Moy 2001.
Methods | RCT | |
Participants | Middle‐aged siblings of people with early CHD, with at least one CVD risk factor (USA) CVD risk: moderate Control: randomised 132, analysed 118 Intervention: randomised 135, analysed 117 Mean years in trial: 1.9 % male: control 49%, intervention 55% Age: control mean 45.7 (sd 7), intervention 46.2 (sd 7) | |
Interventions | Reduced fat intake vs. usual diet Control: physician management (physicians informed on risk factor management). Intervention: nurse management, aim total fat 40g/d or less Control methods: physician management with risk factor management at 0, 1 and 2 years Intervention methods: nurse management, appointments 6‐8 weekly for 2 years Total fat intake (at 2 years): low fat 34.1 (sd unclear), cont 38.0 (sd unclear)%E Saturated fat intake (at 2 years): low fat 11.5 (sd unclear), cont 14.4 (sd unclear)%E Style: diet advice Setting: community |
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Outcomes | Stated trial outcomes: dietary intake
Data available on total mortality? yes, no deaths
Cardiovascular mortality? yes, no deaths
Events available for combined cardiovascular events: total MI, stroke, unstable angina, PVD and PTCA Secondary outcomes: cancer diagnoses (no events), cancer deaths (none), stroke, total and non‐fatal MI Tertiary outcomes: BMI, HDL and LDL cholesterol, TG |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned via computerised schema after all eligible siblings from a family had been screened |
Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants and trialists clear about their allocation |
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? | High risk | Differences in frequency of follow up, but unclear what differences in care occurred between the physician and nurse‐led care. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies |
Free of dietary differences other than fat? | Unclear risk | See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies |