Protocol Amendments
fatigue
RECRUITMENT
Owing to the recruitment processes being heavily reliant on parents’ literacy levels to provide informed consent, a video communicating the study information was embedded into the recruitment materials. This amendment was implemented 2 weeks into recruitment, following feedback from stakeholders that the original recruitment methods were restrictive. Furthermore, the recruitment phase was extended from 2 to 12 weeks because of slow uptake. Extensions were incrementally increased as part of the review process (eg, every 2 weeks). This rate was somewhat accelerated by adapting the recruitment materials; however, given that the trial was conducted during the peak of the COVID-19 pandemic in Brazil, there are likely several contextual factors outside the researchers’ control that led to lower than anticipated uptake (eg, screen and social media fatigue) [