Participant characteristics at randomization according to quintile of HbA1c (Look AHEAD)
| Characteristicsa . | Quintile 1 . | Quintile 2 . | Quintile 3 . | Quintile 4 . | Quintile 5 . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c %, range | 4.4-6.3 | 6.4-6.8 | 6.9-7.3 | 7.3-8.1 | 8.2-14.5 | |||||
| Intervention arm | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE |
| n (% total of quintile) | 591 (53) | 524 (47) | 497 (49) | 515 (51) | 476 (48) | 516 (52) | 516 (51) | 500 (49) | 490 (49) | 520 (51) |
| HbA1c %, mean (SD) | 6.0 (0.3) | 5.9 (0.3) | 6.6 (0.1) | 6.6 (0.1) | 7.1 (0.1) | 7.1 (0.1) | 7.7 (0.2) | 7.7 (0.2) | 9.1 (0.8) | 9.2 (0.9) |
| Female, n (%) | 332 (56) | 316 (60) | 298 (60) | 312 (61) | 284 (60) | 311 (60) | 310 (60) | 293 (59) | 302 (62) | 305 (59) |
| Age, years (SD) | 59 (7) | 59 (7) | 59 (7) | 60 (7) | 59 (7) | 59 (7) | 58 (7) | 59 (7) | 57 (7) | 57 (7) |
| Race/ethnicity, n (%) | ||||||||||
| White | 397 (67) | 351 (67) | 343 (69) | 350 (68) | 301 (63) | 341 (66) | 318 (62) | 312 (62) | 262 (53) | 277 (53) |
| Black | 78 (13) | 67 (13) | 76 (15) | 67 (13) | 74 (16) | 74 (14) | 82 (16) | 89 (18) | 90 (18) | 107 (21) |
| Native American/American Indian/Alaska Native | 31 (5) | 23 (4) | 19 (4) | 17 (3) | 24 (5) | 33 (6) | 21 (4) | 21 (4) | 35 (7) | 34 (7) |
| Asian/Pacific Islander | 10 (2) | 3 (1) | 3 (1) | 7 (1) | 5 (1) | 4 (1) | 6 (1) | 1 (0) | 5 (1) | 6 (1) |
| Hispanic | 62 (10) | 68 (13) | 49 (10) | 61 (12) | 60 (13) | 55 (11) | 77 (15) | 66 (13) | 92 (19) | 90 (17) |
| Other/multiple | 13 (2) | 12 (2) | 7 (1) | 13 (3) | 12 (3) | 9 (2) | 12 (2) | 11 (2) | 6 (1) | 6 (1) |
| Education >16 years, n (%) | 279 (47) | 221 (42) | 215 (43) | 228 (44) | 195 (41) | 215 (42) | 202 (39) | 199 (40) | 192 (39) | 191 (37) |
| Current smoker, n (%) | 23 (4) | 17 (3) | 17 (3) | 17 (3) | 22 (5) | 23 (4) | 21 (4) | 25 (5) | 34 (7) | 28 (5) |
| No regular alcohol consumption, n (%) | 382 (65) | 354 (68) | 336 (68) | 338 (66) | 320 (67) | 318 (62) | 370 (72) | 360 (72) | 343 (70) | 374 (72) |
| Exercise test fitness, Mets, median (IQR) | 7.4 (6.1, 9.0) | 7.1 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.4) | 7.0 (5.7, 8.5) | 6.8 (5.6, 8.0) | 6.7 (5.6, 8.0) | 6.6 (5.6, 8) | 6.7 (5.7, 8.0) |
| Physical activity,b kcal/week, median (IQR) | 420 (84, 1254) | 560 (140, 1300) | 502 (92, 176) | 448 (112, 1236) | 616 (196, 1344) | 560 (168, 1344) | 462 (112, 1064) | 574 (140, 1216) | 504 (112, 1236) | 364 (84, 908) |
