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 |
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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 |
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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. |