Table 1.
Goal of the modification | Who participated in the decision to modify? | What is modified? (nature of content modification) | Fidelity to core elements |
---|---|---|---|
To facilitate weekly monitoring of clinical measurements in the context of prohibited research-related face-to-face interactions |
Principal investigator CHA Participants |
Content: unchanged; clinical measurements were continued on a weekly basis. Context: changed. Original: clinical measurements conducted by the CHA at the FBO Adaptation: clinical measures performed by the participants at home. |
Fidelity: consistent; during the face-to-face format, the visit rate was 95%. This is comparable with the previous cohort where the visit rate was 94.8%. During the adapted online format, the visit rate was 97.8%. |
To facilitate the documentation of clinical measurements to allow the principal investigator to monitor the status |
Principal investigator CHA Participants |
Content: unchanged; clinical data was reviewed on a weekly basis. Context: changed. Original: data was entered by CHAs into the online REDCap database. Adaptation: data was posted by participants in the WhatsApp mobile application and then uploaded by the CHA to the REDCap database. |
Fidelity: consistent; the ability of the PI to monitor hinged on the data entered (see row above). |
To provide participants with an alternative to the liquid low-calorie diet formulation |
Principal investigator CHA Participants Dietician |
Content: unchanged; the daily calorie allowance remained at 840kcal/day. Context: changed Original: diet comprised mainly of a liquid formulation. Adaptation: diet comprised a mixture of solid and liquid formulation. |
Fidelity: partially consistent. One participant experienced some difficulty both sourcing and preparing the solid low-calorie diet. |