| Duration of diabetes, years, median (IQR) | 2 (1, 6) | 3 (1, 6) | 4 (1, 8) | 4 (2, 8) | 5 (2, 10) | 5 (3, 9) | 6 (3, 11) | 6 (3, 11) | 7 (4, 12) | 7 (4, 12) |
| Family history of diabetes, n (%) | 340 (58) | 353 (67) | 323 (65) | 325 (63) | 303 (64) | 338 (66) | 336 (65) | 325 (65) | 321 (66) | 383 (74) |
| Diabetes medication—any use, n (%) | 444 (75) | 406 (77) | 426 (86) | 440 (85) | 419 (88) | 458 (89) | 480 (93) | 456 (91) | 473 (97) | 502 (97) |
| Metformin use, n (%) | 307 (52) | 259 (49) | 303 (61) | 310 (60) | 304 (64) | 307 (59) | 345 (67) | 329 (66) | 313 (64) | 343 (66) |
| Sulfonylurea use, n (%) | 192 (32) | 162 (31) | 198 (40) | 203 (39) | 226 (47) | 262 (51) | 277 (54) | 253 (51) | 272 (56) | 287 (55) |
| Thiazolidinedione use, n (%) | 123 (21) | 134 (26) | 117 (24) | 131 (25) | 125 (26) | 134 (26) | 132 (26) | 144 (29) | 145 (30) | 142 (27) |
| Insulin use, n (%) | 23 (4) | 28 (5) | 47 (9) | 46 (9) | 67 (14) | 81 (16) | 100 (19) | 94 (19) | 148 (30) | 161 (31) |
| Number of diabetes medications, mean (SD) | 1.1 (0.9) | 1.1 (0.9) | 1.4 (0.9) | 1.3 (0.9) | 1.6 (1.0) | 1.5 (1.0) | 1.7 (0.9) | 1.7 (1.0) | 1.9 (0.9) | 1.9 (1.0) |
| Body mass index, kg/m2 (SD) | 35 (6) | 36 (5) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 37 (6) | 37 (6) |
| SBP, mm Hg (SD) | 126 (17) | 127 (17) | 128 (17) | 130 (17) | 128 (17) | 130 (18) | 130 (18) | 129 (17) | 130 (18) | 131 (17) |
| DBP, mm Hg (SD) | 70 (9) | 69 (9) | 70 (10) | 70 (10) | 70 (9) | 71 (10) | 70 (10) | 70 (10) | 71 (10) | 72 (10) |
| Hypertension medication use, n (%) | 430 (73) | 385 (73) | 383 (77) | 367 (71) | 367 (77) | 378 (73) | 386 (75) | 377 (75) | 348 (71) | 370 (71) |
| LDL cholesterol, mg/dL (SD) | 112 (31) | 112 (29) | 110 (31) | 111 (31) | 112 (31) | 111 (31) | 112 (30) | 111 (31) | 117 (33) | 117 (33) |
| HDL cholesterol, mg/dL (SD) | 44 (12) | 45 (12) | 44 (12) | 44 (12) | 44 (12) | 43 (11) | 43 (12) | 43 (12) | 42 (11) | 42 (12) |
| Cholesterol medication use, n (%) | 285 (48) | 259 (49) | 264 (53) | 278 (54) | 258 (54) | 273 (53) | 261 (51) | 277 (55) | 238 (49) | 233 (45) |
| Prior history of CVD, n (%) | 66 (11) | 59 (11) | 75 (15) | 59 (11) | 63 (13) | 74 (14) | 87 (17) | 81 (16) | 74 (15) | 74 (14) |
| Characteristicsa . | Quintile 1 . | Quintile 2 . | Quintile 3 . | Quintile 4 . | Quintile 5 . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c %, range | 4.4-6.3 | 6.4-6.8 | 6.9-7.3 | 7.3-8.1 | 8.2-14.5 | |||||
| Intervention arm | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE |
| n (% total of quintile) | 591 (53) | 524 (47) | 497 (49) | 515 (51) | 476 (48) | 516 (52) | 516 (51) | 500 (49) | 490 (49) | 520 (51) |
| HbA1c %, mean (SD) | 6.0 (0.3) | 5.9 (0.3) | 6.6 (0.1) | 6.6 (0.1) | 7.1 (0.1) | 7.1 (0.1) | 7.7 (0.2) | 7.7 (0.2) | 9.1 (0.8) | 9.2 (0.9) |
| Female, n (%) | 332 (56) | 316 (60) | 298 (60) | 312 (61) | 284 (60) | 311 (60) | 310 (60) | 293 (59) | 302 (62) | 305 (59) |
| Age, years (SD) | 59 (7) | 59 (7) | 59 (7) | 60 (7) | 59 (7) | 59 (7) | 58 (7) | 59 (7) | 57 (7) | 57 (7) |
| Race/ethnicity, n (%) | ||||||||||
| White | 397 (67) | 351 (67) | 343 (69) | 350 (68) | 301 (63) | 341 (66) | 318 (62) | 312 (62) | 262 (53) | 277 (53) |
| Black | 78 (13) | 67 (13) | 76 (15) | 67 (13) | 74 (16) | 74 (14) | 82 (16) | 89 (18) | 90 (18) | 107 (21) |
| Native American/American Indian/Alaska Native | 31 (5) | 23 (4) | 19 (4) | 17 (3) | 24 (5) | 33 (6) | 21 (4) | 21 (4) | 35 (7) | 34 (7) |
| Asian/Pacific Islander | 10 (2) | 3 (1) | 3 (1) | 7 (1) | 5 (1) | 4 (1) | 6 (1) | 1 (0) | 5 (1) | 6 (1) |
| Hispanic | 62 (10) | 68 (13) | 49 (10) | 61 (12) | 60 (13) | 55 (11) | 77 (15) | 66 (13) | 92 (19) | 90 (17) |
| Other/multiple | 13 (2) | 12 (2) | 7 (1) | 13 (3) | 12 (3) | 9 (2) | 12 (2) | 11 (2) | 6 (1) | 6 (1) |
| Education >16 years, n (%) | 279 (47) | 221 (42) | 215 (43) | 228 (44) | 195 (41) | 215 (42) | 202 (39) | 199 (40) | 192 (39) | 191 (37) |
| Current smoker, n (%) | 23 (4) | 17 (3) | 17 (3) | 17 (3) | 22 (5) | 23 (4) | 21 (4) | 25 (5) | 34 (7) | 28 (5) |
| No regular alcohol consumption, n (%) | 382 (65) | 354 (68) | 336 (68) | 338 (66) | 320 (67) | 318 (62) | 370 (72) | 360 (72) | 343 (70) | 374 (72) |
| Exercise test fitness, Mets, median (IQR) | 7.4 (6.1, 9.0) | 7.1 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.4) | 7.0 (5.7, 8.5) | 6.8 (5.6, 8.0) | 6.7 (5.6, 8.0) | 6.6 (5.6, 8) | 6.7 (5.7, 8.0) |
| Physical activity,b kcal/week, median (IQR) | 420 (84, 1254) | 560 (140, 1300) | 502 (92, 176) | 448 (112, 1236) | 616 (196, 1344) | 560 (168, 1344) | 462 (112, 1064) | 574 (140, 1216) | 504 (112, 1236) | 364 (84, 908) |
| Duration of diabetes, years, median (IQR) | 2 (1, 6) | 3 (1, 6) | 4 (1, 8) | 4 (2, 8) | 5 (2, 10) | 5 (3, 9) | 6 (3, 11) | 6 (3, 11) | 7 (4, 12) | 7 (4, 12) |
| Family history of diabetes, n (%) | 340 (58) | 353 (67) | 323 (65) | 325 (63) | 303 (64) | 338 (66) | 336 (65) | 325 (65) | 321 (66) | 383 (74) |
| Diabetes medication—any use, n (%) | 444 (75) | 406 (77) | 426 (86) | 440 (85) | 419 (88) | 458 (89) | 480 (93) | 456 (91) | 473 (97) | 502 (97) |
