Table 2:
Changes in patient reported outcomes based on weight loss
| Weight loss at 6 months | Weight loss at 12 months | |||
|---|---|---|---|---|
| < 5% | ≥ 5% | < 5% | ≥ 5% | |
| Physical Function | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 49.8 (8.1) | 49.3 (6.6) | 49.6 (8.3) | 49.7 (6.8) |
| Follow-up, mean (SD) | 50.1 (8.2) | 53.7 (8.6) | 49.6 (7.9) | 53.3 (8.3) |
| Δ from BL, mean [95% CI] | 0.3 [−1.8, 2.4] | 4.4 [2.4, 6.4] | 0 [−1.9, 1.8] | 3.6 [0.6, 6.6] |
| P, within group** | >0.99 | 0.009 | 0.72 | 0.04 |
| P, between groups*** | 0.02 | 0.04 | ||
| Sexual Function | ||||
| No. in analysis | 55 | 27 | 43 | 24 |
| BL, mean (SD)* | 40.2 (42.4) | 28.2 (35.3) | 36.4 (40.4) | 27.2 (35.2) |
| Follow-up, mean (SD) | 34.2 (38.9) | 18.5 (27.5) | 36.6 (39.2) | 24.8 (31.2) |
| Δ from BL, mean [95% CI] | −5.9 [−11.2, −0.7] | −9 [−16.7, −1.3] | 0.2 [−7.2, 7.6] | −1.3 [−9.1, 6.4] |
| P, within group** | 0.31 | 0.29 | 0.85 | 0.84 |
| P, between groups*** | 0.76 | 0.95 | ||
| Endocrine Symptoms | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 39.4 (11.2) | 42.4 (8.9) | 40.7 (10.8) | 43.4 (8.7) |
| Follow-up, mean (SD) | 40 (10.3) | 45.4 (9.1) | 41.4 (10.8) | 46.1 (8.5) |
| Δ from BL, mean [95% CI] | 0.7 [−1.8, 3.1] | 2.9 [0.9, 4.9] | 0.7 [−1.8, 3.1] | 2.7 [0.7, 4.7] |
| P, within group** | 0.47 | 0.02 | 0.53 | 0.006 |
| P, between groups*** | 0.43 | 0.3 | ||
| Pain Interference | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 49.3 (8) | 48.8 (8.8) | 48.6 (8.2) | 47.7 (8.6) |
| Follow-up, mean (SD) | 49.9 (7.6) | 48.4 (8.5) | 49.1 (8.8) | 45 (6) |
| Δ from BL, mean [95% CI] | 0.6 [−1.4, 2.7] | −0.4 [−3.3, 2.6] | 0.5 [−1.6, 2.5] | −2.6 [−5.1, −0.2] |
| P, within group** | 0.56 | 0.83 | 0.8 | 0.07 |
| P, between groups*** | 0.61 | 0.19 | ||
| Fatigue | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 51.4 (7.8) | 48.7 (7.7) | 50.4 (8) | 47.7 (7.3) |
| Follow-up, mean (SD) | 51 (8.5) | 45.7 (7.6) | 49.4 (8.7) | 44.2 (6.9) |
| Δ from BL, mean [95% CI] | −0.4 [−2.5, 1.6] | −3 [−4.9, −1] | −1 [−3.3, 1.2] | −3.5 [−6.1, −0.9] |
| P, within group** | 0.91 | 0.09 | 0.54 | 0.02 |
| P, between groups*** | 0.28 | 0.23 | ||
| Depression | ||||
| No. in analysis | 55 | 28 | 41 | 25 |
| BL, mean (SD)* | 45.7 (8.9) | 45.3 (7.2) | 45.6 (9.3) | 45.4 (7.3) |
| Follow-up, mean (SD) | 46.3 (9.5) | 44.6 (8) | 44.6 (8.4) | 43.7 (8.2) |
| Δ from BL, mean [95% CI] | 0.6 [−1.3, 2.5] | −0.6 [−2.4, 1.1] | −1 [−3.3, 1.3] | −1.7 [−4.3, 0.8] |
| P, within group** | 0.75 | 0.42 | 0.33 | 0.21 |
| P, between groups*** | 0.45 | 0.84 | ||
| Anxiety | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 49.2 (8.6) | 48.9 (7.9) | 48.9 (8.8) | 48.7 (8.2) |
| Follow-up, mean (SD) | 49 (8.7) | 46.6 (8.4) | 48.2 (8.3) | 45.3 (8.1) |
| Δ from BL, mean [95% CI] | −0.2 [−2.3, 1.9] | −2.3 [−4.7, 0.1] | −0.7 [−3.4, 2] | −3.3 [−5.8, −0.9] |
| P, within group** | 0.73 | 0.05 | 0.67 | 0.008 |
| P, between groups*** | 0.16 | 0.18 | ||
| Sleep Disturbance | ||||
| No. in analysis | 55 | 28 | 43 | 25 |
| BL, mean (SD)* | 52 (9.2) | 49 (7.9) | 51.8 (9.2) | 48.9 (8.4) |
| Follow-up, mean (SD) | 51.7 (9.6) | 48.1 (8.3) | 51.8 (6.8) | 49.2 (4.7) |
| Δ from BL, mean [95% CI] | −0.3 [−2.4, 1.8] | −0.9 [−3.6, 1.7] | −0.1 [−2.1, 2] | 0.3 [−2.2, 2.7] |
| P, within group** | 0.71 | 0.25 | 0.85 | 0.86 |
| P, between groups*** | 0.27 | 0.99 | ||
*
Values are the mean (SD) of baseline measures among those with data at the follow-up time point
**
P value for differential change in the PRO within weight loss groups at 6 and 12 months, estimated from a linear mixed effects regression model with the PRO as the outcome and terms for weight loss group (1 indicator variable)
***
P value for differential change in the PRO between weight loss groups at 6 and 12 months, estimated from a linear mixed effects regression model with the PRO as the outcome and terms for weight loss group (1 indicator variable), time point (2 indicator variables), and their interaction (2 terms)