Osborn 2010.

Methods	Randomised controlled clinical trial (RCT): 2 groups—intervention and control Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: Self‐identified Puerto Rican ethnicity Age 18 years or older Diagnosis of type 2 diabetes for > 1 year Exclusion criteria: None specifically stated Diagnostic criteria: not stated
Interventions	Number of study centres: 1 Treatment before study: not stated Intervention: a single 90‐minute session with a bilingual medical assistant of Puerto Rican heritage. Medical assistant received approx. 40 hours of training in diabetes self‐management before the session. Session was based on the Information‐Behavioural Skills (IMB) model of health behaviour change. Information/Education was provided with use of a flip chart and interactive discussion. Culturally appropriate foods were used as examples as to what can raise blood glucose. Motivational interviewing was carried out to try to enhance motivation—this involved personalised feedback on self‐care activities and open‐ended query and exploration of self‐care attitudes and beliefs. Behavioural skills were targeted and enforced using a teach‐back method to ensure understanding Each participant received a personal feedback report immediately after the session (contained self‐generated reasons to change, agreed on goals, etc.) and a culturally tailored, individualised meal plan booklet. This was intended to promote positive attitudes about adhering to diet recommendations and therefore enhance participants' motivation to change. Participants were also provided with 0‐3 handouts, depending on personal relevance as determined by the interventionist. Finally, all participants received a brochure of culturally familiar foods with recommended serving sizes No further support was offered post intervention Control: Participants in the control group received usual care. However, this included an optional diabetes support group coupled with group‐based didactic education delivered in Spanish. This support group was free, delivered on a monthly basis and facilitated by a bilingual diabetes community health worker of Puerto Rican heritage. This session was not tailored to the individual needs of the participant. Participants in the intervention arm could also attend this session Provider: intervention session provided by a bilingual medical assistant of Puerto Rican heritage
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Secondary outcome(s): Assessed at baseline and at 3 months: Food label reading—assessed using 4 items created that asked, "In the last 30 days how often did you: look at the serving size information on a food label, look at food labels to look at the total carbohydrate content, count carbohydrates and select foods that are low in carbohydrates." Response options ranged from 1 = never to 5 = always Diet adherence—assessed using the diet subscale of the Summary of Diabetes Self‐Care Activities questionnaire (SDSCA) Physical activity—assessed using the exercise subscale of the SDSCA HbA1c
Study details	Run‐in period: unclear Study terminated before regular end: no
Publication details	Language of publication: English Funding: grants and awards from Center for Health Intervention and Prevention (University of Connecticut), NIH/NIDDK National Research Service Award, Diversity Supplement Award, NIH/NCMHD Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To evaluate the effect of an IMB model of diabetes self‐care on Puerto Ricans with type 2 diabetes in terms of diet behaviour, physical activity and glycaemic control"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Patients were randomised" Comment: no information given as to how this was done
Allocation concealment (selection bias)	Unclear risk	Quote from publication: "Research assistants were blind to the random allocation sequence"
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: participants and personnel not blinded because of the nature of the intervention
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: participants and personnel not blinded because of the nature of the intervention
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: It is not commented upon whether or not they were blinded; unlikely to affect HbA1c however
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: self‐reported outcome measures at high risk of bias in an unblinded population
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: analysis by per‐protocol approach, not by intention‐to‐treat, but only ˜10% lost to follow‐up
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: analysis by per‐protocol approach, not by intention‐to‐treat, but only ˜10% lost to follow‐up
Selective reporting (reporting bias)	Unclear risk	Comment: All stated outcomes were reported but study protocol was not seen
Other bias	Unclear risk	Comment: none