Table 1

Baseline and 12-month follow-up results in the control group and the PREDIAS group

ControlPREDIASBetween-group P-value
BMI (kg/m2)
    Baseline32.0 ± 5.731.0 ± 4.7
    Endpoint31.5 ± 5.829.7 ± 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)
    Baseline93.6 ± 19.392.1 ± 16.5
    Endpoint92.2 ± 19.488.3 ± 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)
    Baseline106.3 ± 13.7106.8 ± 13.7
    Endpoint105.9 ± 14.1102.7 ± 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)
    Baseline105.5 ± 12.4105.7 ± 12.4
    Endpoint107.3 ± 14.3101.4 ± 11.3
    Change from baseline to endpoint1.8 ± 13.1 (P = 0.211)*−4.3 ± 11.3 (P = 0.001)*0.001
2-h postprandial OGTT (mg/dl)
    Baseline138.5 ± 34.9133.1 ± 36.2
    Endpoint130.3 ± 36.1125.8 ± 41.3
    Change from baseline to endpoint−8.2 ± 36.9 (P = 0.060)*−7.3 ± 30.8 (P = 0.041)*0.865
A1C (%)
    Baseline5.7 ± 0.65.7 ± 0.5
    Endpoint5.8 ± 0.55.7 ± 0.4
    Change from baseline to endpoint0.1 ± 0.4 (P = 0.165)*0.0 ± 0.3 (P = 0.203)*0.060
Physical exercise (min/week)
    Baseline96.9 ± 76.3104.2 ± 80.24
    Endpoint114.0 ± 72.6150.8 ± 75.18
    Change from baseline to endpoint17.9 ± 63.8 (P = 0.035)*46.6 ± 95.5 (P < 0.001)*0.034
Total cholesterol (mg/dl)
    Baseline209.9 ± 36.6212.2 ± 43.8
    Endpoint207.9 ± 36.8201.9 ± 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)
    Baseline53.5 ± 13.255.9 ± 14.1
    Endpoint51.3 ± 14.554.6 ± 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)
    Baseline144.1 ± 102.1156.2 ± 151.0
    Endpoint141.6 ± 99.5120.6 ± 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)
    Baseline139.1 ± 15.9141.8 ± 18.6
    Endpoint138.1 ± 15.3137.2 ± 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)
    Baseline87.3 ± 9.788.5 ± 10.5
    Endpoint85.2 ± 12.384.1 ± 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
        Baseline10.2 ± 4.310.0 ± 4.0
        Endpoint11.7 ± 4.713.9 ± 4.2
        Change from baseline to endpoint1.5 ± 3.0 (P < 0.001)*3.9 ± 3.8 (P < 0.001)*0.0011
    Disinhibition
        Baseline6.3 ± 3.96.1 ± 3.2
        Endpoint5.8 ± 3.94.9 ± 2.6
        Change from baseline to endpoint−0.4 ± 2.6 (P = 0.247)*−1.2 ± 2.7 (P < 0.001)*0.049
    Hunger
        Baseline4.9 ± 3.84.5 ± 3.4
        Endpoint4.7 ± 3.83.4 ± 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
    Baseline14.3 ± 4.915.3 ± 5.1
    Endpoint14.3 ± 5.116.7 ± 4.8
    Change from baseline to endpoint0.0 ± 4.2 (P = 0.901)*1.4 ± 3.9 (P = 0.015)*0.101
Depression by CES-D
    Baseline13.7 ± 8.212.0 ± 9.5
    Endpoint11.4 ± 7.89.8 ± 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
    Baseline39.5 ± 9.838.5 ± 10.4
    Endpoint38.5 ± 9.534.5 ± 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.