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

McAuley 2005.

Methods RCT
Participants Overweight and insulin‐resistant women (New Zealand)
 CVD risk: low
 Low fat: randomised 32, analysed 24 (at 1 year)
 Modified fat: randomised 30, analysed 28 (at 1 year)
 Mean years in trial: low fat 0.88, modified fat 0.97
 % male: 0
 Age: mean low fat 45 (sd 7.5), modified fat 47 (sd 7.9)
Interventions Reduced fat vs Modified fat diet
Modified fat aims: 30%E from fat, predominantly MUFA, protein 30%E, CHO low glycaemic index 40%E, 5 meals/d, less than 5 hours between meals, ad libitum consumption, 30mins activity 5 days/week advised
 Low fat aims: total fat <30%E, SFA <8%, protein 15%E, CHO >55%E, advised to reduce dietary fat, salt and sugar, national healthy eating guidelines plus at least 6 servings of bread and whole‐grains /d, at least 3 of vegetables, 2 of fruit, 2 of low fat dairy/d, ad libitum consumption, 30mins activity 5 days/week advised
(Also a high fat Atkins‐type arm)
Low fat methods: unclear how much dietary advice, or who delivered
Modified fat methods: unclear how much dietary advice or who delivered it
Total fat intake (at 6 months): low fat 28 (sd 7)%E, mod fat 35 (sd 7)%E
Saturated fat intake (at 6 months): low fat 10 (sd 4)%E, mod fat 11 (sd 3)%E
Style: diet advice
Setting: community
Outcomes Stated trial outcomes: weight loss, lipids
 Data available on total mortality? yes (none)
 Cardiovascular mortality? yes (none)
 Events available for combined cardiovascular events: total MI, stroke (no CVD events)
Secondary outcomes: non‐fatal and total MI, stroke, cancer deaths and diagnoses (no events for any outcome)
Tertiary outcomes: weight, BMI, total, LDL and HDL cholesterol, TG, systolic and diastolic BP
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'randomised'
Allocation concealment (selection bias) Unclear risk Randomisation method not clearly described
Blinding (performance bias and detection bias) 
 All outcomes High risk Participants knew allocation, unclear whether researchers did also
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? Unclear risk Probably, as both groups were taught their diets. 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 Differences in meal frequency, salt and sugar advice.