Table 2. Weight Loss, Depression, and Anxiety Outcomes.
| Unadjusted Estimates | Treatment Difference | |||
|---|---|---|---|---|
| Intervention | Usual Care | Adjusted Between-Group Difference (95% CI)a | P Value | |
| Primary Outcomes | ||||
| Body mass index | ||||
| No. of participants | 202 | 198 | ||
| At 6 mo, mean (SD) | 36.0 (6.9) | 36.6 (6.2) | Mean, −0.6 (−0.9 to −0.3) | <.001 |
| At 12 mo, mean (SD) | 35.9 (7.1) | 36.6 (6.0) | Mean, −0.7 (−1.1 to −0.2) | .01 |
| 20-Item Depression Symptom Checklist (SCL-20) scoreb | ||||
| No. of participants | 184 | 187 | ||
| At 6 mo, mean (SD) | 1.1 (0.7) | 1.4 (0.8) | Mean, −0.3 (−0.4 to −0.1) | <.001 |
| At 12 mo, mean (SD) | 1.1 (1.0) | 1.4 (1.3) | Mean, −0.2 (−0.4 to 0) | .01 |
| Secondary Outcomes | ||||
| Weight, kg | ||||
| No. of participants | 202 | 198 | ||
| At 6 mo, mean (SD) | 101.5 (21.9) | 103.2 (21.1) | Mean, −1.9 (−2.9 to −1.0) | <.001 |
| At 12 mo, mean (SD) | 100.8 (22.8) | 103.4 (20.9) | Mean, −2.0 (−3.3 to −0.6) | .004 |
| Depression treatment response (≥50% decrease in SCL-20 score from baseline) | ||||
| No. of participants | 184 | 187 | ||
| At 6 mo, No. (%) | 55 (31) | 29 (16) | 21.2 (9.8 to 33.3)c | <.001 |
| At 12 mo, No. (%) | 49 (29) | 38 (22) | 10.3 (−1.3 to 21.6)c | .09 |
| Complete remission of depression symptoms (defined as SCL-20 score <0.50) | ||||
| No. of participants | 184 | 187 | ||
| At 6 mo, No. (%) | 31 (18) | 10 (6) | 14.4 (5.0 to 26.3)c | <.001 |
| At 12 mo, No. (%) | 30 (18) | 23 (13) | 4.7 (−3.8 to 16.0)c | .28 |
| 7-Item Generalized Anxiety Disorder scale total scored | ||||
| No. of participants | 154 | 160 | ||
| At 6 mo, mean (SD) | 5.1 (4.5) | 6.4 (4.5) | Mean, −1.2 (−2.1 to −0.3) | .01 |
| At 12 mo, mean (SD) | 4.2 (3.8) | 6.1 (4.6) | Mean, −1.5 (−2.4 to −0.5) | .003 |
| Post Hoc Outcomes | ||||
| ≥5% Weight loss from baseline | ||||
| No. of participants | 202 | 198 | ||
| At 6 mo, No. (%) | 48 (24) | 17 (9) | 11.4 (4.5 to 22.2)c | <.001 |
| At 12 mo, No. (%) | 51 (28) | 27 (15) | 9.8 (2.9 to 20.4)c | .003 |
For the means, adjustment was made using a linear mixed model. For the proportions, adjustment was made using a generalized linear mixed model. The mean and the proportion data were calculated using model-based estimates. The 95% CIs were obtained using model-based intervals for differences in the means and using bootstrapping for the differences in the proportions. The mixed-effects models accounted for the random effects of the repeated measures and primary care physicians and were adjusted for the baseline value of the outcome of interest, clinic, age, sex, race/ethnicity, education level, use of any antidepressant medications at the time of enrollment, and the number of hospitalizations during the 12 months before randomization.
Data are average scores for the 20 items. Score range: 0 (not depressed at all) to 4 (extremely depressed).
Expressed as proportions.
Data are total scores for the 7 items. Score range: 0 (no symptoms) to 21 (most severe symptoms).