Change in physiological outcomes by diabetes status and race from baseline to 6, 12, and 24 months
| Outcome | n | Phase 1 | n | Phase 2 | n | Phase 3 |
|---|---|---|---|---|---|---|
| Baseline to 6 months | Baseline to 12 months | Baseline to 24 months | ||||
| Mean, 95% CI | Mean, 95% CI | Mean, 95% CI | ||||
| Systolic BP, mm Hg | 249 | −6.4 (−8.7 to −4.1)*** | 251 | −6.2 (−9.0 to −3.3)*** | 250 | −7.3 (−9.9 to −4.6)*** |
| Diabetes (all) | 93 | −7.1 (−11.3 to −3.0)*** | 97 | −5.8 (−10.9 to −0.6)* | 96 | −7.4 (−11.9 to −3.0)** |
| African-American | 67 | −8.6 (−13.9 to −3.2)** | 74 | −6.4 (−12.7 to −0.1)* | 74 | −9.3 (−14.6 to −4.0)*** |
| White | 25 | −3.8 (−9.6 to 2.0) | 22 | −4.1 (−13.2 to 5.0) | 21 | −0.4 (−8.7 to 8.0) |
| No diabetes (all) | 156 | −5.9 (−8.7 to −3.2)*** | 154 | −6.4 (−9.7 to −3.1)*** | 154 | −7.1 (−10.5 to −3.8)*** |
| African-American | 101 | −5.6 (−8.9 to −2.2)** | 102 | −7.3 (−11.6 to −3.1)*** | 103 | −7.9 (−12.2 to −3.5)*** |
| White | 53 | −6.5 (−11.3 to −1.7)** | 51 | −4.3 (−9.5 to 0.8) | 50 | −5.6 (−10.7 to −0.5)* |
| Diastolic BP, mm Hg | 249 | −3.7 (−4.9 to −2.5)*** | 251 | −5.0 (−6.4 to −3.6)*** | 250 | −6.7 (−8.3 to −5.2)*** |
| Diabetes (all) | 93 | −4.4 (−6.4 to −2.3)*** | 97 | −5.6 (−8.2 to −3.0)*** | 96 | −7.2 (−10.1 to −4.3)*** |
| African-American | 67 | −4.6 (−7.2 to −2.1)*** | 74 | −5.8 (−8.8 to −2.7)*** | 74 | −8.2 (−11.7 to −4.7)*** |
| White | 25 | −4.1 (−7.6 to −0.7)* | 22 | −4.7 (−10.0 to 0.6) | 21 | −3.3 (−8.3 to 1.7) |
| No diabetes (all) | 156 | −3.4 (−4.8 to −1.9)*** | 154 | −4.6 (−6.2 to −3.0)*** | 154 | −6.4 (−8.2 to −4.7)*** |
| African-American | 101 | −2.8 (−4.8 to −0.9)** | 102 | −4.8 (−7.0 to −2.7)*** | 103 | −6.5 (−8.9 to −4.0)*** |
| White | 53 | −4.3 (−6.5 to −2.1)*** | 51 | −3.9 (−6.2 to −1.6)*** | 50 | −6.3 (−8.5 to −4.1)*** |
| Weight, kg | 248 | −0.7 (−1.2 to −0.3)** | 250 | −1.7 (−2.5 to −1.0)*** | 247 | −1.6 (−2.5 to −0.8)*** |
| Diabetes (all) | 92 | −1.2 (−2.1 to −0.4)** | 96 | −1.5 (−2.9 to −0.2)* | 93 | −3.7 (−5.2 to −2.1)*** |
| African-American | 66 | −1.1 (−2.0 to −0.3)** | 73 | −1.0 (−2.5 to 0.4) | 71 | −3.1 (−4.6 to −1.5)*** |
| White | 25 | −1.6 (−4.0 to 0.7) | 22 | −3.3 (−6.9 to 0.4) | 21 | −5.5 (−9.9 to −1.2)* |
| No diabetes (all) | 156 | −0.4 (−0.9 to 0.1) | 154 | −1.8 (−2.7 to −1.0)*** | 154 | −0.4 (−1.4 to 0.6) |
| African-American | 101 | −0.7 (−1.4 to 0.0) | 102 | −2.2 (−3.4 to −1.1)*** | 103 | −0.9 (−2.2 to 0.4) |
| White | 53 | 0.2 (−0.5 to 0.8) | 51 | −1.0 (−2.3 to 0.4) | 50 | 0.9 (−0.8 to 2.5) |
| ≥5% weight loss, % | 248 | 9.3 (5.6 to 12.9) | 250 | 23.2 (17.9 to 28.5) | 247 | 23.1 (17.8 to 28.4) |
| Diabetes (all) | 92 | 10.9 (4.5 to 17.3) | 96 | 20.8 (12.7 to 29) | 93 | 34.4 (24.7 to 44.1) |
