Table 1.
Baseline Characteristics by Intervention Arm
Variable | Combined Active N=297 | Combined Placebo N=247 | p-value1 | ||
---|---|---|---|---|---|
| |||||
n | % | N | % | ||
Age, mean (SD) | 54.4 (4.1) | 54.3 (3.8) | 0.88 | ||
| |||||
Ethnicity | 0.86 | ||||
White | 166 | 55.9 | 139 | 56.3 | |
African American | 117 | 39.4 | 94 | 38.1 | |
Other / Unknown | 14 | 4.7 | 14 | 5.7 | |
| |||||
Menopause Status | 0.86 | ||||
Menopause transition | 53 | 17.8 | 40 | 16.2 | |
Postmenopause | 216 | 72.7 | 182 | 73.7 | |
Indeterminate2 | 28 | 9.4 | 25 | 10.1 | |
| |||||
Years of hot flashes, mean (SD) | 6.5 (6.0) | 6.3 (5.5) | 0.66 | ||
| |||||
PHQ-9 Depression >=5 | 83 | 27.9 | 61 | 24.7 | 0.39 |
| |||||
SCL Anxiety > 0.3 | 70 | 23.6 | 66 | 26.7 | 0.65 |
| |||||
BMI, mean (SD) | 28.8 (6.6) | 28.4 (6.7) | 0.58 | ||
≥ 30 kg/m2 (n, %) | 102 | 34.3 | 83 | 33.6 | 0.95 |
| |||||
≤ High school / GED | 46 | 15.5 | 47 | 19.0 | 0.30 |
| |||||
Full-time employment | 140 | 47.1 | 115 | 46.6 | 0.55 |
| |||||
≥ 1 alcoholic drink / day | 46 | 15.5 | 44 | 17.8 | 0.28 |
| |||||
Current smoker | 52 | 17.5 | 50 | 20.2 | 0.71 |
| |||||
Screening HF Variables | |||||
| |||||
Average HF / Day, mean (SD) | 8.9 (5.9) | 8.5 (5.0) | 0.38 | ||
| |||||
HF Frequency SD, mean (SD) | 2.0 (1.3) | 1.9 (1.1) | 0.50 | ||
| |||||
Average HF severity, mean (SD) | 2.1 (0.5) | 2.1 (0.5) | 0.89 | ||
| |||||
Average HF bother, mean (SD) | 3.1 (0.5) | 3.1 (0.5) | 0.96 |
p-values from t-tests for continuous and chi-square tests for categorical characteristics
Menses indeterminate, met hormone or other criteria