Methods	RCT
Participants	Post-menopausal women aged 50-79 with CVD at baseline (USA) CVD risk: high Control: randomised 1369, analysed 1369 Intervention: randomised 908, analysed 908 Mean years in trial: control 8.1, intervention 8.1 % male: 0 Age: mean (women both with and without CVD at baseline) int 62.3 (sd 6.9), control 62.3 (sd 6.9)
Interventions	Reduced fat vs. usual diet Control: diet-related education materials Intervention: low fat diet (20% E from fat) with increased fruit and vegetables Control methods: given copy of‘Dietary Guidelines for Americans’ Intervention methods: 18 group sessions with trained and certified nutritionists in the first year, quarterly maintenance sessions thereafter, focusing on diet and behaviour modification Total fat intake (at 6 years): int 28.8 (sd 8.4)%E, cont 37.0 (sd 7.3)%E Saturated fat intake (at 6 years): int 9.5 (sd 3.2)%E, cont 12.4 (sd 3.1)%E Style: dietary advice Setting: community
Outcomes	Stated trial outcomes: breast cancer, mortality, other cancers, cardiovascular events, diabetes Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: CHD, stroke, heart failure, angina, peripheral vascular disease, revascularization, pulmonary embolism, DVT Secondary outcomes: cancer deaths*, cancer diagnoses*, stroke, non-fatal MI Tertiary outcomes: weight, BMI, total, LDL and HDL cholesterol, TGs, systolic and diastolic BP * these are only available for the whole cohort, not split between low and high CVD risk groups
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer algorithm
Allocation concealment (selection bias)	Low risk
Blinding (performance bias and detection bias) All outcomes	High risk	Participants aware of allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
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	Intervention participants received 18 group sessions with behavioural modification plus quarterly maintenance sessions thereafter, control groups received a leaflet. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat?	High risk	Also fruit and vegetable intervention. See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies