Kim 2009.

Study characteristics
Methods	Study design: RCT (pilot), 2 arms Geographic location: Baltimore‐Washington area, USA Ethical approval: yes Recruitment setting: Korean Resource Center (KRC), a community‐based site in partnership with the research team Method of recruitment: multiple sources (list of participants in the authors' previous studies, ethnic media (e.g. newspapers, radio stations), ethnic Korean churches, Korean grocery stores) Length of follow‐up: 30 weeks after randomisation (immediately after programme was completed) Dropouts: 4 lost to follow‐up at 6 months after baseline, 1 in the intervention group and 3 in the control group (reason: lack of time) A priori calculation of effect size/power?: yes
Participants	Description: Korean American immigrants with type 2 diabetes Health topic Type 2 diabetes Inclusion criteria Self‐identification as Korean American immigrant, age ≥ 30 years, self‐identification as having diabetes with an uncontrolled glucose level (A1C) ≥ 7.5% within the past 6 months, resident of the Baltimore‐Washington area, able to give written consent to participate in the intervention study Exclusion criteria Unable to give informed consent, physical or mental health conditions that could limit active participation in the study (e.g. blindness in both eyes, severe immobility, psychiatric diseases), haematological condition that would affect A1C assay, e.g. haemolytic anaemia, sickle cell anaemia Intervention group Self‐help intervention programme for type 2 diabetes management (SHIP‐DM) (41 randomised and 40 analysed) Control group Brief brochure and delayed intervention (42 randomised and 39 analysed) PROGRESS‐Plus Place of residence: urban, USA Time living in host country (years): 53.2% > 20 y Race/ethnicity: Korean Americans Occupation: 70.3% employed Gender: Intervention: 37.5% female Control: 51.3% female Education: 48.1% higher level of education Socioeconomic status/income (annual family income): 59.2% > USD 40,000 Social capital: 87.3% married Age (years), mean (SD): 56.4 (7.9) Health literacy (baseline) Not measured
Interventions	Intervention: SHIP‐DM Theoretical framework: theories of health literacy; PRECEDE–PROCEED model (Green 1991) Description: community‐based, multimodal behavioural SHIP‐DM that consisted of 3 main intervention modes: (1) 6 weeks of behavioural group education programmes related to diabetes mellitus, (2) home glucose monitoring with tele transmission (HGMT) and (3) individual counselling. The weekly educational group sessions included features to increase knowledge about diabetes, psychological education and health literacy education. Participants were provided with a glucose monitor, an electronic BP monitor and an HGMT‐system. Measurement data were transmitted and made accessible for nurse counsellors. Participants received monthly measurement reports through nurse counsellors. Monthly telephone counselling included data reviewing, reinforcement of lessons learned, discussion of issues related to diabetes self‐management, assistance and emotional support. Intervention provider: trained CHW and research nurses Delivery method/mode: 6 weekly face‐to‐face group sessions lasting 2 hours, followed by 6 months of self‐monitoring and monthly telephone counselling (10 to 25 min) Language of delivery: language concordant (bilingual) Format: tailored Setting/location: KRC, participants’ home Consumer involvement: culturally and linguistically informed through involvement of bilingual researchers, clinicians and members of the community of interest Comparator Type: written information on the same topic Description: control group participants received a standard brochure about diabetes and a delayed intervention.
Outcomes	Outcomes assessed in the study: diabetes knowledge, self‐efficacy, self‐care activities, depression, diabetes‐related quality of life, A1C level, fasting glucose, lipid batteries, blood pressure, height, weight (BMI), attitudes towards diabetes Outcomes considered in this review Health‐related knowledge (diabetes knowledge) Self‐efficacy (diabetes self‐efficacy) Health behaviour (diabetes self‐care activities) Health outcomes (depression) Quality of life (diabetes‐related quality of life) Methods of assessing outcomes All outcomes considered in this review were assessed with the use of structured questionnaires. Diabetes knowledge: Diabetes Knowledge Test (DKT), 2 components, (1) 14‐item general test, 0 to 14, higher score is better (2) 9‐item insulin‐use sub‐scale, higher score is better Language of assessment: Korean translation of validated tool Reliability/validity: validated within target population, Cronbach alpha for both components α ≥ 0.70 Diabetes self‐efficacy: adapted Stanford Chronic Disease Self‐Efficacy Scale, 8 items, 10‐point Likert scale, 1 = not confident at all, 4 = very confident, 0‐80, higher score is better Reliability/validity: validated within study sample, Cronbach alpha α = 0.85, test‐retest reliability = 0.80 Diabetes self‐care activities: Summary of Diabetes Self‐Care Activities (SDSCA), activities include dietary information, exercise, blood glucose testing, foot care and smoking, higher score is better Reliability/validity: average inter‐item correlations mean = 0.47, test‐retest correlations mean = 0.40, correlations with other criterion measures mean = 0.23 Note: psychometric properties were obtained from a review of 5 randomised interventions and 2 observational studies (combined sample of 1988 people with diabetes) (Toobert 2000). Depression: Kim Depression Scale for Korean Americans (KDSKA), 21 items divided into 4 sub‐scales (emotional, cognitive, behavioural and somatic); items are presented as declarative sentences related to 1 symptom of depression and a set of response options that measure frequency of depression symptoms in a 1‐week period, 0 to 75, lower score is better Translation procedure: validated Korean version Reliability/validity (N = 303): Cronbach alpha α = 0.93 Diabetes‐related quality of life: translated and culturally adapted version of the Diabetes Quality of Life Measure (DQOL), 46 items, 4 dimensions (worries about future effects of diabetes (1), worries about social and vocational issues (2), impact of treatment (3), personal satisfaction with treatment (4)), lower score is better Reliability/validity: Cronbach alpha α = 0.66 to 0.92, test‐retest reliability r = 0.78 to 0.92 Language of assessment: Korean Translation procedure: back‐translation procedure and panel consensus approach (applies to knowledge and self‐efficacy) Timing of outcome assessment: baseline, at 18 weeks and at 30 weeks after randomisation (short‐term). We report on the 30‐week assessment only as this is the earliest time point after the intervention programme was completed.
Health literacy	Definition: not reported Health literacy components addressed by the intervention Prerequisites and tools Knowledge Motivation Competences Steps of information processing Access Understand Appraise Apply Health domain: health care
Notes	Trial ID: NCT00505960 Funding: funding was provided by the National Institutes of Health (NIDDK R34 DK071957), LifeScan, Inc (HCC002154), and the Johns Hopkins University School of Medicine General Clinical Research Center (M01‐RR00052), from the National Center for Research Resources/National Institutes of Health. Additional notes: authors were contacted and asked for additional information (e.g. gender‐separate scores) but without success.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The 83 participants with confirmed eligibility were then randomly assigned to either the SHIP‐DM intervention group (n = 41) or the control (delayed intervention) group (n = 42) by computer‐automated random assignment."
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Because of the nature of this intervention and the design of the study, blinding of subjects to random assignment was not feasible." Non‐blinding might have affected the results of subjectively measured outcomes.
Blinding of outcome assessment (detection bias) subjective outcome measures	High risk	Personnel and participants were not blinded to study condition. Subjective outcomes were measured with repeated questionnaires.
Blinding of outcome assessment (detection bias) objective outcome measures	Low risk	Outcome assessors were not blinded but knowledge was objectively measured and not subjective to interpretation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"One participant from the intervention group and 3 from the control group withdrew because of a lack of time (retention rate = 95.2%). Outcome data are available for almost all participants indicating a low risk of bias.
Selective reporting (reporting bias)	Low risk	All outcomes reported in the methods are reported in the results section.