| Watson 2016 |
Low risk of bias |
Participants were randomly allocated by an investigator, who had no participant contact, using the process of minimisation." "An independent holder of the randomisation schedule will perform treatment allocation without contact with the volunteers." (trial registry). "All p values [for baseline characteristics] are > 0.05 for between group differences based on independent t‐tests." |
Low risk of bias |
Trial registry: Open (masking not used). Deviations reported are expected to arise in usual care e.g. work commitments, unable to continue with diet. Modified intention to treat analysis; including participants who commenced and completed the study irrespective of compliance, only two participants were not included as they withdrew after randomisation but before the start of the study. |
High risk of bias |
9/32 (28%) participants in the intervention and 10/31 (32%) participants in the control arm did not have data available. "Sensitivity analysis was conducted for the BMI, fat mass (kg), and DBP variables using two methods: all participants who commenced the study and completers only. Both analyses showed the same pattern of outcomes with a time effect (p<0.001) but no differences between the groups (>=0.51)or group by time interactions (>=0.07). This implies that our linear mixed effects analysis has accurately modelled the missing data and the baseline differences have not had an adverse influence on our conclusions." High attrition in both groups, with reasons including personal reasons, unable to comply with the intervention. It is likely that with such high attrition, missingness is possibly and likely to depend on the true value. |
Low risk of bias |
"Body mass was measured twice using calibrated electronic scales (Tanita Ultimate Scale 2000; Tokyo)." No evidence that different methods were used across intervention groups to measure weight. "The investigator was trained in ISAK International Standards for Anthropometric Assessment". Trial registry: Open (masking not used). Weight is not an observed‐reported outcome involving judgment. |
Some concerns |
No mention of pre‐specified analysis plan, but trial registry at date prior to study publication mentions the outcome and timepoint. The time point mentioned in trial registry at date prior to publication is reported on in publication. Analysis intentions are not reported in sufficient detail to enable an assessment. |
High risk of bias |
High attrition reported in both groups, including 'personal reasons' and 'inability to comply with interventions'; therefore missingness is possibly and likely dependent on the true value of the outcome. Lack of information in the pre‐registered methods. |
