CARMEN MS sub‐study 2002.
| Methods | RCT (data for this study excludes the 13 participants that were included in the main CARMEN data set) | |
| Participants | People with at least 3 risk factors for metabolic syndrome (Europe, 5 centres)
CVD risk: moderate Control: 12 randomised, 8 analysed Intervention with simple CHO: 10 randomised, 9 analysed Intervention with complex CHO: 11 randomised, 9 analysed Mean years in trial: control 0.4, simple CHO 0.5, complex CHO 0.5 % male: control 0%, simple CHO 33%, complex CHO 22% Age: mean control 47.5 (sd 3.9), simple CHO intervention 44.7 (sd 4.7), complex CHO intervention 43.4 (sd 4.5) |
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| Interventions | Reduced fat vs usual diet Control aims: to attain national "normal" intake Intervention aims: total fat reduced by 10%E with increases in simple or complex CHO Control methods: trial shop provided local selection of a specific set of national "normal" intake foods Intervention methods: trial shop provided local selection of a specific set of low fat and high simple or complex CHO foods Total fat intake (at 6 months): low fat complex CHO 27.1 (sd 4.8), low fat simple CHO 20.6 (sd 6.6), cont 30.4 (sd 2.3)%E Saturated fat intake: unclear Style: food provided Setting: community |
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| Outcomes | Stated trial outcomes: weight, body composition, lipids Data available on total mortality? yes (no events) Cardiovascular mortality? yes (no events) Events available for combined cardiovascular events: CVD deaths, non‐fatal MI, stroke, heart failure, PVD (no events) Secondary outcomes: cancer deaths and diagnoses (no events) Tertiary outcomes: BMI, total, LDL and HDL cholesterol, TGs, diastolic BP |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomisation |
| Allocation concealment (selection bias) | Low risk | Randomisation by 3rd party, independent of research centres. Blind data were sent to him for computer randomisation |
| Blinding (performance bias and detection bias) All outcomes | High risk | Participants were clear about whether they were in the control or an intervention group |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear, deaths, cancer and CV events are drop‐outs, trialists asked for data ‐ unclear if any data missing |
| Selective reporting (reporting bias) | Low risk | Not relevant for primary and secondary outcomes as all trialists asked for data |
| Other bias | Low risk | |
| Free of systematic difference in care? | Low risk | Trial shop used by both groups. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies |
| Free of dietary differences other than fat? | Low risk | See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies |