Brown 2002.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 1:1 Equivalence design
Participants	Inclusion criteria: Not having participated in previous intervention 35 to 70 years of age Having type 2 diabetes from 35 years of age Willing to participate Exclusion criteria: Pregnancy Medical conditions preventing changes in diet and exercise Diagnostic criteria: 2 verifiable FBG test results > or equal to 140 mg/dL or Taking or have taken insulin or oral hypoglycaemic agents for 1 year or longer in the past
Interventions	Number of study centres: Roasters in Starr County, Texas Treatment before study: none had participated in any intervention previously Intervention: 3 months weekly group educational sessions, 6 months biweekly support sessions and thereafter 3 months monthly support sessions Control: usual care from their private physicians or at local clinics Providers: bilingual Mexican American dietician, nurse and community health worker
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Diabetes knowledge Health beliefs HbA1c FBG Lipids BMI Secondary outcome(s): None stated as secondary outcome
Study details	Run‐in period: not stated Study terminated before regular end (for benefit/because of adverse events): no
Publication details	Language of publication: English Funding: National Institute for Diabetes and Kidney Disease and the Office of Research on Minority Health, National Institute of Health and the State of Texas Publication status: peer review journal
Stated aim of study	Quote from publication: "To determine the effects of culturally competent diabetes self‐management education on diabetes‐related knowledge, health beliefs, HbA1c, lipids and BMI"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: no specific comment on method of randomisation
Allocation concealment (selection bias)	Unclear risk	Comment: not commented on
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: not specifically mentioned but participants unlikely to have been blinded given study design. At high risk of performance bias
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: not specifically mentioned but participants unlikely to have been blinded given study design. At high risk of performance bias
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: presumed lack of blinding unlikely to affect the objective outcomes measured
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: although attempts made to train assessors to be non‐biased, self‐reported subjective measures in non‐blinded participants = high risk
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: not specifically commented on, but attrition rate appears to be about ˜10% from the n values in the data tables
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: not specifically commented on, but attrition rate appears to be about ˜10% from the n values in the data tables
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none