Table 5.
Change in outcomes from baseline to 6 months by weight change category at 6 months.
| Weight Change Category | |||||
|---|---|---|---|---|---|
| Participants with Weight Gain or No Weight Loss | Participants with <5% Weight Loss | Participants with 5% to <10% Weight Loss | Participants with ≥10% Weight Loss | P-value* | |
| Body Weight change, kg | |||||
| N | 30 | 94 | 121 | 179 | |
| Median change (25th, 75th %-iles) | 1.2 (0.4, 2.5) | −2.4 (−3.5, −1.2) | −6.4 (−8.0, −5.5) | −13.2 (−17.8, −10.5) | NA*** |
| Fat mass, kg | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 5 (17.2%) | 80 (85.1%) | 120 (100%) | 179 (100%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −0.9 (−1.2, −0.4) | −2.2 −3.1, −1.4) | −5.5 (−6.7, −4.2) | −10.7 (−13.8, −8.4) | <0.0001 |
| Lean mass, kg | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 10 (34.5%) | 55 (58.5%) | 95 (79.2%) | 166 (94.7%) | <0.0001 |
| Median loss (25th, 75th %-iles)** | −0.8 (−0.3, −0.1) | −0.8 (−1.2, −0.5) | −1.3 (−1.9, −0.6) | −2.4 (−3.6, −1.5) | <0.0001 |
| Percent body fat, % | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 8 (27.6%) | 77 (81.9%) | 119 (99.2%) | 179 (100%) | <0.0001 |
| median reduction (25th, 75th %-iles)** | -0.6 (−1.0, −0.3) | −1.5 (−2.0, −0.9) | −3.2 (−4.6, −2.3) | −6.9 (−9.5, −5.2) | <0.0001 |
| **** Tissue percent body fat, % | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 9 (31.0%) | 76 (80.9%) | 119 (99.2%) | 179 (100%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −0.6 (−0.9, −0.2) | −1.5 (−2.1, −0.9) | −3.2 (−4.7, −2.3) | −6.9 (−9.7, −5.2) | <0.0001 |
| Percent lean mass, % | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 21 (72.4%) | 17 (18.1%) | 1 (0.8%) | 0 (0%) | <0.0001 |
| Median loss (25th, 75th %-iles)** | −1.0 (−1.6, −0.5) | −0.6 (−1.2, −0.4) | −0.4 (NA) | NA | 0.21 |
| **** Tissue percent lean mass, % | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 20 (69.0%) | 18 (19.2%) | 1 (0.8%) | 0 (10%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −1.0 (−1.6, −0.5) | −0.6 (−1.3, −0.5) | −0.5 (NA) | NA | 0.12 |
| Bone Mass, kg | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 11 (37.9%) | 47 (50.0%) | 76 (63.3%) | 140 (78.2%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −0.018 (−0.035, −0.008) | −0.018 (−0.30, −0.009) | −0.024 (−0.042, −0.011) | −0.032 (−0.054, −0.017) | <0.0001 |
| Total Body Bone Mineral Density, g/cm2 | 29 | 94 | 120 | 179 | |
| N with reduction (% with reduction) | 15 (51.7%) | 48 (51.1%) | 62 (51.7%) | 70 (39.1%) | 0.04 |
| Median reduction (25th, 75th %-iles)** | 0.010 (0.005, 0.020) | 0.009 (0.005, 0.017) | 0.006 (0.003, 0.016) | 0.015 (0.008, 0.020) | 0.17 |
| Resting Heart Rate (beat per minute) | 29 | 93 | 121 | 179 | |
| N with reduction (% with reduction) | 11 (37.9%) | 65 (69.9%) | 90 (74.4%) | 149 (83.2%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −7.5 (−13.5, −3.5) | −6.5 (−11.0, −4.0) | −7.5 (−12.0, −4.0) | −9.0 (−14.5, −4.0) | 0.01 |
| Systolic Blood Pressure (mmHg) | 29 | 93 | 121 | 179 | |
