. | Control . | PREDIAS . | Between-group P-value . |
---|---|---|---|
BMI (kg/m2) | |||
Baseline | 32.0 ± 5.7 | 31.0 ± 4.7 | |
Endpoint | 31.5 ± 5.8 | 29.7 ± 4.7 | |
Change from baseline to endpoint | −0.5 ± 1.4 (P = 0.002)* | −1.3 ± 1.7 (P < 0.001)* | 0.002 |
Weight (kg) | |||
Baseline | 93.6 ± 19.3 | 92.1 ± 16.5 | |
Endpoint | 92.2 ± 19.4 | 88.3 ± 15.9 | |
Change from baseline to endpoint | −1.4 ± 4.0 (P = 0.002)* | −3.8 ± 5.2 (P < 0.001)* | 0.001 |
Waist circumference (cm) | |||
Baseline | 106.3 ± 13.7 | 106.8 ± 13.7 | |
Endpoint | 105.9 ± 14.1 | 102.7 ± 12.5 | |
Change from baseline to endpoint | −0.4 ± 6.2 (P = 0.559)* | −4.1 ± 6.0 (P < 0.001)* | 0.001 |
Fasting glucose (mg/dl) | |||
Baseline | 105.5 ± 12.4 | 105.7 ± 12.4 | |
Endpoint | 107.3 ± 14.3 | 101.4 ± 11.3 | |
Change from baseline to endpoint | 1.8 ± 13.1 (P = 0.211)* | −4.3 ± 11.3 (P = 0.001)* | 0.001 |
2-h postprandial OGTT (mg/dl) | |||
Baseline | 138.5 ± 34.9 | 133.1 ± 36.2 | |
Endpoint | 130.3 ± 36.1 | 125.8 ± 41.3 | |
Change from baseline to endpoint | −8.2 ± 36.9 (P = 0.060)* | −7.3 ± 30.8 (P = 0.041)* | 0.865 |
A1C (%) | |||
Baseline | 5.7 ± 0.6 | 5.7 ± 0.5 | |
Endpoint | 5.8 ± 0.5 | 5.7 ± 0.4 | |
Change from baseline to endpoint | 0.1 ± 0.4 (P = 0.165)* | 0.0 ± 0.3 (P = 0.203)* | 0.060 |
Physical exercise (min/week) | |||
Baseline | 96.9 ± 76.3 | 104.2 ± 80.24 | |
Endpoint | 114.0 ± 72.6 | 150.8 ± 75.18 | |
Change from baseline to endpoint | 17.9 ± 63.8 (P = 0.035)* | 46.6 ± 95.5 (P < 0.001)* | 0.034 |
Total cholesterol (mg/dl) | |||
Baseline | 209.9 ± 36.6 | 212.2 ± 43.8 | |
Endpoint | 207.9 ± 36.8 | 201.9 ± 35.6 | |
Change from baseline to endpoint | −2.0 ± 35.1 (P = 0.607)* | −10.3 ± 35.9 (P = 0.011)* | 0.144 |
HDL cholesterol (mg/dl) | |||
Baseline | 53.5 ± 13.2 | 55.9 ± 14.1 | |
Endpoint | 51.3 ± 14.5 | 54.6 ± 14.9 | |
Change from baseline to endpoint | −2.2 ± 9.4 (P = 0.044)* | −1.3 ± 6.9 (P = 0.104)* | 0.479 |
Triglycerides (mg/dl) | |||
Baseline | 144.1 ± 102.1 | 156.2 ± 151.0 | |
Endpoint | 141.6 ± 99.5 | 120.6 ± 65.5 | |
Change from baseline to endpoint | −2.5 ± 100.3 (P = 0.823)* | −35.6 ± 136.8 (P = 0.022)* | 0.087 |
Systolic blood pressure (mmHg) | |||
Baseline | 139.1 ± 15.9 | 141.8 ± 18.6 | |
Endpoint | 138.1 ± 15.3 | 137.2 ± 17.1 | |
Change from baseline to endpoint | −1.0 ± 16.7 (P = 0.610)* | −4.6 ± 19.1 (P = 0.035)* | 0.217 |
Diastolic blood pressure (mmHg) | |||
Baseline | 87.3 ± 9.7 | 88.5 ± 10.5 | |
Endpoint | 85.2 ± 12.3 | 84.1 ± 10.4 | |
Change from baseline to endpoint | −2.1 ± 12.6 (P = 0.151)* | −4.4 ± 11.7 (P = 0.001)* | 0.255 |
TFEQ | |||
Cognitive restraint | |||
Baseline | 10.2 ± 4.3 | 10.0 ± 4.0 | |
Endpoint | 11.7 ± 4.7 | 13.9 ± 4.2 | |
Change from baseline to endpoint | 1.5 ± 3.0 (P < 0.001)* | 3.9 ± 3.8 (P < 0.001)* | 0.0011 |
Disinhibition | |||
Baseline | 6.3 ± 3.9 | 6.1 ± 3.2 | |
Endpoint | 5.8 ± 3.9 | 4.9 ± 2.6 | |
Change from baseline to endpoint | −0.4 ± 2.6 (P = 0.247)* | −1.2 ± 2.7 (P < 0.001)* | 0.049 |
Hunger | |||
Baseline | 4.9 ± 3.8 | 4.5 ± 3.4 | |
Endpoint | 4.7 ± 3.8 | 3.4 ± 3.1 | |
Change from baseline to endpoint | −0.2 ± 2.7 (P = 0.434)* | −1.1 ± 3.1 (P = 0.002)* | 0.066 |
Psychological well-being by WHO-5 | |||
Baseline | 14.3 ± 4.9 | 15.3 ± 5.1 | |
Endpoint | 14.3 ± 5.1 | 16.7 ± 4.8 | |
Change from baseline to endpoint | 0.0 ± 4.2 (P = 0.901)* | 1.4 ± 3.9 (P = 0.015)* | 0.101 |
Depression by CES-D | |||
Baseline | 13.7 ± 8.2 | 12.0 ± 9.5 | |
Endpoint | 11.4 ± 7.8 | 9.8 ± 7.5 | |
Change from baseline to endpoint | −2.3 ± 6.8 (P = 0.009)* | −2.2 ± 7.7 (P = 0.031)* | 0.876 |
Trait Anxiety by STAI | |||
Baseline | 39.5 ± 9.8 | 38.5 ± 10.4 | |
Endpoint | 38.5 ± 9.5 | 34.5 ± 9.5 | |
Change from baseline to endpoint | −1.0 ± 6.1 (P = 0.142)* | −3.5 ± 7.1 (P = 0.001)* | 0.023 |
. | Control . | PREDIAS . | Between-group P-value . |
---|---|---|---|
BMI (kg/m2) | |||
Baseline | 32.0 ± 5.7 | 31.0 ± 4.7 | |
Endpoint | 31.5 ± 5.8 | 29.7 ± 4.7 | |
Change from baseline to endpoint | −0.5 ± 1.4 (P = 0.002)* | −1.3 ± 1.7 (P < 0.001)* | 0.002 |
Weight (kg) | |||
Baseline | 93.6 ± 19.3 | 92.1 ± 16.5 | |
Endpoint | 92.2 ± 19.4 | 88.3 ± 15.9 | |
Change from baseline to endpoint | −1.4 ± 4.0 (P = 0.002)* | −3.8 ± 5.2 (P < 0.001)* | 0.001 |
Waist circumference (cm) | |||
Baseline | 106.3 ± 13.7 | 106.8 ± 13.7 | |
Endpoint | 105.9 ± 14.1 | 102.7 ± 12.5 | |
Change from baseline to endpoint | −0.4 ± 6.2 (P = 0.559)* | −4.1 ± 6.0 (P < 0.001)* | 0.001 |
Fasting glucose (mg/dl) | |||
Baseline | 105.5 ± 12.4 | 105.7 ± 12.4 | |
Endpoint | 107.3 ± 14.3 | 101.4 ± 11.3 | |
Change from baseline to endpoint | 1.8 ± 13.1 (P = 0.211)* | −4.3 ± 11.3 (P = 0.001)* | 0.001 |
2-h postprandial OGTT (mg/dl) | |||
Baseline | 138.5 ± 34.9 | 133.1 ± 36.2 | |
Endpoint | 130.3 ± 36.1 | 125.8 ± 41.3 | |
Change from baseline to endpoint | −8.2 ± 36.9 (P = 0.060)* | −7.3 ± 30.8 (P = 0.041)* | 0.865 |
A1C (%) | |||
Baseline | 5.7 ± 0.6 | 5.7 ± 0.5 | |
Endpoint | 5.8 ± 0.5 | 5.7 ± 0.4 | |
Change from baseline to endpoint | 0.1 ± 0.4 (P = 0.165)* | 0.0 ± 0.3 (P = 0.203)* | 0.060 |
Physical exercise (min/week) | |||
Baseline | 96.9 ± 76.3 | 104.2 ± 80.24 | |
