Sundfor 2018.
Study characteristics | ||
Methods | Randomised clinical trial | |
Participants | 112 participants based in Norway aged between 21 and 70 with a BMI of 30 to 45.0 kg/m2 Inclusion criteria: waist circumference ≥94/80 cm (men/women) and ≥1 additional metabolic syndrome component: circulating levels of TG ≥ 1.7 mmol/L, HDL cholesterol ≤1.0/1.3 (men/women), blood pressure ≥130/85 mmHg or use of antihypertensive drugs or fasting glucose ≥5.6 mmol/L, and weight stability within ±3 kg during the last three months. Exclusion criteria: diabetes if treated with insulin or incretin analogues, bariatric surgery, use of anti‐obesity drugs or other drugs affecting body weight, eating disorder, or psychiatric illness, or alcohol or drug abuse that could contribute to difficulties with study procedures. |
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Interventions |
2‐arm trial Intervention (n = 54): twice‐weekly diet. Participants in the intermittent energy restriction group were advised to consume 400/600 (female/male) on each of two nonconsecutive days a week and to consume food as usual the remaining five days a week. Comparator (n = 58): continuous energy restriction |
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Outcomes | Body weight, BMI, Waist circumference, lipid profile, blood pressure, glucose, CRP | |
Notes |
Funding: not stated Type of paper: full‐text publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A statistician prepared a computer‐generated random number list" |
Allocation concealment (selection bias) | Low risk | The project leader (TS) opened numbered and sealed envelopes consecutively with no exception. |
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 | Quote:"Measurements were not blinded, but data entry was done by assistants who were blinded to study group." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout rates in both groups and intention‐to‐treat analysis was performed; at 12 months, 4 out of 54 (7.4%) dropout rate in the IER group dropouts and 3 out of 58 (5.2%) dropout rate in the CER group. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes (www.clinicaltrials.gov NCT02480504) were reported. |
Other bias | Unclear risk | Study visits were not scheduled according to fasting days among participants in the intermittent energy restriction group, to limit lack of compliance, as participants were allowed to vary the day of the week on which they fasted. |