De Greef 2011.
| Study characteristics | ||
| Methods |
Increasing physical activity in Belgian type 2 diabetes patients: a three arm randomized controlled trial Patient RCT, conducted in 3 Belgian general practices, Belgium Three arms: 1. Control group (control arm), 2. Group counselling (intervention arm 1) and 3. Individual consultation (intervention arm 2) |
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| Participants | Control arm N: 24 Intervention arm 1 N: 21 Intervention arm 2 N: 22 Diabetes type: type 2 Mean age: 67.4 ± 9.3 % Male: 70.0 Longest follow‐up: 3 months |
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| Interventions |
Control arm: None Intervention arm 1: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management Intervention arm 2: 1) Facilitated relay of clinical information 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.0 (0.9), post 6.9 (0.8) Intervention arm 1: pre 7.1 (1.4), post 6.9 (1.2) Intervention arm 2: pre 7.2 (0.7), post 6.9 (0.6) |
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| Funding source | NA | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…via computerized random numbers." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was concealed in sealed enveloped until the point of allocation…". Opaque envelopes? |
| Patient's baseline characteristics (selection bias) | High risk | BMI (P ≤ 0.05), waist circumference (P ≤ 0.01), DBP (P ≤ 0.05). |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up was < 10%, all for medical reasons. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | General practitioners were the ones who collected outcome data and they were not blinded to allocation of treatment arms. HbA1c: Adams haemoglobin A1c procedure. |
| Selective reporting (reporting bias) | High risk | Did not assess SBP, DBP (as stated in protocol) and various other outcomes including DEXA (Dual‐Energy X‐ray Absorptiometry) scan. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |