Background
Methods
Study design
Participants and intervention
Measurements
Statistical analyses
Results
Baseline values
Intervention | Control | Difference | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Men | Women | Total | Men | Women | Total | Intervention-Control | |||||||
Continuous variables | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n |
p-value |
Weight (kg) | 91.3 (14.9) | 67 | 72.4 (13.2) | 89 | 80.5 (16.8) | 156 | 90.4 (12.4) | 72 | 72.9 (12.2) | 75 | 81.4 (15.1) | 147 | .599 |
BMI (kg/m2) | 27.98 (3.6) | 67 | 26.71 (4.9) | 89 | 27.26 (4.4) | 156 | 27.83 (3.2) | 72 | 26.47 (4.1) | 75 | 27.14 (3.8) | 147 | .795 |
WC (cm) | 103.4 (11.5) | 68 | 92.6 (12.3) | 90 | 97.3 (13.1) | 158 | 101.1 (8.8) | 72 | 91.4 (10.3) | 75 | 96.2 (10.7) | 147 | .422 |
HC (cm) | 106.9 (6.6) | 68 | 105.6 (9.2) | 90 | 106.1 (8.2) | 158 | 106.6 (6.3) | 72 | 106.0 (8.3) | 76 | 106.3 (7.4) | 148 | .872 |
WHR | 0.97 (0.07) | 68 | 0.88 (0.07) | 90 | 0.91 (0.08) | 158 | 0.95 (0.05) | 71 | 0.86 (0.06) | 75 | 0.90 (0.07) | 146 | .198 |
SBP (mm Hg) | 136.8 (13.6) | 68 | 127.8 (15.3) | 90 | 131.6 (15.2) | 158 | 133.1 (15.7) | 73 | 132.1 (17.5) | 76 | 132.6 (16.6) | 149 | .605 |
DBP (mm Hg) | 86.7 (9.0) | 68 | 79.0 (8.7) | 90 | 82.3 (9.6) | 158 | 85.0 (10.2) | 73 | 82.2 (8.9) | 76 | 83.5 (9.6) | 149 | .258 |
Cholesterol (mmol/L) | 5.6 (1.0) | 41 | 6.3 (1.2) | 48 | 6.0 (1.2) | 89 | 5.8 (1.1) | 57 | 6.5 (1.1) | 55 | 6.1 (1.2) | 112 | .401 |
HbA1c (mmol/mol) | 38.2 (7.7) | 70 | 36.7 (4.1) | 95 | 37.4 (5.9) | 165 | 37.9 (10.3) | 85 | 37.0 (3.4) | 88 | 37.4 (7.6) | 173 | .893 |
Fp glucose (mmol/L) | 6.3 (1.4) | 68 | 5.6 (0.6) | 88 | 5.9 (1.1) | 156 | 6.3 (1.4) | 79 | 5.7 (0.67) | 83 | 6.0 (0.9) | 162 | .347 |
Alcohol consumptiona
| 38.3 (31.3) | 61 | 20.3 (19.7) | 57 | 29.6 (27.8) | 118 | 42.8 (35.2) | 79 | 21.0 (18.9) | 68 | 32.7 (30.7) | 147 | .398 |
Categorical variables | % | % | % | % | % | % | |||||||
Low physical activityb
| 83.3 | 66 | 73.9 | 88 | 77.9 | 154 | 75.0 | 84 | 74.7 | 87 | 74.9 | 171 | .516 |
Unfavourable dietc
| 69.2 | 52 | 43.1 | 65 | 54.7 | 117 | 74.6 | 67 | 28.2 | 71 | 50.7 | 138 | .526 |
Daily smokers | 7.4 | 68 | 12.6 | 87 | 10.3 | 155 | 10.8 | 83 | 11.8 | 85 | 11.3 | 168 | .776 |
Between group differences
Intervention | Control | Between groups | Effect size | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Men | Women | Total | Men | Women | Total | ||||||||||
Continuous variables | Mean (SD) |
p-value | Mean (SD) |
p-value | Mean (SD) |
p-value | Mean (SD) |
p-value | Mean (SD) |
p-value | Mean (SD) |
p-value | Mean (SEdiff) |
p-value | |
Weight (kg) | −0.6 (3.7) | .181 | −0.9 (3.3) | .009 | −0.8 (3.4) | .005 | −0.1 (3.0) | .773 | −0.21 (3.2) | .571 | −0.2 (3.1) | .538 | 0.6 (0.38) | .093 | |
BMI (kg/m2) | −0.22 (1.1) | .132 | −0.44 (1.3) | .002 | −0.35 (1.2) | .001 | −0.08 (1.1) | .548 | −0.02 (1.2) | .897 | −0.05 (1.2) | .622 | 0.31 (0.14) | .031 | .25 |
