Babamoto 2009.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 3 groups 1:1:1 Superiority design
Participants	Inclusion criteria: Hispanic/Latino by self‐report 18 years of age or older Diagnosis of type 2 diabetes (via ADA criteria) within 6 months of study enrolment Exclusion criteria: Participants with gestational diabetes Participants who had previous diabetes case management Diagnostic criteria:
Interventions	Number of study centres: 3 Treatment before study: no Intervention group: a CHW‐led intervention consisting of individual education sessions at participant's home/clinic/community location and supporting telephone calls; education sessions lasted for a 10‐week period (unclear how frequent they were). CHWs were bilingual Hispanics; education sessions were tailored to participant needs—some topics may have been covered more then once, some not at all, depending on participant needs; telephone calls were made 'routinely' during this period and then for 14 weeks after the intervention (up to 6 months). The second intervention group received case management by culturally sensitive nurses Control group: received no extra contact
Outcomes	Outcomes reported in abstract of publication: HbA1c BMI Diabetes knowledge Emergency department admissions Physical activity Medication‐taking behaviour Dietary intake (incl. fruit and vegetable intake and fatty food intake) Health status Primary outcome(s): Secondary outcome(s): Outcome measures were assessed at completion of the 6‐month intervention programme
Study details	Run‐in period: unclear 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: "Evaluate the relative effectiveness of a CHW intervention among Hispanic persons with newly diagnosed type 2 diabetes (compared with case management and usual care)"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: randomisation via a "random‐number table"
Allocation concealment (selection bias)	Unclear risk	Comment: not commented upon
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: no one was blinded—participants, providers or outcome assessors
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: no one was blinded—participants, providers or outcome assessors
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: no one was blinded—participants, providers or outcome assessors; unlikely to affect objective measurement of HbA1c, but BMI can be more subject to bias in measurement (e.g. rounding differences)
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: no blinding
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Comment: not an ITT analysis. High attrition rate and differences between groups (43%‐50% control and 28% intervention)
Incomplete outcome data (attrition bias) Subjective outcomes	High risk	Comment: as above
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none