Table 2.
Primary, secondary, and exploratory outcomes by group allocation
| Outcomes | Mean (SD) change from baseline | Adjusted difference (95% CI) | P value | ||||
|---|---|---|---|---|---|---|---|
| Usual care group | No | TDR group | No | ||||
| 3 months: | |||||||
| Weight (kg)* | −3.3 (4.2) | 97 | −13.3 (6.3) | 114 | −9.6 (−11.0 to −8.2) | <0.001 | |
| Waist circumference (cm)† | −4.6 (4.9) | 94 | −13.1 (7.7) | 111 | −8.1 (−9.9 to −6.4) | <0.001 | |
| Fat mass (kg)† | −3.0 (4.3) | 95 | −10.7 (6.2) | 109 | −7.1 (−8.6 to −5.6) | <0.001 | |
| Systolic blood pressure (mm Hg)† | 3.5 (15.2) | 96 | −2.6 (15.8) | 113 | −5.8 (−9.1 to −2.4) | 0.001 | |
| Diastolic blood pressure (mm Hg)† | 0.5 (8.9) | 96 | −4.4 (9.3) | 113 | −3.9 (−5.9 to −1.8) | 0.001 | |
| 6 months: | |||||||
| Weight (kg)* | −4.5 (6.2) | 94 | −15.1 (8.7) | 108 | −9.6 (−11.6 to 7.7) | <0.001 | |
| Waist circumference (cm)† | −7.0 (7.2) | 89 | −15.4 (9.7) | 102 | −8.3 (−10.6 to −6.0) | <0.001 | |
| Fat mass (kg)† | −4.8 (5.6) | 86 | −12.8 (9.6) | 94 | −7.9 (−9.9 to −5.9) | <0.001 | |
| Systolic blood pressure (mm Hg)† | 4.0 (14.0 | 92 | 0.3 (16.7) | 105 | −3.3 (−6.9 to 0.3) | 0.07 | |
| Diastolic blood pressure (mm Hg)† | 0.4 (9.3) | 92 | −3.5 (11.4) | 105 | −2.8 (−5.2 to −0.4) | 0.02 | |
| Quality of life: | |||||||
| EQ-5D (index)† | 0.03 (0.15) | 73 | 0.07 (0.20) | 92 | |||
| EQ-5D (VAS)† | 7.0 (17.5) | 74 | 15.5 (18.2) | 93 | |||
| OWL-QOL† | 10.6 (14.8) | 74 | 17.4 (20.5) | 92 | |||
| 12 months: | |||||||
| Weight (kg)‡ | −3.1 (7.0) | 95 | −10.7 (9.6) | 104 | −7.2 (−9.4 to −4.9) | <0.001 | |
| No (%) lost ≥5% weight | 30 (31.6) | 95 | 76 (73.1) | 104 | 6.5§ (3.4 to 12.2) | <0.001 | |
| No (%) lost at least ≥10% weight | 14 (14.7) | 95 | 47 (45.1) | 104 | 4.9§ (2.4 to 9.9) | <0.001 | |
| Waist circumference (cm)† | −5.5 (7.3) | 91 | −10.5 (9.1) | 99 | −6.0 (−8.2 to −3.7) | <0.001 | |
| Fat mass (kg)* | −4.1 (6.5) | 93 | −10.4 (8.5) | 100 | −5.8 (−7.9 to −3.7) | <0.001 | |
| Systolic blood pressure (mm Hg)* | 2.9 (15.2) | 93 | −1.6 (16.4) | 100 | −2.9 (−6.4 to 0.6) | 0.1 | |
| Diastolic blood pressure (mm Hg)* | 0.3 (9.3) | 93 | −4.2 (11.1) | 100 | −3.1 (−5.5 to −0.7) | 0.01 | |
| HbA1c (mmol/mol)* | −1.0 (7.7) | 75 | −3.2 (8.8) | 91 | −2.2 (−4.4 to 0.0) | 0.05 | |
| Fasting glucose (mmol/L)† | 0.1 (1.3) | 75 | −0.5 (1.8) | 89 | −0.4 (−0.8 to −0.1) | 0.02 | |
| Fasting insulin (pmol/L)† | −10.4 (91.6) | 72 | −21.8 (41.8) | 87 | −18.0 (−32.0 to −4.0) | 0.01 | |
| HOMA-IR† | −0.1 (1.5) | 70 | −0.5 (1.2) | 86 | −0.4 (−0.7 to-0.2) | 0.003 | |
| HOMA-β (%)† | −15.0 (83.8) | 70 | −12.5 (39.7) | 86 | −9.8 (−22.9 to 3.4) | 0.15 | |
| HOMA-S (%)† | −4.6 (70.4) | 70 | 28.8 (47.5) | 86 | 30.9 (16.4 to 45.5) | <0.001 | |
| Total cholesterol (mmol/L) | 0.0 (0.9) | 78 | −0.2 (0.9) | 91 | −0.2 (−0.5, 0.04) | 0.11 | |
| HDL cholesterol (mmol/L)† | 0.1 (0.3) | 78 | 0.2 (0.3) | 91 | 0.1 (0.0 to 0.2) | 0.09 | |
| LDL cholesterol (mmol/L)* | −0.1 (0.7) | 73 | −0.1 (0.6) | 87 | 0.0 (−0.2 to 0.2) | 0.8 | |
| Triglycerides (mmol/L)† | 0.1 (0.6) | 76 | −0.3 (1.0) | 89 | −0.4 (−0.6 to −0.1) | 0.002 | |
| QRISK2 (%)† | 0.0 (2.1) | 88 | −0.9 (2.6) | 100 | −1.0 (−1.7 to −0.3) | 0.01 | |
| Quality of life: | |||||||
| EQ-5D (index)† | 0.07 (0.14) | 93 | 0.09 (0.17) | 100 | |||
| EQ-5D (VAS)† | 9.2 (17.0 | 96 | 13.0 (18.7) | 101 | |||
| OWL-QOL† | 14.0 (16.7) | 94 | 17.0 (20.9) | 99 | |||
VAS=visual analogue scale; OWL-QOL=obesity and weight loss quality of life; HOMA=homeostatic model assessment; HOMA-IR=insulin resistance; HOMA-β=steady state β cell function; HOMA-S=insulin sensitivity; HDL=high density lipoprotein; LDL=low density lipoprotein.
*
Secondary outcome.
†
Exploratory outcome.
‡
Primary outcome.
§
Odds ratio.