Table 1.
Participants’ characteristics at the immediate post-intervention assessment (a mean of 10.2 years post-randomization).
| Overall N=3288 | ILI N=1646 | DSE N=1642 | P-value | |
|---|---|---|---|---|
| Gender, No. (%) | 0.35 | |||
| Male | 1314 (40.0%) | 671 (40.8%) | 643 (39.2%) | |
| Female | 1974 (60.0%) | 975 (59.2%) | 999 (60.8%) | |
| Race/Ethnicity, No. (%) | 0.69 | |||
| African American/Black | 530 (16.1%) | 251 (15.2%) | 279 (17.0%) | |
| Hispanic | 416 (12.7%) | 206 (12.5%) | 210 (12.8%) | |
| White | 2033 (61.8%) | 1032 (62.7%) | 1001 (61.0%) | |
| American Indian/Native American/ Alaskan Native | 206 (6.3%) | 103 (6.3%) | 103 (6.3%) | |
| Other/Mixed | 103 (3.1%) | 54 (3.3%) | 49 (3.0%) | |
| Cardiovascular history, No. (%)a | 0.21 | |||
| Yes | 410 (12.5%) | 217 (13.2%) | 193 (11.8%) | |
| No | 2878 (87.5%) | 1429 (86.8%) | 1449 (88.2%) | |
| Insulin use, No. (%)a | 0.92 | |||
| Yes | 473 (14.9%) | 236 (14.9%) | 237 (15.0%) | |
| No | 2697 (85.1%) | 1352 (85.1%) | 1345 (85.0%) | |
| Age, mean ± SD, years | 69.54 ± 6.5 | 69.37 ± 6.5 | 69.70 ± 6.59 | 0.15 |
| Diabetes duration, mean ± SD, years | 16.90 ± 6.5 | 16.90 ± 6.6 | 16.91 ± 6.31 | 0.98 |
| Weight, mean ± SD, kg | 94.69 ± 19.3 | 93.24 ± 19.2 | 96.14 ± 19.23 | <.001 |
| BMI, mean ± SD, kg/m2 | 33.92 ± 6.1 | 33.38 ± 6.0 | 34.46 ± 6.05 | <.001 |
| HbA1c, mean ± SD, % | 7.38 ± 1.5 | 7.35 ± 1.5 | 7.41 ± 1.54 | 0.54 |
| PHQ-9 score, mean ± SDb | 2.65 ± 3.5 | 2.65 ± 3.5 | 2.65 ± 3.43 | 0.96 |
| PHQ-9 category, No. (%)b | 0.58 | |||
| 0–4 no or minimal symptoms | 2781 (79.8%) | 1398 (79.5%) | 1383 (80.0%) | |
| 5–9 mild symptoms | 540 (15.5%) | 271 (15.4%) | 269 (15.6%) | |
| 10–14 moderate | 105 (3.0%) | 60 (3.4%) | 45 (2.6%) | |
| 15–19 moderately severe or >20 severe | 61 (1.7%) | 30 (1.7%) | 31 (1.8%) | |
| History of depression, No. (%)a | 0.53 | |||
| Yes | 637 (19.4%) | 326 (19.8%) | 311 (19.0%) | |
| No | 2649 (80.6%) | 1319 (80.2%) | 1330 (81.0%) | |
| Antidepressant use, No. (%) | 0.88 | |||
| Yes | 669 (23.5%) | 338 (23.6%) | 331 (23.4%) | |
| No | 2176 (76.5%) | 1092 (76.4%) | 1084 (76.6%) | |
| SF-36, MCS score, mean ± SD | 54.28 ± 9.3 | 54.17 ± 9.3 | 54.39 ± 9.30 | 0.51 |
| SF-36, PCS score, mean ± SD | 43.50 ± 10.2 | 43.84 ± 10.2 | 43.16 ± 10.21 | 0.06 |
Note. Values are from post-intervention assessment unless otherwise indicated.
a
Values are from randomization.
b
Values are from the Continuation visit.
BMI = body mass index. PHQ-9 = Patient Health Questionnaire-9. SF-36 = Short-Form 36. MCS = mental component summary; PCS = physical component summary.