Variable | Mean (SD) | Mean change (SD) at 12 weeksa | Mean change (SD) at 24 weeksb | Effect size at 12 weeks†| Effect size at 24 weeks††| ||
---|---|---|---|---|---|---|---|
Baseline | 12 weeks | 24 weeks | |||||
Hemoglobin A1C, % | 9.3 (1.6) | 8.9 (1.8) | 10.3 (3.2) | − 0.4 (0.8) | 0.9 (3.6) | − 0.27 | 0.58 |
Fasting glucose, mg/dL | 195.8 (121.9) | 172.9 (52.9) | 206.4 (109.0) | − 22.9 (126.4) | 10.6 (124.1) | − 0.19 | 0.09 |
HDL cholesterol, mg/dL | 46.5 (11.7) | 44.7 (10.3) | 44.3 (13.2) | − 1.7 (5.6) | − 2.2 (6.2) | − 0.15 | − 0.19 |
LDL cholesterol, mg/dL | 92.5 (25.2) | 84.4 (19.4) | 83.5 (23.0) | − 8.2 (13.1) | − 9 (23.7) | − 0.33 | − 0.36 |
Triglycerides, mg/dL | 129.1 (63.1) | 113.4 (50.0) | 141.1 (85.5) | − 15.7 (36.7) | 12 (80.2) | − 0.25 | 0.19 |
Systolic BP, mmHg | 130.0 (13.7) | 127.5 (16.7) | 130.5 (16.9) | − 2.4 (15.1) | 0.6 (15.9) | − 0.14 | 0.04 |
Diastolic BP, mmHg | 78.6 (7.1) | 86.3 (34.2) | 84.2 (8.3) | 7.7 (33.2) | 5.6 (7.8) | 1.09 | 0.79 |
BMI | 40.0 (10.4) | 39.5 (9.8) | 40.8 (9.7) | − 0.6 (1.9) | − 0.3 (3.1) | − 0.06 | − 0.03 |
LAD | 59.5 (0.9) | 58.8 (2.0) | 60 (0.0) | 0.6 (2.0) | 0.4 (0.8) | 0.69 | 0.43 |
NVS | 1.7 (1.2) | 2.3 (1.4) | 2.4 (1.5) | 0.6 (1.4) | 0.6 (1.1) | 0.46 | 0.54 |
PHQ-9 | 6.0 (5.7) | 7.0 (6.8) | 6.1 (6.0) | 0.6 (3.1) | − 0.6 (2.8) | 0.09 | − 0.10 |
DKT | 6.0 (2.3) | 7.2 (1.6) | 7.5 (2.2) | 1.2 (2.3) | 1.6 (2.3) | 0.52 | 0.68 |
DKT-insulin | 1.0 (1.2) | 1.4 (1.2) | 1.2 (1.0) | 0.4 (0.7) | 0.2 (1.2) | 0.31 | 0.15 |
SDSES | 6.9 (1.9) | 8.0 (1.5) | 7.6 (1.8) | 1.1 (2.0) | 0.6 (2.0) | 0.57 | 0.32 |
Self-care index | 3.8 (1.4) | 4.5 (1.4) | 3.9 (0.8) | 0.4 (1.6) | 0.2 (1.1) | 0.29 | 0.15 |
mMOS-SS | 38.0 (12.5) | 39.1 (9.3) | 40.3 (8.7) | 1.5 (15.2) | 4.7 (16.1) | 0.12 | 0.36 |
EQ-5 | 1.6 (0.4) | 1.6 (0.4) | 1.5 (0.4) | 0.2 (1.6) | − 0.3 (1.3) | 0.10 | − 0.14 |
EQ-5-VAS | 62.3 (25.6) | 73.3 (23.8) | 71.4 (22.0) | 8.7 (14.5) | 13.6 (25.7) | 0.30 | 0.48 |