Van Dyck 2013.
| Study characteristics | ||
| Methods |
The relationship between changes in steps/day and health outcomes after a pedometer‐based physical activity intervention with telephone support in type 2 diabetes patients Patient RCT, conducted in endocrinology department of the Ghent University Hospital, Belgium Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
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| Participants | Control arm N: 32 Intervention arm N: 60 Diabetes type: type 2 Mean age: 62.0 ± 9.0 % Male: 69.0 Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.3 (0.9), post 7.6 (1.5) Intervention arm: pre 7.3 (0.9), post 7.3 (0.9) 2) SBP, mean mmHg (SD) Control arm: pre 129.7 (15.5), post 133.8 (23.6) Intervention arm: pre 133.7 (15.3), post 132.6 (15.7) 3) LDL, mean mg/dL (SD) Control arm: pre 89.7 (28.2), post 89.3 (32.9) Intervention arm: pre 84.7 (24.4), post 81.2 (27.5) |
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| Funding source | This research was supported by Fund for Scientific Research Flanders (FWO) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Table and text. |
| Patient's baseline outcomes (selection bias) | Low risk | In table and text. |
| Incomplete outcome data (attrition bias) | Unclear risk | 2 lost to follow‐up in each arm, but reasons not provided. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: SBP using Omron M6 in seated position after 5 minutes of resting, routinely calibrated, HbA1c using the Adams Hemoglobin A1c procedure, LDL using enzymatic colorimetric analysis. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; method match outcomes. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |