Background
Methods
Design
Recruitment
Intervention
Measurements
Statistical analyses
Ethics
Results
Baseline characteristics of completers and non-completers
Characteristic | Completers (n = 237) mean (SD) | Non-completers (n = 74) mean (SD) | P value |
---|---|---|---|
Age (yr) | 56.7 (8.7) | 57.2 (9.5) | 0.705 |
Weight (kg) | 91.7 (17.7) | 95.3 (19.6) | 0.145 |
Body-mass index (kg/m2) | 33.5 (5.9) | 34.7 (6.9) | 0.144 |
Waist circumference (cm) | 104.9 (13.0) | 109.6 (14.9) | 0.009 |
Hip circumference (cm) | 115.7 (12.5) | 117.6 (13.9) | 0.257 |
Plasma glucose (mmol/l) | |||
Fasting | 5.53 (0.54) | 5.46 (0.51) | 0.298 |
2 Hr oral glucose challenge | 6.71 (1.68) | 6.61 (1.72) | 0.644 |
Serum lipids (mmol/l) | |||
Total cholesterol | 5.67 (1.15) | 5.42 (0.98) | 0.102 |
Low-density lipoprotein cholesterol | 3.44 (0.99) | 3.25 (0.80) | 0.097 |
High-density lipoprotein cholesterol | 1.34 (0.37) | 1.26 (0.34) | 0.082 |
Triglycerides | 1.94 (1.05) | 2.02 (1.14) | 0.569 |
Blood pressure (mm Hg) | |||
Systolic | 132.1 (17.1) | 135.0 (18.8) | 0.216 |
Diastolic | 81.0 (9.9) | 82.6 (11.7) | 0.265 |
HADS anxiety | 3.6 (3.3) | 5.4 (4.0) | <0.0005 |
HADS depression | 2.8 (2.9) | 4.1 (3.9) | 0.014 |
Kessler 10 (psychological distress) | 15.3 (5.4) | 19.0 (8.0) | <0.0005 |
SF-36 v2 | |||
Physical functioning | 78.3 (18.6) | 66.3 (26.3) | 0.001 |
Role limitation physical | 78.6 (22.4) | 67.3 (29.6) | 0.008 |
Bodily pain | 63.0 (23.9) | 57.8 (27.5) | 0.107 |
General health perception | 65.9 (18.6) | 61.0 (18.9) | 0.034 |
Vitality | 56.4 (19.2) | 50.1 (23.8) | 0.023 |
Social functioning | 83.2 (20.3) | 75.2 (27.3) | 0.055 |
Role limitation emotional | 85.4 (21.0) | 76.9 (27.3) | 0.026 |
Mental health | 75.7 (17.0) | 66.5 (20.5) | <0.0005 |
Years of education | 12.1 (3.4) | 10.7 (3.1) | 0.002 |
Clinical outcomes for completers
n | Baseline mean (SD) | Change from baseline to 3 months* mean (95% CI) | Change from baseline to 12 months mean (95% CI) | Change at 12 months % | |
---|---|---|---|---|---|
Weight (kg) | 237 | 91.7 (17.7) | -2.38 (-2.79,-1.98) | -2.52 (-3.19,-1.85) | -2.7 |
Body-mass index (kg/m2) | 237 | 33.5 (5.9) | -0.88 (-1.03,-0.74) | -0.93 (-1.17,-0.69) | -2.8 |
Waist circumference (cm) | 236 | 104.9 (13.0) | -3.16 (-3.72,-2.60) | -4.17 (-4.87,-3.48) | -4.0 |
Hip circumference (cm) | 236 | 115.7 (12.5) | -1.56 (-2.04,-1.07) | -2.65 (-3.26,-2.05) | -2.3 |
Plasma glucose (mmol/l) | |||||
Fasting | 237 | 5.53 (0.54) | 0.00 (-0.07,0.08) | -0.14 (-0.20,-0.07) | -2.5 |
2 Hr oral glucose challenge | 232 | 6.70 (1.69) | - | -0.58 (-0.79,-0.36) | -8.6 |
Serum lipids (mmol/l) | |||||
Total cholesterol | 237 | 5.67 (1.15) | -0.21 (-0.32,-0.09) | -0.29 (-0.40,-0.18) | -5.1 |
Low-density lipoprotein cholesterol | 229 | 3.44 (0.99) | -0.16 (-0.25,-0.07) | -0.25 (-0.34,-0.16) | -7.3 |
High-density lipoprotein cholesterol | 237 | 1.34 (0.37) | 0.01 (-0.02,0.03) | 0.06 (0.03,0.09) | +4.4 |
Triglycerides | 237 | 1.90 (1.00) | -0.10 (-0.20,0.01) | -0.15 (-0.24,-0.05) | -7.6 |
Blood pressure (mmHg) | |||||
Systolic | 236 | 132.1 (17.1) | -1.67 (-3.3,-0.04) | -1.01 (-2.60,0.58) | -0.8 |
Diastolic | 236 | 81.0 (9.9) | -0.99 (-2.18,0.20) | -2.14 (-3.33,-0.94) | -2.6 |
Psychological and general health outcomes
n | Baseline mean (SD) | Change from baseline to 12 months mean (95% CI) | Effect size | P value | ||
---|---|---|---|---|---|---|
Kessler 10 | Psychological distress | 226 | 15.1 (5.2) | 14.6 (5.6) | +0.10 | 0.002 |
HADS | Depression | 224 | 2.8 (2.9) | 2.5 (3.0) | +0.10 | 0.008 |
SF-36 v2 | Physical Functioning | 229 | 78.5 (18.1) | 80.1 (19.9) | -0.09 | 0.012 |
Role-Physical | 230 | 78.7 (22.3) | 78.3 (24.0) | +0.02 | 0.664 | |
Bodily Pain | 232 | 63.0 (23.9) | 66.4 (24.7) | -0.14 | 0.019 | |
General Health | 229 | 65.9 (18.6) | 71.3 (17.7) | -0.29 | <0.0005 | |
Vitality | 230 | 56.5 (19.2) | 61.2 (18.9) | -0.25 | <0.0005 | |
Social Functioning | 232 | 83.1 (20.4) | 82.7 (23.1) | +0.02 | 0.821 | |
Role-Emotional | 230 | 85.3 (21.2) | 85.7 (21.4) | -0.02 | 0.726 | |
Mental Health | 230 | 75.9 (16.8) | 78.4 (16.1) | -0.15 | 0.025 |