Franz 1995.
| Study characteristics | ||
| Methods |
Effectiveness of medical nutrition therapy provided by dietitians in the management of non‐insulin‐dependent diabetes mellitus: a randomized, controlled clinical trial Patient RCT, conducted in diabetes centres in Minnesota, Florida, and Colorado, USA Two arms: 1. BC Group ‐ basic nutrition care (control arm) and 2. PGC group ‐ practice guidelines nutrition care (intervention arm) |
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| Participants | Control arm N: 85 Intervention arm N: 94 Diabetes type: type 2 Mean age: 56.4 ± 7.8 % Male: 44.1 Longest follow‐up: 6 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Team changes 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.3 (1.9), post 7.6 (1.7) Intervention arm: pre 8.3 (1.8), post 7.4 (1.3) 2) LDL, mean mg/dL (SD) Control arm: pre 135.4 (38.7), post 135.7 (44.5) Intervention arm: pre 129.2 (38.7), post 125.7 (30.2) |
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| Funding source | This research was funded by The American Dietetic Association | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information not available. |
| Allocation concealment (selection bias) | Unclear risk | Information not available. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | Unclear risk | They do not report the numbers of dropouts by group, so unclear risk. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Information not available. |
| Selective reporting (reporting bias) | Low risk | Information not available. |
| Risk of contamination (other bias) | Unclear risk | The doctors were aware of the allocation and could have treated the dietician group differently. Also, the control group did see the dietician once and this could have made a huge impact on the control group. |
| Other bias | Low risk | Information not available. |