THIS DIET 2008.

Methods	RCT
Participants	People following a first MI (USA) CVD risk: high Intervention 1 low fat: 50 randomised, 50 analysed Intervention 2 modified fat: 51 randomised, 51 analysed Mean years in trial: 2 % male: low fat 68%, modified fat 80% Age, years: low fat 58 (sd 9), modified fat 58 (sd 10)
Interventions	Low fat vs modified fat Low fat aims: <30%E from fat, 7%E or less from SFA, 10‐15%E MUFA, 200mg/d or less cholesterol, 0.3 to 0.45%E from n‐3 Modified fat aims: 30‐40%E from fat, 7%E or less from SFA, 20‐25%E MUFA, 200mg/d or less cholesterol, >0.75%E from n‐3 Control methods: 6+ classes plus individual dietetic appointments (2 in first month, then at 3, 6, 12, 18 and 24 months) Intervention methods: 6+ classes plus individual dietetic appointments (2 in first month, then at 3, 6, 12, 18 and 24 months) Total fat intake (at 12 months): low fat 27.9 (sd 7.0), mod fat 30.1 (sd 8.6)%E Saturated fat intake (at 12 months): low fat 7.5 (sd 2.7), mod fat 7.9 (sd 3.4)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: mortality and morbidity Data available on total mortality? yes, none Cardiovascular mortality? yes, none Events available for combined cardiovascular events: MI, unstable angina, stroke Secondary outcomes: cancer deaths (none), stroke, total and non‐fatal MI Tertiary outcomes: HDL and LDL cholesterol, TG, BMI, BP
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sealed envelopes, stratified by diabetes, 10 envelope blocks, selected in prepared order from locked drawer by study dietitian.
Allocation concealment (selection bias)	Low risk
Blinding (performance bias and detection bias) All outcomes	High risk	Participants were aware of allocation as taught the diet.
Incomplete outcome data (attrition bias) All outcomes	Low risk	For primary outcomes
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?	Low risk	Same number of individual dietetic appointments and group sessions in both arms. 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	Smoking cessation, weight loss and exercise encouraged in both arms.