| Metformin use, n (%) | 307 (52) | 259 (49) | 303 (61) | 310 (60) | 304 (64) | 307 (59) | 345 (67) | 329 (66) | 313 (64) | 343 (66) |
| Sulfonylurea use, n (%) | 192 (32) | 162 (31) | 198 (40) | 203 (39) | 226 (47) | 262 (51) | 277 (54) | 253 (51) | 272 (56) | 287 (55) |
| Thiazolidinedione use, n (%) | 123 (21) | 134 (26) | 117 (24) | 131 (25) | 125 (26) | 134 (26) | 132 (26) | 144 (29) | 145 (30) | 142 (27) |
| Insulin use, n (%) | 23 (4) | 28 (5) | 47 (9) | 46 (9) | 67 (14) | 81 (16) | 100 (19) | 94 (19) | 148 (30) | 161 (31) |
| Number of diabetes medications, mean (SD) | 1.1 (0.9) | 1.1 (0.9) | 1.4 (0.9) | 1.3 (0.9) | 1.6 (1.0) | 1.5 (1.0) | 1.7 (0.9) | 1.7 (1.0) | 1.9 (0.9) | 1.9 (1.0) |
| Body mass index, kg/m2 (SD) | 35 (6) | 36 (5) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 37 (6) | 37 (6) |
| SBP, mm Hg (SD) | 126 (17) | 127 (17) | 128 (17) | 130 (17) | 128 (17) | 130 (18) | 130 (18) | 129 (17) | 130 (18) | 131 (17) |
| DBP, mm Hg (SD) | 70 (9) | 69 (9) | 70 (10) | 70 (10) | 70 (9) | 71 (10) | 70 (10) | 70 (10) | 71 (10) | 72 (10) |
| Hypertension medication use, n (%) | 430 (73) | 385 (73) | 383 (77) | 367 (71) | 367 (77) | 378 (73) | 386 (75) | 377 (75) | 348 (71) | 370 (71) |
| LDL cholesterol, mg/dL (SD) | 112 (31) | 112 (29) | 110 (31) | 111 (31) | 112 (31) | 111 (31) | 112 (30) | 111 (31) | 117 (33) | 117 (33) |
| HDL cholesterol, mg/dL (SD) | 44 (12) | 45 (12) | 44 (12) | 44 (12) | 44 (12) | 43 (11) | 43 (12) | 43 (12) | 42 (11) | 42 (12) |
| Cholesterol medication use, n (%) | 285 (48) | 259 (49) | 264 (53) | 278 (54) | 258 (54) | 273 (53) | 261 (51) | 277 (55) | 238 (49) | 233 (45) |
| Prior history of CVD, n (%) | 66 (11) | 59 (11) | 75 (15) | 59 (11) | 63 (13) | 74 (14) | 87 (17) | 81 (16) | 74 (15) | 74 (14) |
Abbreviations: BMI, body mass index; CVD, cardiovascular disease; DBP, diastolic blood pressure; DSE, diabetes support and education; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; ILI, intensive lifestyle intervention; IQR, interquartile range; kcal, kilo-calories; LDL, low-density lipoprotein; Mets, metabolic equivalents; mm Hg, millimeters mercury; SBP, systolic blood pressure.
aValues are means (SD) or counts (column percentage) except when noted for “range” and “median (IQR).”
bPaffenbarger physical activity questionnaire data was missing for 53% of the sample, similar missing data percentage by randomization arm within HbA1c quintile.