| N with reduction (% with reduction) | 17 (58.6%) | 60 (64.5%) | 79 (65.3%) | 136 (76.0%) | 0.01 |
| Median reduction (25th, 75th %-iles)** | −5.0 (−9.5, −1.5) | −5.5 (−8.3, −3.0) | −6.0 (−9.0, −2.5) | −8.0 (−12.0, −4.5) | 0.0001 |
| Diastolic Blood Pressure (mmHg) | 29 | 93 | 121 | 179 | |
| N with reduction (% with reduction) | 17 (56.7%) | 62 (66.0%) | 83 (68.6%) | 130 (72.6%) | 0.05 |
| Median reduction (25th, 75th %-iles)** | −5.5 (−8.3, −2.3) | −4.0 (−7.0, −2.0) | −5.5 (−8.2, −3.0) | −6.1 (−9.5, −3.0) | 0.01 |
| Total Cholesterol (mg/dl) | 28 | 91 | 120 | 177 | |
| N with reduction (% with reduction) | 15 (53.6%) | 52 (57.1%) | 85 (70.8%) | 151 (85.3%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −21.0 (−32.0, −6.0) | −14.5 (−23.5, −8.0) | −16.0 (−29.0, −8.0) | −28.0 (−40.0, −15.0) | <0.0001 |
| LDL Cholesterol (mg/dl) | 28 | 91 | 120 | 177 | |
| N with reduction (% with reduction) | 15 (53.6%) | 48 (52.8%) | 84 (70.0%) | 142 (29.1%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −12.0 (−24.8, −8.0) | −14.9 (−21.4, −7.9) | −11.4 (−22.0, −5.9) | −20.2 (−32.2, −12.0) | <0.0001 |
| HDL Cholesterol (mg/dl) | 28 | 91 | 120 | 177 | |
| N with increase (% with reduction) | 13 (46.4%) | 42 (46.2%) | 62 (51.7%) | 90 (50.9%) | 0.47 |
| Median increase (25th, 75th %-iles)** | 5.4 (4.3, 7.4) | 7.0 (3.6, 10.4) | 4.7 (2.5, 8.0) | 6.7 (2.6, 11.1) | 0.84 |
| Triglycerides (mg/dl) | 28 | 91 | 120 | 177 | |
| N with reduction (% with reduction) | 15 (53.6%) | 46 (50.6%) | 74 (61.7%) | 127 (71.8%) | <0.001 |
| Median reduction (25th, 75th %-iles)** | −16.0 (−29.0, −5.0) | −18.0 (−34.0, −11.0) | −17.5 (−47.0, −7.0) | −48.0 (−80.0, −21.0) | <0.0001 |
| Glucose (mg/dl) | 28 | 91 | 120 | 177 | |
| N with reduction (% with reduction) | 15 (53.6%) | 52 (57.1%) | 80 (66.7%) | 132 (74.6%) | 0.001 |
| Median reduction (25th, 75th %-iles)** | −5.0 (−9.0, −3.0) | −5.0 (−8.0, −3.0) | −6.0 (−8.5, −4.0) | −8.0 (−11.0, −4.5) | <0.001 |
| Insulin (μU/ml) | 28 | 91 | 120 | 177 | |
| N with reduction (% with reduction) | 15 (53.6%) | 52 (57.1%) | 84 (70.0%) | 146 (82.5%) | <0.0001 |
| Median reduction (25th, 75th %-iles)** | −2.5 (−2.9, −0.8) | −3.1 (−4.7, −1.5) | −3.7 (−6.4, −2.2) | −5.9 (−9.0, −2.8) | <0.0001 |
| Fitness (ml/mg/min) | 30 | 93 | 120 | 173 | |
| N with increase (% with increase) | 14 (46.7%) | 70 (75.3%) | 93 (77.5%) | 163 (94.2%) | <0.0001 |
| Median increase (25th, 75th %-iles)** | 1.7 (0.9, 3.7) | 2.8 (1.1, 4.5) | 4.1 (2.1, 5.6) | 6.2 (3.8, 9.2) | <0.0001 |
*
The Cochran-Armitage trend test was used to test whether there was a trend in the proportion with a change in the outcome by the ordinal weight change variable. The Jonckheere-Terpstra trend test was used to test whether there was a trend in the magnitude of change in the outcome by the ordinal weight change variable only among those with some change.
**
Data represent that change for those designated to have a reduction or increase in the specified variable.
***
Ordinal weight change categories were created by applying clinically meaningful cut points to the continuous weight change measure.
****
Excluding bone mass.