Carter 2018.
Study characteristics | ||
Methods | Parallel‐arm randomised clinical trial | |
Participants | 137 participants based in Australia aged ≥ 18 years with type 2 diabetes who were overweight or obese (BMI ≥ 27). Inclusion criteria: adults (≥18 years of age) with type 2 diabetes who were overweight or obese (BMI ≥ 27 [calculated as weight in kilograms divided by height in meters squared]) Exclusion criteria: pregnant or breastfeeding. |
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Interventions |
2‐arm trial Intervention (n = 70): intermittent energy restriction group followed a diet of 500 to 600 kcal/day for 2 days of the week and followed their usual diet for the other 5 days. Comparator (n = 67): continuous energy restriction |
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Outcomes | Body weight, BMI, HbA1c | |
Notes |
Type of paper: abstract Funding: Ms Carter was supported by a University of South Australia postgraduate award. Dr Clifton was supported by a National Health and Medical Research Council principal research fellowship. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"Randomization was completed using an online generated random number allocation sequence and was not blinded; participants were allocated to groups by the study dietitian according to the randomization schedule." |
Allocation concealment (selection bias) | High risk | There was lack of blinding when assigning the interventions to the participants; quote:"participants were allocated to groups by the study dietitian." |
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 | High rates of dropout; quote: "97 participants (70.8%) completed the study, and the dropout rates were similar in both groups (21 participants [31.3%] in the continuous energy restriction group and 19 participants [27.1%] in the intermittent energy restriction group; P = .71)." |
Selective reporting (reporting bias) | Unclear risk | Not stated. |
Other bias | Low risk | Nothing to note. |