Procedure and ethics
Newton
MAY, BLIND
The study was conducted between January 2017 and May 2018. Following the abovementioned procedure, once a patient was enroled in the study, the baseline evaluation was conducted. When all the participants were recruited, the cluster randomisation was produced by an external researcher. The study allocation was blind for the GPs, who continued providing the TAU to the participants, as well as for the evaluators to ensure the single‐blind nature of the study. Restricted randomisation was applied to balance clusters, creating comparable arms in terms of the number of clusters but also in the average per capita income of the assigned population to each PC centre, since this variable is inversely related to the presence of overweight and obesity (Newton et al., All study information was confined in secure drawers with limited access. Participant codes and personal information were stored in a separate password‐protected file, and electronic data files were password‐protected and secured via advanced encryption standard. This study was approved by the ethical committee of Aragon, Spain (PI19/086; 27/04/2016). All procedures performed in this study were in accordance with the criteria of the 1964 Declaration of Helsinki and subsequent amendments. The data were treated anonymously and were only used for the purposes of the study. The confidentiality of participants was guaranteed and protected by the Spanish Organic Law on Protection of Personal Data and Guarantee of Digital Rights (3/2018 of December 7), and all relevant EU legislation on privacy and data protection. This trial (