| Larsen 2011 |
Low risk of bias |
" Randomisation was carried out by a third party using computer‐generated random numbers (using block randomisation and random block sizes) and stratified according to diabetes treatment..." "Dietary assignment was performed by a third party on the day of the initial dietary counselling visit." "The baseline characteristics for the intention‐to‐treat population were well‐matched at baseline...although non‐significant differences were apparent in calcium excretion rate, systolic blood pressure and the proportion of men." |
Low risk of bias |
"...we were not able to blind participants or the study personnel involved in dietary counselling." Deviations reported are expected to arise in usual care, e.g. lost interest, dissatisfied with weight loss. Modified ITT analyses conducted: "...study staff encouraged all participants to return for follow‐up assessments of primary and secondary outcomes, regardless of dietary adherence." |
Low risk of bias |
9/57 (16%) participants in the intervention group and 6/51 (12%) in the control group did not have data available. Data imputed for ITT for 5/57 (intervention) and 1/51 (control) participants with missing data. "This study used the single imputation method of last measurement carried forward for missing data for primary and secondary outcomes." Based on reasons provided, it is unlikely that missingness in data for DBP was influenced by its true value. |
Low risk of bias |
Study authors reported that a mercury sphygmomanometer was used. No evidence that a different method was used across intervention groups to measure DBP. "...(anthropometrics and laboratory variables) were measured by personnel who were blinded to group allocation..." |
Some concerns |
No mention of pre‐specified data analysis plan, and trial registry does not mention the outcome and timepoint in any versions thereof "Study endpoints were assessed blinded to the diet group, but the statistical analysis was performed unblinded." Analysis intentions are not reported in sufficient detail to enable an assessment. |
Some concerns |
Lack of information in the pre‐registered methods. |