Endpoint | 114.0 ± 72.6 | 150.8 ± 75.18 | |
Change from baseline to endpoint | 17.9 ± 63.8 (P = 0.035)* | 46.6 ± 95.5 (P < 0.001)* | 0.034 |
Total cholesterol (mg/dl) | |||
Baseline | 209.9 ± 36.6 | 212.2 ± 43.8 | |
Endpoint | 207.9 ± 36.8 | 201.9 ± 35.6 | |
Change from baseline to endpoint | −2.0 ± 35.1 (P = 0.607)* | −10.3 ± 35.9 (P = 0.011)* | 0.144 |
HDL cholesterol (mg/dl) | |||
Baseline | 53.5 ± 13.2 | 55.9 ± 14.1 | |
Endpoint | 51.3 ± 14.5 | 54.6 ± 14.9 | |
Change from baseline to endpoint | −2.2 ± 9.4 (P = 0.044)* | −1.3 ± 6.9 (P = 0.104)* | 0.479 |
Triglycerides (mg/dl) | |||
Baseline | 144.1 ± 102.1 | 156.2 ± 151.0 | |
Endpoint | 141.6 ± 99.5 | 120.6 ± 65.5 | |
Change from baseline to endpoint | −2.5 ± 100.3 (P = 0.823)* | −35.6 ± 136.8 (P = 0.022)* | 0.087 |
Systolic blood pressure (mmHg) | |||
Baseline | 139.1 ± 15.9 | 141.8 ± 18.6 | |
Endpoint | 138.1 ± 15.3 | 137.2 ± 17.1 | |
Change from baseline to endpoint | −1.0 ± 16.7 (P = 0.610)* | −4.6 ± 19.1 (P = 0.035)* | 0.217 |
Diastolic blood pressure (mmHg) | |||
Baseline | 87.3 ± 9.7 | 88.5 ± 10.5 | |
Endpoint | 85.2 ± 12.3 | 84.1 ± 10.4 | |
Change from baseline to endpoint | −2.1 ± 12.6 (P = 0.151)* | −4.4 ± 11.7 (P = 0.001)* | 0.255 |
TFEQ | |||
Cognitive restraint | |||
Baseline | 10.2 ± 4.3 | 10.0 ± 4.0 | |
Endpoint | 11.7 ± 4.7 | 13.9 ± 4.2 | |
Change from baseline to endpoint | 1.5 ± 3.0 (P < 0.001)* | 3.9 ± 3.8 (P < 0.001)* | 0.0011 |
Disinhibition | |||
Baseline | 6.3 ± 3.9 | 6.1 ± 3.2 | |
Endpoint | 5.8 ± 3.9 | 4.9 ± 2.6 | |
Change from baseline to endpoint | −0.4 ± 2.6 (P = 0.247)* | −1.2 ± 2.7 (P < 0.001)* | 0.049 |
Hunger | |||
Baseline | 4.9 ± 3.8 | 4.5 ± 3.4 | |
Endpoint | 4.7 ± 3.8 | 3.4 ± 3.1 | |
Change from baseline to endpoint | −0.2 ± 2.7 (P = 0.434)* | −1.1 ± 3.1 (P = 0.002)* | 0.066 |
Psychological well-being by WHO-5 | |||
Baseline | 14.3 ± 4.9 | 15.3 ± 5.1 | |
Endpoint | 14.3 ± 5.1 | 16.7 ± 4.8 | |
Change from baseline to endpoint | 0.0 ± 4.2 (P = 0.901)* | 1.4 ± 3.9 (P = 0.015)* | 0.101 |
Depression by CES-D | |||
Baseline | 13.7 ± 8.2 | 12.0 ± 9.5 | |
Endpoint | 11.4 ± 7.8 | 9.8 ± 7.5 | |
Change from baseline to endpoint | −2.3 ± 6.8 (P = 0.009)* | −2.2 ± 7.7 (P = 0.031)* | 0.876 |
Trait Anxiety by STAI | |||
Baseline | 39.5 ± 9.8 | 38.5 ± 10.4 | |
Endpoint | 38.5 ± 9.5 | 34.5 ± 9.5 | |
Change from baseline to endpoint | −1.0 ± 6.1 (P = 0.142)* | −3.5 ± 7.1 (P = 0.001)* | 0.023 |
Data are means ± SD.
*P = within group test. OGGT, oral glucose tolerance test; STAI, State-Trait Anxiety Inventory; TFEQ, Three Factor Eating Questionnaire.