| Random sequence generation (selection bias) |
Low risk |
“Randomization was by permuted block” |
| Allocation concealment (selection bias) |
Unclear risk |
Randomization by sealed envelopes, not clear if opaque. |
| Blinding of participants and personnel (performance bias) |
High risk |
Blinding of participants and personnel was not possible due to the nature of the intervention and study design. |
| Blinding of outcome assessment (detection bias) |
Unclear risk |
No description of blinding of outcome assessment was provided. |
| Incomplete outcome data (attrition bias) |
Unclear risk |
Insufficient reporting of attrition/exclusion (no reasons for missing data provided). Lost to follow‐up reported at 7 months, not at 14 months. Reasons for attrition reported only for the experimental sample. |
| Selective reporting (reporting bias) |
Low risk |
No evidence of reporting outcome selectively was detected. |
| Other bias |
Low risk |
No evidence of other biases was detected. |