Toobert 2011.

Methods	Randomised controlled clinical trial (RCT): 2 groups: intervention and control Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: Self‐identified Latina ethnicity 30‐75 years of age Diagnosis of type 2 diabetes for at least 6 months, identified by electronic medical record codes and using the Welborn criteria Living independently Having a telephone Ability to read in either English or Spanish Not developmentally disabled Living close enough to the intervention site to attend weekly meetings Exclusion criteria: On an insulin pump Having end‐stage renal disease Participating population: Latina women diagnosed with type 2 diabetes living in Denver, Colorado
Interventions	Number of study centres: recruited from 9 Kaiser Permanente clinics in Denver area and 1 community health centre, the Salud Family Health Center, located in Commerce City (near Denver) Treatment before study: not stated Intervention: Intervention was the Viva Bien programme, a culturally adapted version of the previously established Mediterranean Lifestyle Program for diabetes. The intervention involved a 2.5‐day retreat, followed by 4‐hour weekly meetings for 6 months, then fortnightly meetings for the remaining 6 months The purpose of the retreat was to introduce each of the major components of the programme and provide time for participants to practice new skills. The 4‐hour meetings included an hour of instruction on the following topics: diet, stress management, physical activity and support groups The intervention was culturally adapted by using information gathered from a literature review and focus groups. Examples of changes made include greater family involvement, foods common in Latin American countries that could be used in modified Mediterranean diet recipes and incorporation of Latin music, language and symbols in meetings and materials Control: Control group received usual care only. No details given as to what this involves Provider: retreat led by "bilingual staff" Not stated who ran meetings ("facilitator led"). Sounds as though a team of bilingual staff ran the meetings, probably including a nurse and a dietician
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Secondary outcome(s): Outcomes assessed at 6 and 12 months: Problem‐solving ability (assessed using the Diabetes Problem‐Solving Interview) Self‐efficacy (assessed using the Confidence in Overcoming Challenges to Self‐Care Instrument) Social support (assessed using the UCLA Social Support Inventory) % of calories from saturated fat (assessed using the Food Frequency Questionnaire developed at the Fred Hutchinson Cancer Research Center) Stress management practice (assessed through self‐report log, which recorded daily minutes of yoga stretches, breathing exercises, progressive relaxation, etc) Number of days per week participants engaged in physical activity (assessed using the Modified International Physical Activity Questionnaire) Individual's support for behaviour‐specific disease management (assessed using the Brief Chronic Illness Survey) Engagement in social‐environmental support activities (assessed using the Chronic Illness Resources Survey score) HbA1c Health‐related quality of life (assessed using the CDC Healthy Days measure) Ten‐year heart disease risk (assessed using the United Kingdom Prospective Diabetes Study logistic equation) Smoking prevalence (participants were asked if they had smoked a cigarette in the past 7 days)
Study details	Run‐in period: unclear Study terminated before regular end (for benefit/because of adverse events): no
Publication details	Language of publication: English Funding: National Heart, Lung and Blood Institute Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "The purpose of this paper was to document the extent to which the Viva Bien intervention helped Latinas with type 2 diabetes to make simultaneous changes in psychosocial factors and multiple lifestyle behaviours that were hypothesised to result in improved biologic and quality of life outcomes at 6 and 12 months"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: randomisation done through a "computerized random number generator"
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: assessors blinded to the assignment at baseline assessment only. After that, they were aware of participant treatment assignments
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: assessors blinded to the assignment at baseline assessment only. After that, they were aware of participant treatment assignments
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: HbA1c assessment unlikely to have been affected by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Quote from publication: "Much of the assessment did not involve assessors, and therefore could not be biased by their knowledge of treatment assignment" Comment: however, participants completing questionnaires not blinded
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	Comment: Both ITT and per‐protocol analyses were carried out, with similar results and ITT data reported
Incomplete outcome data (attrition bias) Subjective outcomes	Low risk	Comment: Both ITT and per‐protocol analysis were carried out, with similar results and ITT data reported
Selective reporting (reporting bias)	Unclear risk	Comment: Results are given for all stated outcomes; study protocol not seen
Other bias	Unclear risk	Comment: none