Participant characteristics at randomization according to quintile of HbA1c (Look AHEAD)
| Characteristicsa . | Quintile 1 . | Quintile 2 . | Quintile 3 . | Quintile 4 . | Quintile 5 . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c %, range | 4.4-6.3 | 6.4-6.8 | 6.9-7.3 | 7.3-8.1 | 8.2-14.5 | |||||
| Intervention arm | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE |
| n (% total of quintile) | 591 (53) | 524 (47) | 497 (49) | 515 (51) | 476 (48) | 516 (52) | 516 (51) | 500 (49) | 490 (49) | 520 (51) |
| HbA1c %, mean (SD) | 6.0 (0.3) | 5.9 (0.3) | 6.6 (0.1) | 6.6 (0.1) | 7.1 (0.1) | 7.1 (0.1) | 7.7 (0.2) | 7.7 (0.2) | 9.1 (0.8) | 9.2 (0.9) |
| Female, n (%) | 332 (56) | 316 (60) | 298 (60) | 312 (61) | 284 (60) | 311 (60) | 310 (60) | 293 (59) | 302 (62) | 305 (59) |
| Age, years (SD) | 59 (7) | 59 (7) | 59 (7) | 60 (7) | 59 (7) | 59 (7) | 58 (7) | 59 (7) | 57 (7) | 57 (7) |
| Race/ethnicity, n (%) | ||||||||||
| White | 397 (67) | 351 (67) | 343 (69) | 350 (68) | 301 (63) | 341 (66) | 318 (62) | 312 (62) | 262 (53) | 277 (53) |
| Black | 78 (13) | 67 (13) | 76 (15) | 67 (13) | 74 (16) | 74 (14) | 82 (16) | 89 (18) | 90 (18) | 107 (21) |
| Native American/American Indian/Alaska Native | 31 (5) | 23 (4) | 19 (4) | 17 (3) | 24 (5) | 33 (6) | 21 (4) | 21 (4) | 35 (7) | 34 (7) |
| Asian/Pacific Islander | 10 (2) | 3 (1) | 3 (1) | 7 (1) | 5 (1) | 4 (1) | 6 (1) | 1 (0) | 5 (1) | 6 (1) |
| Hispanic | 62 (10) | 68 (13) | 49 (10) | 61 (12) | 60 (13) | 55 (11) | 77 (15) | 66 (13) | 92 (19) | 90 (17) |
| Other/multiple | 13 (2) | 12 (2) | 7 (1) | 13 (3) | 12 (3) | 9 (2) | 12 (2) | 11 (2) | 6 (1) | 6 (1) |
| Education >16 years, n (%) | 279 (47) | 221 (42) | 215 (43) | 228 (44) | 195 (41) | 215 (42) | 202 (39) | 199 (40) | 192 (39) | 191 (37) |
| Current smoker, n (%) | 23 (4) | 17 (3) | 17 (3) | 17 (3) | 22 (5) | 23 (4) | 21 (4) | 25 (5) | 34 (7) | 28 (5) |
| No regular alcohol consumption, n (%) | 382 (65) | 354 (68) | 336 (68) | 338 (66) | 320 (67) | 318 (62) | 370 (72) | 360 (72) | 343 (70) | 374 (72) |
| Exercise test fitness, Mets, median (IQR) | 7.4 (6.1, 9.0) | 7.1 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.4) | 7.0 (5.7, 8.5) | 6.8 (5.6, 8.0) | 6.7 (5.6, 8.0) | 6.6 (5.6, 8) | 6.7 (5.7, 8.0) |
| Physical activity,b kcal/week, median (IQR) | 420 (84, 1254) | 560 (140, 1300) | 502 (92, 176) | 448 (112, 1236) | 616 (196, 1344) | 560 (168, 1344) | 462 (112, 1064) | 574 (140, 1216) | 504 (112, 1236) | 364 (84, 908) |
