Harvie 2013.
Study characteristics | ||
Methods | Multiple‐arm randomised clinical trial | |
Participants | 115 overweight women based in the UK aged between 20 and 69 with a BMI between 24–45 kg/m2 Inclusion criteria: women were eligible for the study if their BMI was 24–45 kg/m2 and/or body fat was >30% of total weight, and their reported adult weight gain since the age of 20 years exceeded 7 kg. There was no age restriction but participants entered were between 20 and 69 years of age. Exclusion criteria: women were excluded if they were currently dieting or losing weight, or suffering from diabetes, major CVD, respiratory, psychiatric or musculoskeletal morbidity. |
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Interventions |
3 arms Intervention (n = 33): periodic fasting 2 consecutive days per week consuming 25% of normal caloric intake. Comparator (n = 33): continuous energy restriction. This group was prescribed a daily energy‐restricted Mediterranean‐type diet that was relatively high in protein (25% energy) with moderate carbohydrate (45% energy from low‐glycaemic‐index carbohydrates) and moderate fat (30% fat; 15% MUFA, 8% PUFA and 7% SFA) intakes. A third trial arm included periodic fasting with ad libitum protein and fat and thus was not included in this analysis. |
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Outcomes | Lipid profile, HbA1c, glucose, body weight, waist circumference | |
Notes | Author was contacted for raw data to calculate absolute changes Type of paper: full‐text publication Funding:tThe present study was supported by the Genesis Breast Cancer Prevention (Registered Charity no. 1109839) and, in part, by the Intramural Research Program of the National Institute on Aging, Baltimore, USA. |
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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 | Group allocation was established by opaque, sealed envelopes that contained the assignment for each participant. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Anthropometric measures were performed by research dietitians who were not blinded to the treatment groups. 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 | High risk | Personnel performing laboratory measurements, and inputting and analysing trial data were blinded to group allocations. Anthropometric measures were performed by research dietitians who were not blinded to the treatment groups. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although data on all randomised participants were analysed (Intention‐to‐treat analysis), the dropout rate was high; 10 out of 38 participants (26.3%) in the intermittent energy and carbohydrate restriction (ad libitum protein and fat) group, 4 our of 37 participants (10.8%) in the intermittent energy and carbohydrate restriction group, and 13 out of 40 participants (32.5%) in the control group. |
Selective reporting (reporting bias) | Unclear risk | Outcomes unspecified. |
Other bias | Low risk | Nothing to note. |