Andrews 2011.
Study characteristics | ||
Methods |
Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial Patient RCT, conducted in 5 secondary care National Health Service trusts: Taunton and Somerset NHS Foundation trust, University Hospitals Bristol NHS Foundation trust, North Bristol NHS Trust, Gloucestershire Hospitals NHS Trust, and Weston Area Health NHS Trust, United Kingdom. Three arms: 1) Usual care (control arm), 2) Intensive dietary intervention (intervention arm 1) and 3. Intensive dietary intervention and activity (intervention arm 2) |
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Participants | Control arm N: 99 Intervention arm 1 N: 248 Intervention arm 2 N: 246 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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Interventions |
Control arm: None Intervention arm 1: 1) Team changes 2) Patient education 3) Promotion of self‐management Intervention arm 2: 1) Team changes 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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Outcomes | 1) Statins 2) Antihypertensives (any) 3) Glycated haemoglobin 4) Systolic blood pressure 5) Diastolic blood pressure 6) Low‐density lipoprotein |
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Funding source | This study was funded by Diabetes UK and the UK Department of Health | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "computer‐generated allocation", but unsure if this included generation of sequence. |
Allocation concealment (selection bias) | Low risk | Quote: "computer‐generated allocation." |
Patient's baseline characteristics (selection bias) | Low risk | Quote: "characteristics of enrolled patients in all groups were similar at baseline", in text but not in table. |
Patient's baseline outcomes (selection bias) | Low risk | Quote: "characteristics of enrolled patients in all groups were similar at baseline." Includes outcomes of interest. |
Incomplete outcome data (attrition bias) | Low risk | Intention‐to‐treat analysis done, attrition very low, reasons for loss to follow‐up provided and proportions are unlikely to reflect outcomes. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary: HbA1c and blood pressure: measures not described, and blinding of outcome assessor not described. Secondary: outcome assessors not blinded for medication. |
Selective reporting (reporting bias) | Low risk | Checked protocol, everything proposed was conducted. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | Information not available. |