Anderson‐Loftin 2005.
Study characteristics | ||
Methods |
Soul food light: culturally competent diabetes education RCT (NA clusters and NA providers), conducted in 1) conducted at a diabetes education centre in a rural SC county 2) Educational classes were taught by a local registered dietician with experience in nutrition therapy for rural black southerners with diabetes. Peer‐professional discussion groups began 1 month after educational classes and were facilitated by a nurse case manager who was certified as a diabetes educator in United States of America 2 arms: 1) Control (usual care) (control arm) and 2) Intervention (dietary self‐management behavioural intervention) (intervention arm) |
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Participants | Control arm N: 48 Intervention arm N: 49, NA, NA Diabetes type: 2 Mean age: 57.32 ± 10.62 % Male: 21.65 Longest follow‐up: 12 months |
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Interventions |
Control arm: (usual care) 1) Patient education Intervention arm: (dietary self‐management behavioural intervention) 1) Case management 2) Patient education |
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Outcomes | 1) Glycated haemoglobin | |
Funding source | This study was funded by the National Institute of Nursing Research (1R15NR/DK07651‐01) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly assigned to experimental or control groups by the principal investigator based on a computer‐generated table of random numbers. |
Allocation concealment (selection bias) | Low risk | The RA who assigned participants identification numbers was blinded to group assignment. |
Patient's baseline characteristics (selection bias) | High risk | Quote: "Significant differences in duration of diabetes were found between groups at baseline (Table 1). Gender and 3 categories of medication (oral hypoglycaemic agents, insulin, and lipid‐reducing medications) were significant for at least 1 dependent variable. " |
Patient's baseline outcomes (selection bias) | High risk | See Table 1, differences between groups for HbA1c, LDL, triglycerides. |
Incomplete outcome data (attrition bias) | High risk | Retention in the experimental group was 78% and 56% in the control group; 32 participants (33%) were lost to attrition. Significant differences (P = 0.03) in attrition between experimental and control groups were observed. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure for HbA1c. |
Selective reporting (reporting bias) | Unclear risk | No protocol registered. Methods match outcomes. |
Risk of contamination (other bias) | Unclear risk | Patient randomised. Interaction between groups may have occurred. |
Other bias | Low risk | None identified. |