Table 2. Primary Outcome and Anthropometric Features by Treatment Arm.
| Outcome or feature | Baseline | At surgery | At 2 wk after surgery | At 12 mo | At 24 mo | Difference from baseline to 12 mo | Difference from baseline to 24 mo | Difference between arms at 12 mo | Difference between arms at 24 mo | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Participants, No. | Mean (SD) | Participants, No. | Mean (SD) | Participants, No. | Mean (SD) | Participants, No. | Mean (SD) | Participants, No. | Hierarchical regression | P value | Hierarchical regression | P value | Hierarchical regression | P value | Hierarchical regression | P value | |||||
| Mean (SE) | 95% CI | Mean (SE) | 95% CI | Mean (SE) | 95% CI | Mean (SE) | 95% CI | |||||||||||||||
| ICP (intention to treat), cm CSF | ||||||||||||||||||||||
| CWM intervention | 34.6 (5.6) | 33 | NA | NA | NA | NA | 32.0 (5.2) | 25 | 31.0 (5.7) | 18 | −2.5 (1.4) | −5.2 to 0.3 | .08 | −3.5 (1.6) | −6.6 to −0.3 | .03 | −6.0 (1.8) | −9.5 to −2.4 | .001 | −8.2 (2.0) | −12.2 to −4.2 | <.001 |
| Bariatric surgery | 34.8 (5.8) | 33 | NA | NAa | 26.9 (8.1) | 18 | 26.4 (8.7) | 29 | 22.8 (7.8) | 22 | −8.7 (1.3) | −11.3 to −6.1 | <.001 | −11.9 (1.5) | −14.8 to −9.0 | <.001 | ||||||
| ICP (per protocol), cm CSF | ||||||||||||||||||||||
| CWM intervention | 34.6 (5.9) | 33 | NA | NA | NA | NA | 32.4 (6.5) | 26 | 31.4 (5.9) | 17 | −1.9 (1.4) | −4.6 to 0.7 | .15 | −3.0 (1.6) | −6.1 to 0.1 | .06 | −7.2 (1.8) | −10.6 to −3.7 | <.001 | −8.7 (2.0) | −12.7 to −4.8 | <.001 |
| Bariatric surgery | 34.9 (5.4) | 30 | NA | NAa | NA | NA | 25.7 (7.5) | 28 | 22.8 (7.4) | 23 | −9.4 (1.3) | −12.1 to −6.8 | <.001 | −12.1 (1.4) | −14.9 to −9.3 | <.001 | ||||||
| Weight, kg | ||||||||||||||||||||||
| CWM intervention | 118.5 (20.7) | 33 | NA | NA | NA | NA | 116.6 (22.3) | 29 | 116.5 (22.9) | 22 | −2.1 (2.0) | −6.0 to 1.8 | .29 | −1.4 (2.2) | −5.6 to 2.9 | .53 | −21.4 (5.4) | −32.1 to −10.7 | <.001 | −26.6 (5.6) | −37.5 to −15.7 | <.001 |
| Bariatric surgery | 118.4 (21.8) | 33 | 113.3 (21.7) | 27 | 102.3 (18.8) | 18 | 94.0 (23.7) | 30 | 88.9 (25.9) | 24 | −23.4 (1.9) | −27.2 to −19.6 | <.001 | −27.8 (2.1) | −31.9 to −23.8 | <.001 | ||||||
| Excess body weight, kg | ||||||||||||||||||||||
| CWM intervention | 50.6 (19.4) | 33 | NA | NA | NA | NA | 49.1 (21.3) | 29 | 49.5 (22.1) | 22 | −1.9 (1.9) | −5.7 to 1.9 | .32 | −1.3 (2.1) | −5.5 to 2.8 | .53 | −20.3 (5.1) | −30.3 to −10.2 | <.001 | −25.8 (5.3) | −36.1 to −15.5 | <.001 |
| Bariatric surgery | 51.5 (20.0) | 33 | 46.2 (20.0) | 27 | 36.5 (16.4) | 18 | 27.2 (22.3) | 30 | 21.2 (24.9) | 24 | −23.0 (1.9) | −26.8 to −19.3 | <.001 | −28.0 (2.1) | −32.0 to −23.9 | <.001 | ||||||
| BMI | ||||||||||||||||||||||
| CWM intervention | 43.7 (7.1) | 33 | NA | NA | NA | NA | 43.1 (7.8) | 29 | 43.5 (8.0) | 22 | −0.7 (0.7) | −2.1 to 0.7 | .35 | −0.4 (0.8) | −1.9 to 1.2 | .62 | −7.3 (1.9) | −11.0 to −3.7 | <.001 | −9.4 (1.9) | −13.2 to −5.7 | <.001 |
| Bariatric surgery | 44.2 (7.1) | 33 | 42.2 (7.1) | 27 | 38.9 (5.7) | 18 | 35.1 (8.0) | 30 | 32.8 (8.9) | 24 | −8.5 (0.7) | −9.9 to −7.2 | <.001 | −10.4 (0.8) | −11.8 to −8.9 | <.001 | ||||||
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CSF, cerebrospinal fluid; CWM, community weight management; ICP, intracranial pressure; NA, not applicable.
a
Intracranial pressure was not assessed until 2 weeks after surgery was performed.