Seppelt 1996.
| Methods | RCT | |
| Participants | Women with BMI 24‐29 (Germany) CVD risk: low Control: randomised 35, analysed 32 Intervention: randomised 35, analysed 35 Mean years in trial: control 0.7, intervention 0.8 % male: 0 Age: mean control 46, intervention 48 (all 40‐60) | |
| Interventions | Reduced fat vs usual diet Control aims: advice to buy foods from trial shop, usual fat foods supplied Intervention aims: advice to buy foods from trial shop, low fat foods supplied Control methods: trial shop provided ad libitum usual fat foods Intervention methods: trial shop provided ad libitum low fat foods Total fat intake (at 9 months): low fat 35.1 (sd unclear), cont 35.5 (sd unclear)%E Saturated fat intake: unclear Style: food provided Setting: community |
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| Outcomes | Stated trial outcomes: weight
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 for any outcomes) Tertiary outcomes: weight, total, LDL and HDL cholesterol, TG |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "participants assigned to a random number, later numbers sorted & assigned" |
| Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding unclear for participants and researchers |
| 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? | Low risk | Trial shop for 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 |