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

Bhutani 2013.

Study characteristics
Methods Randomised, controlled, parallel‐arm feeding trial
Participants 83 participants based in the USA aged between 25‐65 years. BMI between 30 and 39.9 kg/m2.
Inclusion criteria: age 25‐65 years; BMI between 30 and 39.9 kg/m2; weight stable for 3 months prior to the beginning of the study (i.e. less than 5 kg weight loss or weight gain); nondiabetic; no history of cardiovascular disease; lightly active (i.e. <3 hours/week of light intensity exercise at 2.5‐4.0 metabolic equivalents [METs] for 3 months prior to the study); nonsmoker; no history of bariatric surgery; and not taking weight loss, lipid, or glucose lowering medications.
Exclusion criteria: peri‐menopausal women were excluded from the study, and post‐menopausal women (absence of menses for more than 2 years) were required to maintain their current hormone replacement therapy regimen for the duration of the study.
Interventions 4‐arm trial
Intervention (n = 16): modified Alternate Day fasting (ADF) (25% of normal)
Comparator (n = 16):a d libitum feeding
Other arms not included: combination (ADF+ exercise) and exercise‐alone arm
Outcomes Body weight, waist circumference, blood pressure
Notes Type of paper: full‐text publication
Funding:
  • American Heart Association. Grant Number: 12PRE8350000

  • University of Illinois, Chicago, Departmental funding


ADF‐ alternate day fasting
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomization was performed for each stratum by selecting an intervention at random from an opaque envelope."
Allocation concealment (selection bias) Low risk Quote:"Randomization was performed for each stratum by selecting an intervention at random from an opaque envelope."
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 Additional participants were randomised to groups that had high dropout rates (i.e. the ADF and exercise group) to ensure that the total number of participants would be the same in each group at the end of the study.
Selective reporting (reporting bias) Unclear risk Not stated.
Other bias Low risk Nothing to note.