Baradaran 2006.
| Methods |
Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 1:1 South Asians plus white comparison control group approx 2:1 Superiority design |
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| Participants |
Inclusion criteria:
Exclusion criteria: not stated Diagnostic criteria: not specified |
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| Interventions |
Number of study centres: 3 general practices; 1 day care centre (originally 2 but 1 closed while the study was ongoing) Treatment before study: not stated if previous HE Intervention: 3 group sessions (1‐hour dietician‐led session and 1 hour and a half podiatrist‐led session) in 3 months. The intervention had a didactic component and an interactive group discussion component |
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| Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s): Changes in scores (from baseline to post intervention) for the following variables:
Secondary outcome(s): Differences in changes in score in above variables (4) |
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| Study details |
Run‐in period: not stated Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: funded in part by Iran University of Medical Sciences Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To develop a culturally appropriate educational intervention programme for South Asians with type 2 DM, and to assess if the intervention would improve knowledge, attitudes and practice of diabetes" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "The South Asian group was divided by gender, then each stratum was further divided based on their reading ability in any language.." Comment: not mentioned how randomly assigned to intervention/control |
| Allocation concealment (selection bias) | Unclear risk | Comment: not stated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Comment: no objective outcomes in study |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: unlikely because of the nature of the intervention |
| Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Unclear risk | Comment: no objective outcomes |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: not blinded because of the nature of the study |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: no objective outcomes |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: analysis of those lost to follow‐up looking at their baseline data and comparability. Roughly equal control and intervention group dropout rates, similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Unclear risk | Comment: no study protocol seen |
| Other bias | Unclear risk | Comment: none |