| African-American | 66 | 12.1 (4.1 to 20.2) | 73 | 19.2 (10.0 to 28.4) | 71 | 32.4 (21.3 to 43.5) |
| White | 25 | 8.0 (0.0 to 18.8) | 22 | 27.3 (8.3 to 46.2) | 21 | 38.1 (16.9 to 59.3) |
| No diabetes (all) | 156 | 8.3 (4.0 to 12.7) | 154 | 24.7 (17.8 to 31.5) | 154 | 16.2 (10.4 to 22.1) |
| African-American | 101 | 11.9 (5.5 to 18.3) | 102 | 26.5 (17.8 to 35.1) | 103 | 18.5 (10.9 to 26.0) |
| White | 53 | 1.9 (0.0 to 5.6) | 51 | 19.6 (8.6 to 30.6) | 50 | 10.0 (1.6 to 18.4) |
| HbA1c, %† | 217 | 0.01 (−0.09 to 0.12) | 220 | −0.07 (−0.20 to 0.06) | ||
| Diabetes (all) | 80 | −0.11 (−0.38 to 0.17) | 84 | −0.30 (−0.63 to 0.02) | ||
| African-American | 60 | −0.10 (−0.45 to 0.25) | 66 | −0.33 (−0.72 to 0.06) | ||
| White | 19 | −0.20 (−0.60 to 0.20) | 17 | −0.28 (−0.85 to 0.28) | ||
| No diabetes (all) | 137 | 0.08 (0.04 to 0.11)*** | 136 | 0.07 (0.01 to 0.13)* | ||
| African-American | 87 | 0.10 (0.05 to 0.14)*** | 88 | 0.08 (0.01 to 0.16)* | ||
| White | 48 | 0.05 (0.00 to 0.10) | 47 | 0.05 (−0.03 to 0.13) | ||
| HbA1c, mmol/mol† | 217 | 0.1 (−1.0 to 1.3) | 220 | −0.8 (−2.2 to 0.7) | ||
| Diabetes (all) | 80 | −1.2 (−4.2 to 1.9) | 84 | −3.3 (−6.9 to 0.2) | ||
| African-American | 60 | −1.1 (−4.9 to 2.7) | 66 | −3.6 (−7.9 to 0.7) | ||
| White | 19 | −2.2 (−6.6 to 2.2) | 17 | −3.1 (−9.3 to 3.1) | ||
| No diabetes (all) | 137 | 0.9 (0.4 to 1.2)*** | 136 | 0.8 (0.1 to 1.4)* | ||
| African-American | 87 | 1.1 (0.5 to 1.5)*** | 88 | 0.9 (0.1 to 1.7)* | ||
| White | 48 | 0.5 (0.0 to 1.1) | 47 | 0.5 (−0.3 to 1.4) | ||
| Total cholesterol, mg/dL‡ | 221 | −3.2 (−7.0 to 0.7) | 211 | −3.1 (−7.8 to 1.7) | ||
| Diabetes (all) | 84 | 0.4 (−6.7 to 7.6) | 83 | −4.2 (−13.1 to 4.6) | ||
| African-American | 66 | −0.4 (−8.3 to 7.6) | 65 | −7.1 (−17.5 to 3.4) | ||
| White | 17 | 6.9 (−9.5 to 23.3) | 17 | 9.1 (−6.6 to 24.8) | ||
| No diabetes (all) | 137 | −5.4 (−9.8 to −1.1)* | 128 | −2.3 (−7.7 to 3.0) | ||
| African-American | 89 | −6.8 (−11.8 to −1.8)** | 83 | −2.4 (−8.9 to 4.2) | ||
| White | 47 | −2.5 (−11.0 to 6.0) | 44 | −2.2 (−11.6 to 7.2) | ||
| HDL cholesterol, mg/dL‡ | 220 | −1.6 (−2.8 to −0.4)* | 211 | −1.0 (−2.3 to 0.3) | ||
| Diabetes (all) | 84 | −2.0 (−4.0 to 0.0)* | 83 | −2.1 (−4.4 to 0.3) | ||
| African-American | 66 | −1.4 (−3.7 to 0.8) | 65 | −2.2 (−4.8 to 0.5) | ||
| White | 17 | −3.9 (−8.7 to 0.8) | 17 | −1.8 (−7.6 to 4.0) | ||
| No diabetes (all) | 136 | −1.3 (−2.8 to 0.2) | 128 | −0.3 (−1.7 to 1.2) | ||
| African-American | 88 | −1.6 (−3.6 to 0.4) | 83 | −0.1 (−2.1 to 2.0) | ||
| White | 47 | −0.9 (−3.1 to 1.2) | 44 | −0.6 (−2.6 to 1.3) |
Significance level:
*p<0.05; **p<0.01; ***p<0.001.
†HbA1c was not measured at 24 months.
‡Lipids were not measured at 6 months.
BP, blood pressure; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein.