DePue 2013.

Methods	Cluster‐randomised controlled clinical trial (RCT) Randomisation ratio: 1:1 (village clusters) Superiority design
Participants	Participants were 268 nationals of American Samoa with type 2 diabetes Inclusion criteria: aged 18 or older, resident in service area, self‐identity as Samoan, physician diagnosis of T2DM, mentally competent and able to consent, unlikely to leave American Samoa for over 4 months, no serious co‐morbidities (e.g. ESRF, cancer) Exclusion criteria: as above Diagnostic criteria: "physician diagnosed" type 2 diabetes
Interventions	Number of study centres: 1 Treatment before study: not commented upon The intervention was individual education tailored to a person's self‐goals and diabetes risk over the course of a year. Frequency varied depending on risk, from monthly to yearly. Teaching was delivered by nurses and community health workers. High‐risk patients were also seen in group sessions. Intervention occurred at home, at work or at the Tafuna clinic. Control arm received delayed intervention of 12 months. In meantime, they received usual care. Included a telephone call at 6 months to update contact info and encourage participation
Outcomes	Outcomes reported in abstract of publication: Primary outcome: HbA1c Secondary outcomes: Body mass index Blood pressure Waist circumference
Study details	Run‐in period: recruiting between February 2009 and May 2010. No details on when intervention commenced Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Institute of Diabetes, Digestive, and Kidney Disorders (R18‐DK075371) Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To evaluate the effectiveness of a culturally adapted, primary care–based nurse–community health worker (CHW) team intervention to support diabetes self‐management on diabetes control and other biologic measures"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: no data
Allocation concealment (selection bias)	Unclear risk	Comment: no data
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	Comment: no data
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Comment: no data
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: no data
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: no data
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: no data
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: no data
Selective reporting (reporting bias)	Unclear risk	Comment: no data
Other bias	Unclear risk	Comment: no data