Rosal 2011.

Methods	Parallel randomised controlled clinical trial (RCT): 2 groups—control and intervention Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: Latino ethnicity Age 18 years or older Last HbA1c was > 7.5% Ability to walk Ability and willingness to provide informed consent (in English or Spanish) Physician approval to participate Exclusion criteria: Type 1 diabetes or ketoacidosis Medical contraindications to participation Use of glucocorticoid therapy within the prior 3 months Currently participating in a cardiac rehabilitation or formal weight loss programme Plans to move out of the area within the 12‐month study period Participating population: Latino patients diagnosed with type 2 diabetes
Interventions	Number of study centres: 5 community health centres Treatment before study: not stated Intervention: 'Latinos en Control' intervention consisted of an intensive phase of 12 weekly sessions and a follow‐up phase of 8 monthly sessions. Social‐cognitive theory was used as a framework to targeted previously identified needs in this population: diabetes knowledge, attitudes and self‐management behaviours. Sessions were made literacy and culturally appropriate by simplifying concepts, using an educational soap opera (soap operas popular in this population), putting desired behaviours into culturally relevant context, using bingo games and emphasising making traditional foods healthier and other things Group sessions were 2.5 hours long, with the 1st hour covering personalised counselling and cooking and the remaining time covering the group protocol and a meal Control: Participants in the control group received no intervention. All primary care providers received laboratory results (HbA1c, lipid profiles, FBG) at baseline and at 4 and 12 months, and were free to provide care as deemed appropriate or as routinely delivered Provider: Intervention was delivered by a trained team of 2 leaders and an assistant (a nutritionist or a health educator and trained lay individuals, or 3 lay individuals supervised by 2 investigators)
Outcomes	Assessed at baseline, at 4 months (post intensive intervention) and at 12 months (end of proper intervention) Primary outcome HbA1c Secondary outcomes Blood pressure BMI Lipid profile Medication intensity—assessed using a medication intensity variable, constructed by assigning a low score for regimens based on monotherapy with oral agents and increasing the score as the number of oral agents increased Dietary intake Physical activity Blood glucose self‐monitoring (last 3 items listed here were all assessed using 24‐hour recall, as a dietician made an unannounced telephone call to obtain the recalls Diabetes knowledge—measured using a subset of items from the Audit of Diabetes Knowledge
Study details	Run‐in period: none Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases Grant Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To test whether a theory‐based, literacy and culturally tailored self‐management intervention, Latinos en Control, improves glycaemic control among low‐income Latinos with type 2 diabetes"
Notes	Study author provided extra details on results data for BP and lipids
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "A stratified randomisation scheme was created using Stata's ralloc procedure" "Patients from the same family were assigned to the same study condition"
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Quote from publication: "Due to nature of assignment, we could not blind participants PCPs" Comment: participants unlikely to have been blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote from publication: "Due to nature of assignment, we could not blind participants PCPs" Comment: participants unlikely to have been blinded
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Quote from publication: "Trained bilingual and bicultural research staff blinded to the study condition conducted assessments"
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants not blinded
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	Comment: intention‐to‐treat analysis used (all 252 participants randomly assigned were included in analysis)
Incomplete outcome data (attrition bias) Subjective outcomes	Low risk	Comment: intention‐to‐treat analysis used (all 252 participants randomly assigned were included in analysis)
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen, and several secondary outcomes from abstract not reported
Other bias	Low risk	Comment: none