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. 2012 May 16;2012(5):CD002137. doi: 10.1002/14651858.CD002137.pub3

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
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
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