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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 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
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
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