Hutchison 2019.
Study characteristics | ||
Methods | Multiple‐arm randomised controlled clinical trial | |
Participants | 88 female participants based in Australia aged between 35 and 70 years with a BMI between 25‐42 kg/m2 Inclusion and exclusion criteria: patients were aged 35 to 70 years; BMI 25 to 42 kg/m2; weight stable (±5% of their screening weight) for > 6 months prior to study entry; nondiabetic; nonsmoker; sedentary or lightly active (i.e., < 2 moderate‐ to high‐intensity exercise sessions/week); consumed < 140 g alcohol per week; no history of CVD, eating disorders, or psychiatric disorders (including those taking antidepressants); not pregnant or breastfeeding; and not taking medication that may affect study outcomes (e.g. phentermine, orlistat, metformin, excluding antihypertensive/lipid‐lowering medication). |
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Interventions |
4‐arm trial: IF100, IF70, DR70, Control (ad libitum feeding) Interventions (n = 22, n = 22): IF100, IF70 (Both were used in this analysis) Comparator (n = 24, n = 11): DR70, Control |
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Outcomes | Body weight, waist circumference, lipid profile, blood pressure, glucose | |
Notes |
Type of paper: full‐text publication Funding: the research was funded by a National Health and Medical Research Council (NHMRC) Project Grant APP1023401. LKH was supported by an Australian Research Council Future Fellowship FT120100027. BL was supported by an Australian Government Research Training Program Scholarship. Control (C): continuous energy intake at 100 % of baseline energy requirements; IF100: intermittent fasting diet at 100 % of baseline energy requirements; IF70: intermittent fasting diet at 70 % of baseline energy requirements; DR70: continuous energy restriction at 70 % of baseline energy requirements. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated. |
Allocation concealment (selection bias) | Low risk | Although block randomisation was performed, the block sizes varied between 4 and 8 participants, which reduces the risk of determining allocations. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Since this trial was a dietary intervention study, it was not feasible for participants or all study personnel to be blinded to the group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout rates varied substantially between two of the groups that had different interventions (12% for the IF70 and IF100 groups but 4% for the DF70 group), and different reasons were provided for dropout although it was not stated what reasons corresponded to which group. |
Selective reporting (reporting bias) | High risk | Outcomes of interest that were pre‐specified in the clinical trial registry (ClinicalTrials.gov: NCT01769976) were not reported in the published study, including energy expenditure, hunger, mood and cognitive function. |
Other bias | Low risk | Nothing to note. |