Methods	RCT
Participants	Men recovering from an MI (UK) CVD risk: high Control: randomised 1015, analysed unclear Intervention: randomised 1018, analysed unclear Mean years in trial: control 1.9, randomised 1.9 % male: 100% Age: mean control 56.8, intervention 56.4 (all <70)
Interventions	Reduced and modified fat vs usual diet Control aims: no dietary advice on fat, weight reducing advice if BMI>30 Intervention aims: reduce fat intake to 30%E, increase P/S to 1.0, weight reducing advice if BMI>30 Note: This was a factorial trial, and so some in each group were randomised to increased fatty fish and/or increased cereal fibre Control methods: dietitians provided ‘sensible eating’ advice without specific information on fats Intervention methods: dietitians provided the participants and their wives with initial individual advice and a diet information sheet, participants were revisited for further advice, recipes, encouragement at 1, 3, 6, 9, 12, 15, 18 and 21 months Total fat intake (through study): int 31 (sd 7), cont 35 (sd 6)%E Saturated fat intake (through study): int 11 (sd 3), cont 15 (sd 3)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: mortality, reinfarction Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: cardiovascular deaths (including stroke deaths) plus non-fatal MI Secondary outcomes: cancer deaths, total MI, non-fatal MI Tertiary outcomes: total and HDL cholesterol
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	randomised using sealed envelopes
Allocation concealment (selection bias)	Unclear risk	Unclear if envelopes were opaque
Blinding (performance bias and detection bias) All outcomes	High risk	Physician blinding: yes Participant blinding: unclear
Incomplete outcome data (attrition bias) All outcomes	Low risk	GPs contacted for information on mortality and morbidity when patients did not attend
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	Different levels of advice appear to have been provided. 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	There were also other arms, testing fish and fibre interventions (in a factorial design). See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies