Gucciardi 2007.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: randomly assigned—41 intervention:46 control Superiority design
Participants	Inclusion criteria:: Diagnosis of type 2 DM Speaking Portuguese Willingness to participate and to be randomly assigned Exclusion criteria: Renal dialysis Prior attendance at a similar HE programme Diagnosis of mental illness Diagnostic criteria: not stated
Interventions	Number of study centres: 1 Treatment before study: Individuals participating in previous health education were excluded Intervention: group + individual: 3 group meetings of 7 hours and individual meetings of 1 initial assessment + mean no. of visit 2.08 (0.95) Individual: 1 initial assessment + mean no. of visits 1.83 (0.69) Control: no control group Provider: individual + group: nurse, dietician, pharmacist, psychologist and physiotherapist. Nurse and dietician were also involved in the individual component of the intervention Individual: nurse and dietician
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): TPB scales: Attitudes Participants' norms PBC (perceived behaviour control) and intention towards nutrition adherence Adherence to nutrition management (summary of diabetes self‐care activities questionnaire) Glycaemic control HbA1c Secondary outcome(s): Not specified between primary and secondary outcomes
Study details	Run‐in period: not explicitly stated, possibly 3 months. Recruitment of participants took place between November 2001 and 2003 Study terminated before regular end: no
Publication details	Language of publication: English Funding: Banting and Best Diabetes Centre Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To examine the impact on nutrition adherence and glycaemic control of two culturally competent interventions (individual counselling vs. individual counselling and group education in Portuguese Canadian"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: participants randomly assigned using a generated random number list
Allocation concealment (selection bias)	Unclear risk	Comment: subjects randomised on the spot
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Comment: diabetes education (DEC) providers blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Comment: diabetes education (DEC) providers blinded
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: research assistants blinded to participant status
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Comment: research assistants blinded to participant status
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Comment: no intention‐to‐treat analysis
Incomplete outcome data (attrition bias) Subjective outcomes	High risk	Comment: no intention‐to‐treat analysis
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none