Eakin 2013.
Study characteristics | ||
Methods |
Six‐month outcomes from Living Well with Diabetes: A randomized trial of a telephone‐delivered weight loss and physical activity intervention to improve glycemic control Patient RCT, conducted with patients recruited from nine general practices in city of Logan, a largely ethnically and socio‐economically diverse community in the state of Queensland, Australia Two arms: 1. Usual care (control arm) and 2. Telephone counselling (intervention arm) |
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Participants | Control arm N: 151 Intervention arm N: 151 Diabetes type: type 2 Mean age: 58.0 ± 8.6 % Male: 56.3 Longest follow‐up: 6 months |
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Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.5 (1.7), post 7.5 (1.6) Intervention arm: pre 7.4 (1.5), post 7.5 (1.7) |
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Funding source | This study was supported by a National Health and Medical Research Council (NHMRC) project grant and a Diabetes Australia Research Trust grant. Eakin is supported by a NHMRC Senior Research Fellowship; Reeves is supported by a NHMRC Postdoctoral Training Fellowship; Winkler is supported by Queensland Health core infrastructure funding; Healy is supported by a NHMRC/National Heart Foundation of Australia Postdoctoral Fellowship; Dunstan is supported by a VicHealth Public Health Research Fellowship; Owen is supported by a NHMRC Senior Principal Research Fellowship; Marshall is supported by a NHMRC Career Development Award. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Minimisation. |
Allocation concealment (selection bias) | Unclear risk | Minimisation was used; technically you would know to which arm patient was enrolled if based on prognostic variables. |
Patient's baseline characteristics (selection bias) | Unclear risk | They compare baseline to another study: the AusDiab study. |
Patient's baseline outcomes (selection bias) | Unclear risk | They compare baseline to another study: the AusDiab study. |
Incomplete outcome data (attrition bias) | High risk | ~12.6% lost to follow‐up in intervention group; ~7.3% lost to follow‐up in control group. Unbalanced in numbers per group per reason. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: HbA1c. Whole blood samples by high performance liquid chromatography method. |
Selective reporting (reporting bias) | High risk | Some items do not match protocol. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | Information not available. |