Moy 2001.

Study characteristics
Methods	RCT Summary risk of bias: moderate to high
Participants	Middle‐aged siblings of people with early CHD, with at least 1 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) Ethnicity: African‐American 18% int, 25% control (remainder of group ethnicity not described, and outcomes not presented by ethnicity) Statins use allowed? Unclear (raised LDL cholesterol was a condition of entry, so use of statins probably minimal) % taking statins: Not reported
Interventions	Reduced fat intake vs usual diet Control aim: usual care Intervention aim: total fat 40 g/d or less Control methods: usual physician care with risk factor management at 0, 1 and 2 years Intervention methods: Individualised counselling by trained nurse, appointments 6 ‐ 8 weekly for 2 years Intervention delivered individually, face‐to‐face by a trained nurse. Total fat intake, %E (at 2 years): int 34.1 (SD unclear), cont 38.0 (SD unclear) (mean difference ‐3.90, 95% CI ‐6.46 to ‐1.34 assuming SDs of 10) significant reduction Saturated fat intake, %E (at 2 years): int 11.5 (SD unclear), cont 14.4 (SD unclear) (mean difference ‐2.90, 95% CI ‐4.18 to ‐1.62 assuming SDs of 5) significant reduction PUFA intake: not reported PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported MUFA intake: not reported CHO intake: not reported Protein intake: not reported Trans fat intake: not reported Replacement for saturated fat: unclear 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, CHD mortality (none), CHD events (MI or angina) Tertiary outcomes: BMI, HDL and LDL cholesterol, TG
Notes	Study duration 2 years Study aim was to reduce total fat based on ATPII dietary guidelines, and preliminary work established that this intervention reduced saturated fat and dietary cholesterol, and saturated fat intake was significantly lower than in the control group SFA reduction aimed and achieved Total serum cholesterol not reported, but LDL was, difference between intervention and control, mmol/L: ‐0.29 (95% CI ‐0.54 to ‐0.04), statistically significant reduction Trial dates: Study recruitment 1991 to 1994 Funding: National Institute of Nursing Research, General Clinical Research Center of the National Institutes of Health Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions
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	Allocation method not clearly described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants clear about their allocation
Blinding of outcome assessment (detection bias) CVD outcomes	High risk	Trialists clear about allocation
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Blinding is not relevant in assessment of mortality.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear, deaths, cancer and CV events are dropouts, trialists were 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
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
Stated aim to reduce SFA	Low risk	Aim to reduce SFA stated
Achieved SFA reduction	Low risk	SFA reduction achieved
Achieved TC reduction	Low risk	Statistically significant LDL fall (though TC not reported)
Other bias	Low risk	None noted