Table 3 Secondary outcomes by group allocation, of participants assigned to the intervention programme (n = 55) or usual care (n = 60)
Intervention | Control | Estimated effect size (95% CI) | P value* | |
|---|---|---|---|---|
Weight (kg) | ||||
Baseline weight (n = 115) | 104.9 (23.5) | 110.0 (19.2) | ||
3 month weight change (n = 108) (mean, SD) | –3.6 (3.6) | –0.7 (5.9) | 2.6 (0.6 to 4.6) | 0.0069* |
12 month weight change (n = 109) (mean, SD) | –2.4 (5.3) | –2.7 (5.9) | –0.4 (–2.3 to 1.6) | |
Systolic BP (mmHg) | ||||
Baseline (n = 115) | 131.7 (13.0) | 133.6 (14.6) | ||
3 month change (n = 107) (mean, SD) | –2.1 (12.3) | –2.9 (13.0) | –0.8 (–6.0 to 4.4) | 0.92 |
12 month change (n = 105) (mean, SD) | –1.6 (14.2) | –0.9 (15.2) | 0.2 (–5.0 to 5.4) | |
Diastolic BP (mmHg) | ||||
Baseline (n = 115) | 79.0 (9.4) | 81.9 (10.0) | ||
3 month change (n = 107) (mean, SD) | –2.1 (9.1) | –3.2 (8.0) | –1.1 (–4.8 to 2.6) | 0.35 |
12 month change (n = 105) (mean, SD) | –1.0 (9.2) | –2.2 (11.2) | –1.5 (–5.2 to 2.2) | |
Lipid profile | ||||
Total cholesterol (mmol/L) | ||||
3 month change (n = 104) (mean, SD) | –0.01 (0.86) | –0.19 (0.85) | –0.12 (–0.45 to 0.20) | 0.68 |
12 month change (n = 104) (mean, SD) | –0.21 (0.61) | –0.35 (0.98) | –0.13 (–0.46 to 0.20) | |
Triglycerides (mmol/L) | ||||
3 month change (n = 94) (mean, SD) | –0.07 (1.03) | –0.29 (1.28) | –0.19 (–0.64 to 0.26) | 0.54 |
12 month change (n = 93) (mean, SD) | –0.25 (0.86) | –0.19 (1.29) | 0.06 (–0.39 to 0.51) | |
HDL cholesterol (mmol/L) | ||||
3 month change (n = 96) (mean, SD) | 0.03 (0.17) | 0.04 (0.15) | –0.01 (–0.08 to 0.11) | 0.67 |
12 month change (n = 99) (mean, SD) | 0.07 (0.39) | 0.04 (0.15) | –0.03 (–0.12 to 0.06) | |
LDL cholesterol (mmol/L) | ||||
3 month change (n = 81) (mean, SD) | –0.04 (0.52) | –0.10 (0.49) | –0.03 (–0.31 to 0.25) | 0.97 |
12 month change (n = 91) (mean, SD) | –0.22 (0.62) | –0.25 (0.78) | –0.03 (–0.30 to 0.24) | |
Total cholesterol:HDL ratio | ||||
3 month change (n = 95) (mean, SD) | –0.11 (0.71) | –0.36 (0.87) | –0.21 (–0.53 to 0.12) | 0.43 |
12 month change (n = 98) (mean, SD) | –0.35 (0.67) | –0.55 (1.09) | –0.16 (–0.48 to 0.16) | |
Liver function | ||||
ALT (iU/L) | ||||
3 month change (n = 105) (mean, SD) | –3.3 (13.0) | –2.4 (10.9) | –0.3 (–5.5 to 4.8) | 0.67 |
12 month change (n = 103) (mean, SD) | –2.1 (15.4) | –4.1 (16.6) | –2.3 (–7.5 to 3.0) | |
ALP (iU/L) | ||||
3 month change (n = 100) (mean, SD) | –2.0 (9.4) | –3.2 (12.5) | –1.0 (–7.3 to 5.2) | 0.59 |
12 month change (n = 98) (mean, SD) | –0.2 (19.1) | –4.2 (16.4) | –3.3 (–9.5 to 3.1) | |
Albumin (g/dL) | ||||
3 month change (n = 105) (mean, SD) | 0.4 (3.1) | 0.8 (3.1) | 0.4 (–0.6 to 1.4) | 0.14 |
12 month change (n = 103) (mean, SD) | –0.6 (2.3) | 0.6 (2.3) | 1.0 (0.01 to 2.1) | |
PAID score | ||||
3 month change (n = 104) (mean, SD) | –12.3 (18.1) | –11.4 (16.2) | 0.1 (–6.2 to 6.4) | 0.34 |
12 month change (n = 102) (mean, SD) | –14.8 (17.2) | –10.0 (16.5) | 4.2 (–2.1 to 10.5) | |
EQ5D-5L index value | ||||
3 month change (n = 104) (mean, SD) | 0.059 (0.135) | 0.004 (0.149) | –0.056 (–0.111 to –0.002) | 0.12 |
12 month change (n = 103) (mean, SD) | 0.041 (0.152) | 0.001 (0.014) | –0.036 (–0.091 to 0.019) | |
EQ5D-5L VAS | ||||
3 month change (n = 104) (mean, SD) | 5.2 (17.6) | 4.0 (19.7) | –1.0 (–9.0 to 7.1) | 0.75 |
12 month change (n = 102) (mean, SD) | 4.5 (12.2) | 5.9 (22.4) | 2.2 (–5.9 to 10.3) | |
Diabetes medications | ||||
Baseline number of diabetes meds | 0.9 (0.6) | 1.1 (0.9) | ||
3 month change in number of diabetes meds (mean, SD) | 0.04 (0.3) | 0.07 (0.3) | 0.03 (–0.09 to 0.2) | 0.89 |
12 month change in number of diabetes meds (mean, SD) | 0.09 (0.4) | 0.1 (0.4) | 0.009 (–0.1 to 0.1) | |
Number of participants taking antihypertensive medications | ||||
3 month change (n, %) | 0 (0) | 0 (0) | ||
12 month change (n, %) | –1 (1.8) | 0 (0) | ||
Number of participants taking lipid lowering medications | ||||
3 month change (n, %) | –1 (1.8) | 3 (5) | ||
12 month change (n, %) | –2 (3.6) | 5 (8.3) |
