Table 2. Change in primary and secondary outcomes at month 6.
| Measure | PCD | DSME | P-value |
|---|---|---|---|
| N, baseline (6 months) | 50 (49) | 50 (50) | |
| Weight (kg) | |||
| Baseline | 101.8±16.7 | 104.0±20.1 | |
| 6 Months | 93.9±14.7 | 101.8±19.4 | |
| Adjusted change | −7.3 (−8.8 to −5.8) | −2.2 (−3.7 to −0.7) | <0.0001 |
| Body mass index (kg m−2) | |||
| Baseline | 35.3±4.6 | 36.2±5.8 | |
| 6 Months | 32.6±4.2 | 35.5±5.8 | |
| Adjusted change | −2.5 (−3.0 to −2.0) | −0.7 (−1.2 to −0.2) | <0.0001 |
| Waist circumference (cm) | |||
| Baseline | 115.9±12.1 | 118.4±14.8 | |
| 6 Months | 108.9±11.1 | 115.5±14.9 | |
| Adjusted change | −6.5 (−7.8 to −5.3) | −2.9 (−4.1 to −1.7) | <0.0001 |
| Hemoglobin A1C(%) | |||
| Baseline | 7.6±1.3 | 7.9±1.3 | |
| 6 Months | 6.9±1.2 | 7.5±1.3 | |
| Adjusted change | −0.7 (−1.0 to −0.4) | −0.4 (−0.7 to −0.1) | 0.021 |
| Fasting glucose (mg dl−1) | |||
| Baseline | 144.2±44.9 | 161.5±59.9 | |
| 6 Months | 128.0±47.9 | 148.7±52.3 | |
| Adjusted change | −16.5 (−33.0 to +0.1) | −12.8 (−29.3 to +3.7) | 0.217a |
| Systolic blood pressure (mm Hg) | |||
| Baseline | 128.2±16.6 | 125.7±17.3 | |
| 6 Months | 121.4±16.2 | 123.8±13.8 | |
| Adjusted change | −6.6 (−11.0 to −2.2) | −1.9 (−6.2 to +2.5) | 0.044a |
| Diastolic blood pressure (mm Hg) | |||
| Baseline | 74.4±9.5 | 75.4±10.4 | |
| 6 Months | 72.4±11.2 | 74.1±9.8 | |
| Adjusted change | −2.2 (−4.6 to +3.0) | −1.2 (−3.6 to +1.2) | 0.359 |
| Triglycerides (mg dl−1) | |||
| Baseline | 136.5±60.7 | 141.0±78.5 | |
| 6 Months | 109.2±64.6 | 120.7±54.6 | |
| Adjusted change | −26.3 (−42.4 to −10.3) | −20.3 (−36.3 to −4.3) | 0.343a |
| Total cholesterol (mg dl−1) | |||
| Baseline | 172.3±39.8 | 173.1±38.0 | |
| 6 Months | 162.5±42.2 | 165.3±29.6 | |
| Adjusted change | −8.6 (−15.9 to −1.2) | −7.8 (−15.1 to −0.5) | 0.808 |
| High-density lipoprotein (mg dl−1) | |||
| Baseline | 49.9±16.8 | 51.8±15.3 | |
| 6 Months | 50.1±14.8 | 50.2±13.8 | |
| Adjusted change | −0.1 (−1.9 to +1.7) | −1.6 (−3.4 to +0.2) | 0.113 |
| Low-density lipoprotein (mg dl−1) | |||
| Baseline | 96.0±36.4 | 94.3±30.5b | |
| 6 Months | 90.3±36.1 | 93.0±26.6 | |
| Adjusted change | −4.3 (−11.0 to +2.4) | −0.8 (−7.6 to +5.9) | 0.320 |
| hs-CRP (mg l−1) | |||
| Baseline | 5.6±7.4b | 5.8±6.0 | |
| 6 Months | 4.4±5.8 | 4.7±4.8 | |
| Adjusted change | −1.0 (−2.5 to +0.5) | −1.2 (−2.6 to 0.3) | 0.883 |
Abbreviations: DSME, diabetes self-management education program; hs-CRP, high-sensitivity CRP; PCD, portion-controlled diet
a
Indicates that P-values were obtained from a linear mixed-effects model on the log-transformed outcome, which were similar in direction and significance to analyses performed on the raw outcome.
b
Data were obtained for only 49 of 50 participants.
Unadjusted baseline and 6-month data are reported as means±s.d.
Adjusted change is reported as means (95% confidence intervals) and was obtained from linear mixed-effects models with time, treatment, and a time by treatment interaction included as explanatory variables.