WC (cm) | −2.3 (5.6) | .001 | −1.0 (4.7) | .057 | −1.5 (5.1) | ≤ .001 | −0.2 (4.0) | .720 | 1.4 (5.1) | .019 | 0.6 (4.7) | .105 | 2.1 (0.56) | ≤ .001 | .44 |
WHR | −0.02 (0.1) | .009 | 0.00 (0.1) | .380 | −0.01 (0.1) | .013 | 0.00 (0.0) | .665 | 0.01 (0.1) | .018 | 0.01 (0.0) | .034 | 0.02 (0.01) | ≤ .001 | .38 |
SBP (mm Hg) | −2.6 (13.7) | .121 | −0.7 (13.3) | .636 | −1.5 (13.5) | .163 | −1.0 (13.9) | .541 | −0.95 (14.8) | .578 | −1.0 (14.3) | .408 | 1.00 (1.59) | .740 | |
DBP (mm Hg) | −2.1 (9.6) | .073 | 1.2 (8.8) | .215 | −0.3 (9.3) | .731 | −0.5 (10.4) | .669 | 0.47 (7.3) | .572 | 0.0 (8.9) | .985 | 0.3 (1.04) | .817 | |
S-cholesterol (mmol/L) | −0.2 (0.8) | .095 | −0.2 (1.2) | .341 | −0.2 (1.1) | .085 | −0.1 (0.9) | .412 | −0.1 (1.0) | .322 | −0.1 (0.9) | .196 | 0.1 (0.14) | .574 | |
HbA1c (mmol/mol) | −0.3 (2.9) | .430 | −0.6 (2.2) | .006 | −0.5 (2.5) | .013 | −0.5 (7.1) | .506 | 0.1 (1.9) | .528 | −0.3 (5.2) | .419 | −0.17 (0.44) | .698 | |
Fp glucose (mmol/L) | 0.1 (0.8) | .610 | 0.0 (0.4) | .980 | 0.0 (0.6) | .668 | −0.2 (0.8) | .071 | 0.0 (0.5) | .569 | −0.1 (0.7) | .065 | −0.1 (0.07) | .102 | |
Alcohol consumption | −0.5 (22.9) | .857 | −1.8 (12.0) | .365 | −1.0 (18.4) | .566 | −5.3 (19.9) | .021 | −2.6 (13.3) | .117 | −4.0 (17.2) | .005 | −3.0 (2.19) | .167 | |
Categorical variables | % |
p-value | % |
p-value |
%
|
p-value | % |
p-value | % |
p-value | % |
p-value | |||
Unfavourable diet | 0.0 | 1.000 | −20.0 | .004 | −11.1 | .031 | −6.0 | .424 | 1.8 | .815 | −0.6 | .860 | |||
Low physical activity | −7.5 | .180 | −5.7 | .267 | −6.5 | .052 | −3.5 | .549 | 1.2 | 1.000 | −1.2 | .855 | |||
Daily smokers | 1.5 | 1.000 | 2.3 | .625 | −0.6 | 1.000 | 0.0 | 1.000 | 0.0 | 1.000 | 0.0 | 1.000 |
Within group differences
Analysis in the subgroup with elevated risk at baseline
Intervention | Control | Between group differences | Cohen’s d | ||||||
---|---|---|---|---|---|---|---|---|---|
Continuous variables | Mean (SD) |
p-value | n= | Mean (SD) |
p-value | n= | Mean (95% CI) |
p-value | |
Weight (kg) | - 1.6 (4.1) | .004 | 59 | - 0.1 (3.8) | .817 | 62 | 1.49 (0.7, 2.9) | .039 | .38 |
BMI (kg/m2) | - .62 (1.44) | .002 | 59 | - 0.10 (1.5) | .585 | 62 | .52 (0.0, 1.0) | .052 | |
WC (cm) | - 2.82 (5.5) | ≤ .001 | 99 | - 0.1 (4.7) | .892 | 89 | 2.75 (1.3, 4.2) | ≤ .001 | .54 |
WHR | - .025 (0.1) | ≤ .001 | 99 | - 0.00 (0.0) | .938 | 89 | .03 (0.0, 0.0) | ≤ .001 | .52 |
S-cholesterol | - .29 (1.0) | .015 | 72 | - 0.16 (1.0) | .109 | 95 | .13 (−0.2, 0.4) | .398 | |
SBP | 7.04 (14.1) | ≤ .001 | 52 | −7.19 (17.6) | .005 | 52 | .15 (−6.4, 6.0) | .961 | |
Alcohol consumption | - 4.7 (22.1) | .090 | 67 | - 7.7 (19.9) | ≤ .001 | 89 | 3.05 (−9.7, 3.6) | .367 | |
Categorical variables | % | % | |||||||
Unfavourable diet | −34.4 | ≤ .001 | 64 | −24.3 | ≤ .001 | 70 | |||
Low physical activity | −13.3 | ≤ .001 | 120 | −12.5 | ≤ .001 | 128 |