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. 2021 Jan 29;2021(1):CD013496. doi: 10.1002/14651858.CD013496.pub2

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.
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
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.
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.