| Duration of diabetes, years, median (IQR) | 2 (1, 6) | 3 (1, 6) | 4 (1, 8) | 4 (2, 8) | 5 (2, 10) | 5 (3, 9) | 6 (3, 11) | 6 (3, 11) | 7 (4, 12) | 7 (4, 12) |
| Family history of diabetes, n (%) | 340 (58) | 353 (67) | 323 (65) | 325 (63) | 303 (64) | 338 (66) | 336 (65) | 325 (65) | 321 (66) | 383 (74) |
| Diabetes medication—any use, n (%) | 444 (75) | 406 (77) | 426 (86) | 440 (85) | 419 (88) | 458 (89) | 480 (93) | 456 (91) | 473 (97) | 502 (97) |
| Metformin use, n (%) | 307 (52) | 259 (49) | 303 (61) | 310 (60) | 304 (64) | 307 (59) | 345 (67) | 329 (66) | 313 (64) | 343 (66) |
| Sulfonylurea use, n (%) | 192 (32) | 162 (31) | 198 (40) | 203 (39) | 226 (47) | 262 (51) | 277 (54) | 253 (51) | 272 (56) | 287 (55) |
| Thiazolidinedione use, n (%) | 123 (21) | 134 (26) | 117 (24) | 131 (25) | 125 (26) | 134 (26) | 132 (26) | 144 (29) | 145 (30) | 142 (27) |
| Insulin use, n (%) | 23 (4) | 28 (5) | 47 (9) | 46 (9) | 67 (14) | 81 (16) | 100 (19) | 94 (19) | 148 (30) | 161 (31) |
| Number of diabetes medications, mean (SD) | 1.1 (0.9) | 1.1 (0.9) | 1.4 (0.9) | 1.3 (0.9) | 1.6 (1.0) | 1.5 (1.0) | 1.7 (0.9) | 1.7 (1.0) | 1.9 (0.9) | 1.9 (1.0) |
| Body mass index, kg/m2 (SD) | 35 (6) | 36 (5) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 37 (6) | 37 (6) |
| SBP, mm Hg (SD) | 126 (17) | 127 (17) | 128 (17) | 130 (17) | 128 (17) | 130 (18) | 130 (18) | 129 (17) | 130 (18) | 131 (17) |
| DBP, mm Hg (SD) | 70 (9) | 69 (9) | 70 (10) | 70 (10) | 70 (9) | 71 (10) | 70 (10) | 70 (10) | 71 (10) | 72 (10) |
| Hypertension medication use, n (%) | 430 (73) | 385 (73) | 383 (77) | 367 (71) | 367 (77) | 378 (73) | 386 (75) | 377 (75) | 348 (71) | 370 (71) |
| LDL cholesterol, mg/dL (SD) | 112 (31) | 112 (29) | 110 (31) | 111 (31) | 112 (31) | 111 (31) | 112 (30) | 111 (31) | 117 (33) | 117 (33) |
| HDL cholesterol, mg/dL (SD) | 44 (12) | 45 (12) | 44 (12) | 44 (12) | 44 (12) | 43 (11) | 43 (12) | 43 (12) | 42 (11) | 42 (12) |
| Cholesterol medication use, n (%) | 285 (48) | 259 (49) | 264 (53) | 278 (54) | 258 (54) | 273 (53) | 261 (51) | 277 (55) | 238 (49) | 233 (45) |
| Prior history of CVD, n (%) | 66 (11) | 59 (11) | 75 (15) | 59 (11) | 63 (13) | 74 (14) | 87 (17) | 81 (16) | 74 (15) | 74 (14) |
| Characteristicsa . | Quintile 1 . | Quintile 2 . | Quintile 3 . | Quintile 4 . | Quintile 5 . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c %, range | 4.4-6.3 | 6.4-6.8 | 6.9-7.3 | 7.3-8.1 | 8.2-14.5 | |||||
| Intervention arm | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE | ILI | DSE |
