Outcome | Definition | Data source |
---|---|---|
Recruitment | % of enrolled participants (children) from those that were eligible and invited to participate. | Recruitment records kept by researchers in excel files and REDCap, class rolls. |
Retention | % of enrolled participants (children) completing follow-up data collection (questionnaires) | Data collection records kept by researchers in REDCap |
Data collection and analysis | % of enrolled participants (children) completing questionnaires and cognitive assessment which were valid for analysis | Data collection records kept by researchers in REDCap. |
Biological sample collectiona | % of participants (children) opting in for stool sample collection, and % completing baseline and follow-up sample collection. | Recruitment and data collection records kept by researchers in REDCap. |
Intervention implementation | Dose delivered and fidelity of study processes and intervention as planned. | Process evaluation tools – Core components checklist. |
Intervention acceptability | Acceptance and satisfaction of study processes and intervention. | Process evaluation tools – End of lesson (children) or intervention (parents, teachers) surveys. |