D'Eramo Melkus 2010.

Methods	Randomised controlled clinical trial (RCT): 2 groups Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: African American women Age between 21 and 65 years Diagnosis of T2DM, confirmed by the C‐peptide assay BMI < 37 Diabetes treatment received from a primary care provider Ability to read and speak English Exclusion criteria: Required insulin Pregnant or lactating Diagnosed serious psychiatric or medical illness (cancer, AIDS) Diabetes‐related complications (renal disease)
Interventions	Number of study centres: 2 (primary care centre and adjacent school of nursing). Treatment before study: N/A Intervention: 11 weekly group sessions. The first 6 sessions (each 2 hours in duration) provided culturally relevant cognitive‐behavioural diabetes self‐management training. Each of the 6 sessions had a specific learner objective. Culturally specific materials were used for each session, with a focus on cultural barriers and beliefs that support or hinder healthy dietary intake. A culturally specific video and culturally relevant cookbooks were used The remaining 5 sessions comprised coping skills training (CST). These sessions were led by a clinical psychologist or a psychiatric mental health nurse trained in CST. These sessions addressed the following areas using the context of lifestyle behaviour for supporting T2DM self‐management: understanding stress, identifying and exploring problems, applying problem‐solving strategies, managing stress and communication Control: 10 weekly sessions of conventional diabetes education and group follow‐up question and answer sessions. Each group consisted of 8‐10 participants. Sessions 1‐5 provided culturally neutral, usual diabetes education; sessions 6‐10 provided diabetes discussion Provider: CST in intervention sessions led by a psychiatric mental health nurse
Outcomes	All physiological (excluding lipids) and self‐report measures (excluding demographic data) were collected at 3, 6, 9, 12 and 24 months. Fasting lipid levels repeated at 12 and 24 months HbA1c Blood pressure—systolic and diastolic Anxiety—measured using the Crown‐Crisp Index Diabetes‐related emotional distress—measured using the 25‐item Problem Areas in Diabetes Survey (PAID) Diabetes‐specific social support—measured using the subscale of the Diabetes Care Profile (DCP) Diabetes self‐efficacy—measured using the Diabetes Self‐Efficacy Outcomes Expectancies Questionnaire (DSEQ) Diabetes knowledge—assessed using a 25‐item self‐administered multiple‐choice objective test developed by D'Eramo‐Melkus et al General QoL—measured using Medical Outcomes Study Health care provider support—measured using the Modified Health Care Climate Questionnaire (MHCCQ)
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: NIH NIHR funding Publication status: peer review journal
Stated aim of study	"The purpose of this study was to evaluate the effectiveness of a tested (Melkus et al. 2004), culturally relevant primary care nurse‐led intervention of group DSMT, CST and diabetes care for black women with T2D"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "computer randomised"
Allocation concealment (selection bias)	Unclear risk	Comment: not commented upon
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: blinding of participants/personnel not commented upon. It is assumed that participants are not blinded, given the nature of the study
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: blinding of participants/personnel not commented upon. It is assumed that participants are not blinded, given the nature of the study
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: blinding of outcome assessors not commented upon. Blinding unlikely to affect blood results. However manual BP readings may be at risk
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: self‐reported subjective outcome scales at high risk of bias
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: data presented in the text different from data in Figure 2 labelled ITT. Therefore we can assume that data in the text (i.e. data included in this meta‐analysis) include the subgroup analysis, which does not include the ˜1/3 participants who dropped out. They are roughly equal in each arm, which is attributed to "work and/or family issues." Risk is therefore unclear
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: data presented in the text different from data in Figure 2 labelled ITT. Therefore we can assume that data in the text (i.e. data included in this meta‐analysis) include the subgroup analysis, which does not include the ˜1/3 participants who dropped out. They are roughly equal in each arm, which is attributed to "work and/or family issues." Risk is therefore unclear
Selective reporting (reporting bias)	Unclear risk	Comment: all stated outcomes reported but study protocol not seen
Other bias	Unclear risk	Comment: none