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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD002137. doi: 10.1002/14651858.CD002137.pub2
Methods RCT
Participants Healthy women, BMI >25 (UK)
CVD risk: low
Control: randomised 53, analysed 40
Intervention: randomised 57, analysed 42
Mean years in trial: control 0.42, intervention 0.43
% male: 0
Age: mean control 50, intervention 51
Interventions Reduced fat vs usual diet
Control aims: advice - total fat 35%E, CHO 34.5%E, 1200kcal per day encouraged but not prescribed
Intervention aims: total fat 20%E, CHO 58%E, 1200kcal/day encouraged but not prescribed
Control methods: dietary advice supported by exchanges and recipes
Intervention methods: dietary advice supported by exchanges and recipes
Total fat intake: unclear
Saturated fat intake: unclear
Style: diet advice
Setting: community
Outcomes Stated trial outcomes: weight loss and cardiovascular risk factors
Data available on total mortality? yes (no events)
Cardiovascular mortality? yes (no events)
Events available for combined cardiovascular events: cardiovascular deaths, non fatal MI, stroke (no events)
Secondary outcomes: total and non-fatal MI, stroke, cancer deaths (no events)
Tertiary outcomes: BMI, total, LDL and HDL cholesterol, TG, BP
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk “medical officer drew coloured straws from a box”
Allocation concealment (selection bias) Unclear risk Randomisation method not clearly described
Blinding (performance bias and detection bias)
All outcomes
High risk Participants were not blinded, unclear about researchers
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk Deaths, cancer and CV events are drop-outs, trialists asked for data
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 Similar intervention in both groups. 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 See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies