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

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)
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
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
Outcomes 1) Statins
2) Antihypertensives (any)
3) Glycated haemoglobin
4) Systolic blood pressure
5) Diastolic blood pressure
6) Low‐density lipoprotein
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.