Due Mod fat 2008.
| Methods | RCT | |
| Participants | Young overweight adults who had lost at least 8% of body weight (Denmark)
CVD risk: low
control: 25 randomised, 25 analysed (24 completed)
Intervention modified fat: 52 randomised, 52 analysed (39 completed) Mean years in trial: control 0.49, moderate fat 0.44 % male: control 42%, modified fat 41% Age: control group 27.6 (sd 5.1), modified fat 29.2 (sd 4.5) Baseline total fat intake: int cont Baseline saturated fat intake: int cont |
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| Interventions | Modified fat vs usual diet Control aims: 30‐40%E from fat, SFA >15%E, MUFA 5‐15%E, PUFA 0‐10%E, protein 10‐20%E, CHO 45‐55%E, added sugars 5‐15%E, alcohol <5%E, glycaemic index high, energy density high, energy intake ad libitum Modified fat aims: 35‐45%E from fat, SFA <10%E, MUFA >20%E, PUFA 5‐10%E, protein 10‐20%E, CHO 40‐50%E, added sugars <10%E, alcohol <5%E, glycaemic index low, energy density high, energy intake ad libitum Control and intervention methods: supermarket model, all foods provided free, personal shoppers helped participants collect appropriate foods, not allowed to leave shop until dietary composition was correct, waste and leftovers returned to shop, minimum of 2 dietetic counselling sessions over 2 months. Total fat intake (at 6 months): mod fat 38.4 (sd 1.75)%E, cont 32.1 (sd 1.62)%E Saturated fat intake (at 6 months): mod fat 7.1 (sd 0.80)%E, cont 15.1 (sd 1.0)%E Style: food provided Setting: community |
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| Outcomes | Stated trial outcomes: CVD risk, diabetes risk, weight
Data available on total mortality? yes (no events)
Cardiovascular mortality? yes (no events)
Events available for combined cardiovascular events: total MI, stroke (no events) Secondary outcomes: cancer deaths and diagnoses, total and non‐fatal MI, stroke (no events in any group) Tertiary outcomes: weight, BMI, total, HDL, LDL cholesterol, TG |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Independently randomised by 2 study personnel, stratified by sex and initial BMI |
| Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
| Blinding (performance bias and detection bias) All outcomes | High risk | Participants were aware of their own allocated diet, those assessing outcomes unclear |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for dropouts provided, ITT analysis used for continuous 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 | Yes, advice and shop system was the same across all groups |
| Free of dietary differences other than fat? | High risk | No, there were also differences in sugary foods, legumes, dietary glycaemic index etc |