| n (% total of quintile) | 591 (53) | 524 (47) | 497 (49) | 515 (51) | 476 (48) | 516 (52) | 516 (51) | 500 (49) | 490 (49) | 520 (51) |
| HbA1c %, mean (SD) | 6.0 (0.3) | 5.9 (0.3) | 6.6 (0.1) | 6.6 (0.1) | 7.1 (0.1) | 7.1 (0.1) | 7.7 (0.2) | 7.7 (0.2) | 9.1 (0.8) | 9.2 (0.9) |
| Female, n (%) | 332 (56) | 316 (60) | 298 (60) | 312 (61) | 284 (60) | 311 (60) | 310 (60) | 293 (59) | 302 (62) | 305 (59) |
| Age, years (SD) | 59 (7) | 59 (7) | 59 (7) | 60 (7) | 59 (7) | 59 (7) | 58 (7) | 59 (7) | 57 (7) | 57 (7) |
| Race/ethnicity, n (%) | ||||||||||
| White | 397 (67) | 351 (67) | 343 (69) | 350 (68) | 301 (63) | 341 (66) | 318 (62) | 312 (62) | 262 (53) | 277 (53) |
| Black | 78 (13) | 67 (13) | 76 (15) | 67 (13) | 74 (16) | 74 (14) | 82 (16) | 89 (18) | 90 (18) | 107 (21) |
| Native American/American Indian/Alaska Native | 31 (5) | 23 (4) | 19 (4) | 17 (3) | 24 (5) | 33 (6) | 21 (4) | 21 (4) | 35 (7) | 34 (7) |
| Asian/Pacific Islander | 10 (2) | 3 (1) | 3 (1) | 7 (1) | 5 (1) | 4 (1) | 6 (1) | 1 (0) | 5 (1) | 6 (1) |
| Hispanic | 62 (10) | 68 (13) | 49 (10) | 61 (12) | 60 (13) | 55 (11) | 77 (15) | 66 (13) | 92 (19) | 90 (17) |
| Other/multiple | 13 (2) | 12 (2) | 7 (1) | 13 (3) | 12 (3) | 9 (2) | 12 (2) | 11 (2) | 6 (1) | 6 (1) |
| Education >16 years, n (%) | 279 (47) | 221 (42) | 215 (43) | 228 (44) | 195 (41) | 215 (42) | 202 (39) | 199 (40) | 192 (39) | 191 (37) |
| Current smoker, n (%) | 23 (4) | 17 (3) | 17 (3) | 17 (3) | 22 (5) | 23 (4) | 21 (4) | 25 (5) | 34 (7) | 28 (5) |
| No regular alcohol consumption, n (%) | 382 (65) | 354 (68) | 336 (68) | 338 (66) | 320 (67) | 318 (62) | 370 (72) | 360 (72) | 343 (70) | 374 (72) |
| Exercise test fitness, Mets, median (IQR) | 7.4 (6.1, 9.0) | 7.1 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.5) | 7.0 (5.8, 8.4) | 7.0 (5.7, 8.5) | 6.8 (5.6, 8.0) | 6.7 (5.6, 8.0) | 6.6 (5.6, 8) | 6.7 (5.7, 8.0) |
| Physical activity,b kcal/week, median (IQR) | 420 (84, 1254) | 560 (140, 1300) | 502 (92, 176) | 448 (112, 1236) | 616 (196, 1344) | 560 (168, 1344) | 462 (112, 1064) | 574 (140, 1216) | 504 (112, 1236) | 364 (84, 908) |
| Duration of diabetes, years, median (IQR) | 2 (1, 6) | 3 (1, 6) | 4 (1, 8) | 4 (2, 8) | 5 (2, 10) | 5 (3, 9) | 6 (3, 11) | 6 (3, 11) | 7 (4, 12) | 7 (4, 12) |
| Family history of diabetes, n (%) | 340 (58) | 353 (67) | 323 (65) | 325 (63) | 303 (64) | 338 (66) | 336 (65) | 325 (65) | 321 (66) | 383 (74) |
| Diabetes medication—any use, n (%) | 444 (75) | 406 (77) | 426 (86) | 440 (85) | 419 (88) | 458 (89) | 480 (93) | 456 (91) | 473 (97) | 502 (97) |
