers (German, Dutch/Flemish, Spanish, and Czech) in an iterative process.
In a parallel, the study protocol for the field studies was established (Deliverable 1), and positive ethics committee votes were obtained in the 4 participating countries, the Consortium Agreement and Data Transfer Agreements were drafted in coordination with the respective legal departments and signed by all partners, and the required questionnaires and instruments were drafted and subsequently transferred to RedCap in 4 languages in close collaboration with the teams around the PIs of the respective countries where data are collected (Germany, Czech Republic, Belgium, and Spain). The start of the field study could therefore take place with a delay of one month but still approximately on schedule on April 1, 2023 and the data collection will run until autumn/end of 2023.
As far as we have seen so far, now that the first approx. 246 subjects have been brought into the study (152 in Czech Republic, 94 in Spain), we are pleased to report that there have been no significant problems to date. The process of entering the data into the prepared RedCap portal has worked very well so far, especially but not only because the on-site training of the subjects by the teams of field study leaders was carried out according to protocol and the respective procedures had been trained accordingly in advance. A video was produced in which the complex blood samples were presented in detail in order to provide the respective study centers with a standardized procedure. On May 3, we had our six-month consortium meeting, which also included our advisory board meeting. We discussed the procedures with the 3-member international Advisory Board and presented the progress in subject recruitment in order to obtain the feedback of this group of experts.