Table 1. Baseline characteristics of the study groupsa.
|
AspireAssist |
Lifestyle Counseling |
|||
|---|---|---|---|---|
| Modified intention-to-treat analysis | Completer analysis | Modified intention-to-treat analysis | Completer analysis | |
| N | 111 | 82 | 60 | 31 |
| Sex—n (%) | ||||
| Male | 15 (13.5) | 14 (17.1) | 7 (11.7) | 4 (12.9) |
| Female | 96 (86.5) | 68 (82.9) | 53 (88.3) | 27 (87.1) |
| Age—years | 42.4±10.0 | 43.5±10.2 | 46.8±11.6 | 47.6±11.4 |
| Race or ethnic group—n (%)b | ||||
| White, non-Hispanic | 63 (56.8) | 51 (62.2) | 31 (51.7) | 16 (51.6) |
| Black or African American | 33 (29.7) | 21 (25.6) | 17 (28.3) | 10 (32.3) |
| Hispanic or Latino | 11 (9.9) | 8 (9.8) | 11 (18.3) | 4 (12.9) |
| Other | 4 (3.6) | 2 (2.4) | 1 (1.7) | 1 (3.2) |
| Weight—kg | 116.9±21.2 | 119.1±21.0 | 112.8±16.1 | 114.7±14.8 |
| Body mass index—kg/m2 c | 42.0±5.1 | 42.4±5.0 | 40.9±3.9 | 41.3±4.0 |
| Blood pressure—mm Hg | ||||
| Systolic | 124.4±13.6 | 124.2±13.3 | 127.3±15.0 | 124.5±13.4 |
| Diastolic | 78.9±8.9 | 78.8±8.1 | 78.1±8.8 | 73.1±6.8 |
| Cholesterol—mg/dl | ||||
| Total | 194.3±38.2 | 193.8±37.4 | 198.8±36.0 | 199.3±28.4 |
| LDL | 115.8±33.1 | 115.4±32.8 | 119.0±31.0 | 119.2±31.8 |
| HDL | 52.7±13.3 | 52.2±14.4 | 51.8±12.3 | 53.8±12.6 |
| Triglycerides—mg/dl | 136.1±77.9 | 140.8±81.7 | 125.3±77.3 | 133.8±53.7 |
| Fasting glucose—mg/dl | 92.9±20.2 | 93.5±23.1 | 94.3±20.3 | 93.7±11.5 |
| Glycated hemoglobin—% | 5.7±0.6 | 5.7±0.5 | 5.8±0.6 | 5.7±0.5 |
| Diabetes—n (%)d | 3 (2.7) | 2 (2.4) | 8 (13.3) | 3 (9.7) |
| Dyslipidemia—n (%)d | 86 (77.5) | 68 (82.9) | 51 (85.0) | 27 (87.1) |
| Hypertension—n (%)d | 46 (41.4) | 37 (45.1) | 24 (40.0) | 8 (25.8) |
a
Plus–minus values are observed means±s.d. There were no statistically significant differences between the two groups for any characteristic for either the mITT or the completer populations. To convert values for glucose to millimoles per liter, multiply by 0.05551. To convert values for cholesterol to millimoles per liter, multiply by 0.0259. HDL, high-density lipoprotein; LDL, low-density lipoprotein.
b
Race and ethnic group were self-reported.
c
The body mass index is the weight in kilograms divided by the square of the height in meters.
d
The diagnoses of diabetes, dyslipidemia, and hypertension were based on self-reported medical history and medical evaluation at screening.