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. 2017 Mar 14;2017(3):CD006887. doi: 10.1002/14651858.CD006887.pub4

Soureti 2011.

Study characteristics
Methods Randomised controlled trial, parallel group (1:1:1:1)
Participants Men and women age 30‐60 years with obesity (BMI ≥ 29 kg/m²)
Exclusion criteria: diagnosis of a heart condition or cancer, being pregnant
Total randomised at baseline 781 participants (n = 197 to CVD risk message, n = 194 to CVD risk message + automated health planning tool, n = 195 to health planning tool alone, n = 195 to educational information (control)
Mean age: 47 years. Few baseline characteristics presented
Interventions Participants randomised to 1 of 3 intervention groups: a CVD risk message, CVD risk message + automated health planning tool, health planning tool alone
Comparison group: educational information about diet low in saturated fats without CVD risk message or planning tool
For this systematic review, data for participants in the 2 CVD risk message groups were combined and compared with participants in the 2 groups that did not receive a CVD risk message (n = 392 intervention group, n = 389 comparison group)
Outcomes Primary outcome: saturated fat intake as measured by self‐reported food‐frequency questionnaire, 2‐item scale to evaluate consumption of low‐fat foods
Secondary outcomes: CVD risk perception, intention to reduce saturated fat intake, self‐efficacy, planning and outcome expectancies
Total analysed in follow‐up 581 participants (n = 141 in CVD risk message group, n = 137 in CVD risk message + automated health planning tool, n = 141 in automated health planning tool alone, n = 141 in educational information (control)
For this systematic review, n = 278 in CVD risk groups, n = 282 in comparison groups
Follow‐up: 5 weeks
Study funding sources Unilever funded and created the Heart Age score tested in the study
Notes Internet‐based trial with a large amount of missing data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not reported
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Method of blinding not reported
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcomes were patient‐reported
Incomplete outcome data (attrition bias)
All outcomes High risk > 20% loss to follow‐up; ITT analysis not performed
Selective reporting (reporting bias) High risk Trial registered retrospectively
Other bias High risk Trial funded by Unilever and multiple authors were employees of Unilever. Heart Age Calculator software was also proprietary of Unilever