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 |
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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 |
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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 |
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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 |