Rosal 2005.

Methods	Parallel randomised controlled clinical trial (RCT) (pilot) Randomisation ratio: assumed 3:2 Superiority design
Participants	Inclusion criteria: Being registered with a healthcare provider Having a doctor‐confirmed diagnosis of type 2 DM > 18 years of age Home phone Doctor's approval to participate in PA of the intervention Ability to provide informed consent in English or Spanish Exclusion criteria: History of diabetes ketoacidosis Current gestational diabetes Planning to move out of the area during study period Steroid use during previous year Having had a CV (cardiovascular) event in previous 6 months Diagnostic criteria: not stated Participating population: individuals (in a community with 80% Puerto Rican heritage) with type 2 DM > 18 years of age
Interventions	Number of study centres: 1 community health centre, an affiliated elder health centre and a community‐wide database Treatment before study: not stated Number of study centres: not stated Intervention: consisted of an initial 1‐hour individual session, followed by 2 3‐hour weekly group sessions for 10 weeks and 2 15‐minute sessions. individual sessions during the 10‐week period. Primary care physicians received copies of laboratory results at each assessment point Control: Usual care and primary care physicians received copies of laboratory results as intervention group did Provider: bilingual nutritionist, diabetes nurse and assistant
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Feasibility (rates of attendance, recruitment and assessment) HbA1c Lipid profile BP Height Weight Hip/waist ratio Behavioural: 2 unannounced 24‐hour dietary recalls; modified version of Community Healthy Activities Model Program for Seniors PA questionnaire 24‐Hour SMBG recall Adapted from "Audit of Diabetes Knowledge" Audit of Diabetes Quality of Life Insulin Management Self‐Efficacy Scale Center for Epidemiological Studies–Depression Scale Secondary outcome(s): Not specified between primary and secondary outcomes
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: American Diabetes Association Innovation Award, which in part is supported by NovoNordisk Pharmaceuticals Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To assess the feasibility of an innovative self‐management education in low income Spanish speaking individuals and secondly to have a preliminary data of intervention effects"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: method of randomisation not specified
Allocation concealment (selection bias)	Unclear risk	Quote from publication: "Research assistants administered informed consent documents ... and were blind to the random sequence allocation" Comment: does not specify method of allocation concealment
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: providers not blinded because of the nature of the intervention; participants unlikely to have been blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: providers not blinded because of the nature of the intervention; participants unlikely to have been blinded
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: does not say whether research assistants taking blood pressure were blinded. However, details given for standardised procedure for doing this
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants completing questionnaires unlikely to have been blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: does not mention whether any participants were lost to follow‐up; no numbers in results and no mention of whether ITT analysis was used
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: does not mention whether any participants were lost to follow‐up; no numbers in results and no mention of whether ITT analysis was used
Selective reporting (reporting bias)	Unclear risk	Comment: no outcomes appear unreported but protocol not seen
Other bias	Unclear risk	Comment: none