| Metformin use, n (%) | 307 (52) | 259 (49) | 303 (61) | 310 (60) | 304 (64) | 307 (59) | 345 (67) | 329 (66) | 313 (64) | 343 (66) |
| Sulfonylurea use, n (%) | 192 (32) | 162 (31) | 198 (40) | 203 (39) | 226 (47) | 262 (51) | 277 (54) | 253 (51) | 272 (56) | 287 (55) |
| Thiazolidinedione use, n (%) | 123 (21) | 134 (26) | 117 (24) | 131 (25) | 125 (26) | 134 (26) | 132 (26) | 144 (29) | 145 (30) | 142 (27) |
| Insulin use, n (%) | 23 (4) | 28 (5) | 47 (9) | 46 (9) | 67 (14) | 81 (16) | 100 (19) | 94 (19) | 148 (30) | 161 (31) |
| Number of diabetes medications, mean (SD) | 1.1 (0.9) | 1.1 (0.9) | 1.4 (0.9) | 1.3 (0.9) | 1.6 (1.0) | 1.5 (1.0) | 1.7 (0.9) | 1.7 (1.0) | 1.9 (0.9) | 1.9 (1.0) |
| Body mass index, kg/m2 (SD) | 35 (6) | 36 (5) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 36 (6) | 37 (6) | 37 (6) |
| SBP, mm Hg (SD) | 126 (17) | 127 (17) | 128 (17) | 130 (17) | 128 (17) | 130 (18) | 130 (18) | 129 (17) | 130 (18) | 131 (17) |
| DBP, mm Hg (SD) | 70 (9) | 69 (9) | 70 (10) | 70 (10) | 70 (9) | 71 (10) | 70 (10) | 70 (10) | 71 (10) | 72 (10) |
| Hypertension medication use, n (%) | 430 (73) | 385 (73) | 383 (77) | 367 (71) | 367 (77) | 378 (73) | 386 (75) | 377 (75) | 348 (71) | 370 (71) |
| LDL cholesterol, mg/dL (SD) | 112 (31) | 112 (29) | 110 (31) | 111 (31) | 112 (31) | 111 (31) | 112 (30) | 111 (31) | 117 (33) | 117 (33) |
| HDL cholesterol, mg/dL (SD) | 44 (12) | 45 (12) | 44 (12) | 44 (12) | 44 (12) | 43 (11) | 43 (12) | 43 (12) | 42 (11) | 42 (12) |
| Cholesterol medication use, n (%) | 285 (48) | 259 (49) | 264 (53) | 278 (54) | 258 (54) | 273 (53) | 261 (51) | 277 (55) | 238 (49) | 233 (45) |
| Prior history of CVD, n (%) | 66 (11) | 59 (11) | 75 (15) | 59 (11) | 63 (13) | 74 (14) | 87 (17) | 81 (16) | 74 (15) | 74 (14) |
Abbreviations: BMI, body mass index; CVD, cardiovascular disease; DBP, diastolic blood pressure; DSE, diabetes support and education; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; ILI, intensive lifestyle intervention; IQR, interquartile range; kcal, kilo-calories; LDL, low-density lipoprotein; Mets, metabolic equivalents; mm Hg, millimeters mercury; SBP, systolic blood pressure.
aValues are means (SD) or counts (column percentage) except when noted for “range” and “median (IQR).”
bPaffenbarger physical activity questionnaire data was missing for 53% of the sample, similar missing data percentage by randomization arm within HbA1c quintile.
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