. 2021 Jul 23;45(11):2432–2438. doi: 10.1038/s41366-021-00915-1

Table 2.

Primary, secondary and exploratory outcomes by group.

	Change from baseline (mean ± SD)				Treatment difference
	Total diet replacement	n	Usual care	n	Adjusted difference (95% CI)	p value
3 years
Weight (kg)^a	−6.3 ± 9.1	96	−2.7 ± 7.7	83	−3.3 (−5.2, −1.5)	<0.001
Lost ≥5% weight n (%)^b	44 (45.8)	96	29 (34.9)	83	OR; 1.5 (0.8, 2.8)	0.202
Lost at least ≥10% weight n (%)^b	23 (24.0)	96	11 (13.3)	83	OR; 1.9 (0.8, 4.2)	0.126
Fat mass (kg)^b	−4.9 ± 10.1	76	−1.9 ± 6.7	69	−2.4 (−4.4; −0.5)	0.016
Systolic Blood Pressure (mmHg)^b	−4.3 ± 16.4	77	0.0 ± 15.0	68	−3.7 (−7.4; 0.1)	0.057
Diastolic Blood Pressure (mmHg)^b	−1.2 ± 9.9	77	3.8 ± 10.9	68	−3.3 (−6.2; −0.4)	0.024
HbA1c (mmol/mol)^b	3.1 ± 9.8	71	−0.8 ± 6.4	61	1.9 (−0.7; 4.5)	0.152
QRISK2 (%)^b	0.98 ± 2.77	57	1.46 ± 2.15	50	−0.37 (−0.96; 0.22)	0.222
Waist circumference (cm)^c	−10.5 ± 9.1	77	−5.5 ± 7.3	70	−3.5 (−5.7; −1.4)	0.001
Fasting glucose (mmol/L)^c	−0.5 ± 1.8	59	0.1 ± 1.3	47	−0.4 (−0.8; −0.1)	0.396
Fasting insulin (pmol/L)^c	−20.6 ± 35.1	49	−25.3 ± 110.2	44	−1.7 (−17.7; −14.4)	0.839
HOMA- IR^c	−0.4 ± 0.7	47	−0.5 ± 1.7	41	0.00 (−0.3;−0.3)	0.997
HOMA β (%)^c	−17.9 ± 35.7	47	−17.1 ± 84.3	41	−4.2 (−17.7; 9.2)	0.537
HOMA S (%)^c	28.4 ± 58.6	47	20.2 ± 35.2	41	4.9 (−12.7; 22.5)	0.586
Total Cholesterol (mmol/L)^c	−0.1 ± 0.8	69	−0.2 ± 0.9	61	0.2 (−0.1, 0.4)	0.264
HDL cholesterol (mmol/L)^c	0.1 ± 0.3	69	0.1 ± 0.2	61	0.00 (−0.1; 0.1)	0.969
LDL Cholesterol (mmol/L)^b	−0.1 ± 0.7	61	−0.2 ± 0.7	56	0.1 (−0.10; 0.34)	0.295
Triglycerides (mmol/L)^c	−0.2 ± 0.6	63	−0.1 ± 0.9	58	−0.1 (−0.4; −0.1)	0.394
Quality of Life:
EQ-5D (Index)^c	0.00 ± 0.17	67	0.02 ± 0.016	70	−0.02 (−0.07; 0.03)	0.419
EQ-5D (VAS)^c	6.6 ± 19.9	79	22.6 ± 115.1	70	−18.0 (32.2; 3.8)	0.013
OWL-QOL^c	9.5 ± 16.2	77	8.1 ± 14.7	70	1.1 (−4.2; 6.5)	0.674

^aPrimary outcome.

^bSecondary outcome.

^cExploratory outcome.