Middelkoop 2001.

Methods	Parallel randomised controlled clinical trial (RCT) (for first 6 months) Randomisation ratio: 53 intervention:60 control Superiority design
Participants	Inclusion criteria: South Asian origin Type 2 DM No co‐morbidity interfering with interpretation of metabolic control (i.e. recent miocardial infarction or dementia) Visited attending clinic during first half of the year 1998 Exclusion criteria: not stated Diagnostic criteria: not stated
Interventions	Number of study centres: 3 general practices and 1 outpatient clinic Treatment before study: not stated Intervention: attending to intensive guidance clinics (approximately 4‐7 visits for the first 3 months, with less frequent subsequent visits) provided by trained nurse and dietician Control: wait‐listed group that joined the intervention group after 6 months Provider: specialist nurse and dietician trained in South Asian culture
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): HbA1c Secondary outcome(s): not assessed for RCT component of the intervention
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: not stated Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To assess if culturally‐specific diabetes intervention led to a decrease HbA1c level, improvement in lipid profile, or a decrease in BMI"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote from publication: "Patients were randomised based on their date of birth: odd numbers (intervention patients)"
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	Comment: not clear whether participants would have been aware of whether they were in the control group
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: does not mention whether laboratory technicians blinded but unlikely to have affected HbA1c
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: 28/60 of control group lost to follow‐up as changed GP, does not provide further details of other participants lost to follow‐up
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Selective reporting (reporting bias)	Unclear risk	Comment: HbA1c was only outcome in RCT reported on but protocol not seen (e.g. may have specified that investigators would look at BMI at 6 months)
Other bias	Unclear risk	Comment: none