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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
Interventions Control arm:
1) Patient education
Intervention arm:
1) Case management
2) Promotion of self‐management
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)
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.