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 |
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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) |
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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 |
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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 |