Table 1.

Assessments and procedures during study visits

Procedure visit window (days)	SCR ±7	W0	W1 ±3	W2 ±3	W4 ±3	W8 ±3	W12 ±3	W16 ±3	W20 ±3	W24 ±3
Visit	1	2	3	4	5	6	7	8	9	10
Informed consent	X
Inclusion exclusion criteria	X	X
Randomisation criteria and randomisation		X
Medical history	X
Physical examination	X
Indirect calorimetry		X	X	X	X	X	X	X	X	X
Full blood count	X
Renal profile	X
Lipid profile		X								X
Liver function test	X									X
Thyroid function	X
GLP1, GIP, PYY		X								X
Fasting glucose		X								X
HbA1c	X									X
Urine pregnancy test	X
Height	X
Weight	X	X	X	X	X	X	X	X	X	X
Waist, hip, thigh circumference		X		X	X	X	X	X	X	X
FFM, FM		X		X	X	X	X	X	X	X
Blood pressure	X	X			X	X	X	X	X	X
Diet counselling		X			X	X	X	X	X	X
Food diary		X	X	X	X	X	X	X	X	X
Compliance check			X	X	X	X	X	X	X	X
IPAQ		X					X			X
Meal test		X								X
CGM		X			X		X			X
Concomitant medication check	X	X	X	X	X	X	X	X	X	X
AE reporting		X			X	X	X	X	X	X
KOSC	X									X
ESS	X									X
STOP-BANG	X									X
IWQoL-Lite		X								X
EuroQoL-5D-5L		X								X
Acceptability survey		X								X

W0, week 0; W1, week 1; W2, week 2; W4, week 4;W8, week 8; W12, week 12; W16, week 16; W20, week 20; W24, week 24.

AE, adverse events; CGM, Continuous Glucose Monitor; EQ-5D-5L, EuroQoL-5 Dimension-5 Level; ESS, Epworth sleep score; ESS, Epworth Sleep Score; FFM, fat-free mass; FM, fat mass; GIP, gastric inhibitory polypeptide; GLP-1, glucagon-like peptide 1; HbA1c, glycated haemoglobin; IPAQ, International Physical Activity Questionnaire; IWQoL, Lite- Questionnaire for quality of life; KOSC, King’s obesity staging criteria; PYY, peptide YY; SCR, screening visit; STOP-BANG, screening questionnaire for obstructive sleep apnoea.