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

Catenacci 2016.

Study characteristics
Methods Parallel randomised clinical trial
Participants 29 participants based in the USA aged between 18 and 55 years with a BMI > 30.
Inclusion criteria: (18‐55 years, BMI ≥30 kg/m2, non‐smoker, ≤4.5 kg weight change over past 6 months) were invited to a screening visit.
Exclusion criteria: volunteers were excluded if they had diabetes, CVD, uncontrolled hypertension, severe dyslipidaemia (or were on lipid‐lowering therapy), cancer, thyroid disease, seizures, migraines, significant renal, hepatic or gastrointestinal disorders, binge eating disorder, current depression, history of bariatric surgery, or were taking medications known to affect appetite or energy metabolism. Women who were currently pregnant, planning pregnancy, or lactating were also excluded.
Interventions 2‐arm trial
Intervention (n = 13): zero‐calorie alternate day fasting
Comparator (n = 12): continuous calorie restriction
Outcomes Body weight, BMI, lipid profile, glucose
Notes Type of paper: full‐text publication
Funding: NIH R21 AT002617‐02, NIH UL1 TR001082, NIH DK 048520, the Colorado Obesity Research Institute (CORI), and the Intramural Research Program of the National Institute on Aging. Dr. Melanson is supported with resources and the use of facilities at the Denver VA Medical Center.
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) Unclear risk There was no mention of a method for allocation sequence concealment.
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High rates of dropout; Of the 45 people who consented at screening, 16 participants (35.6%) either dropped out or were withdrawn prior to randomisation. Then, 1 of the 15 participants (6.67%) in the ADF group dropped out from the 8‐week intervention, and 2 out of 14 participants (14.3%) withdrawn from the CR group in this period. By the 24‐week follow‐up, the dropout rate was 21.4% (3 out of 14 participants) in the ADF group and 16.7% (2 out of 12 participants) in the CR group.
Selective reporting (reporting bias) Unclear risk Not stated.
Other bias Low risk Nothing to note.