Table 1.
Pre-Treatment | Post-Treatment | P-value | Change | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Mean | SD | N | Mean | SD | N | Mean | SD | N | ||
Height, cm | 148 | 8.2 | 37 | 151 | 8.3 | 37 | <0.0001 | 3.38 | 0.96 | 37 |
Weight, kg | 65.2 | 18.4 | 37 | 64.3 | 20.1 | 37 | 0.29 | −0.89 | 5.14 | 37 |
BMI, kg/m2 | 29.5 | 7.0 | 37 | 28.1 | 7.6 | 37 | <0.0001 | −1.47 | 2.18 | 37 |
BMI z-score | 2.24 | 0.31 | 37 | 2.01 | 0.44 | 37 | <0.0001 | −0.23 | 0.23 | 37 |
BMI % over the 95th | 28.5 | 28.7 | 37 | 19.5 | 30.9 | 37 | <0.0001 | −9.01 | 9.26 | 37 |
Fat mass, kg | 31.6 | 14.2 | 37 | 30.6 | 16.2 | 35 | 0.06 | −1.29 | 4.07 | 35 |
Fat mass, % | 48.1 | 6.8 | 37 | 45.3 | 8.5 | 35 | <0.0001 | −2.81 | 3.50 | 35 |
Lean mass, kg | 32.4 | 5.2 | 37 | 34.0 | 5.6 | 35 | <0.0001 | 1.55 | 1.69 | 35 |
Lean mass, % | 51.9 | 6.8 | 37 | 54.7 | 8.5 | 35 | <0.0001 | 2.81 | 3.50 | 35 |
Waist circumference, cm | 96.1 | 14.1 | 37 | 95.8 | 16.5 | 37 | 0.77 | −0.28 | 5.75 | 37 |
Activity, avg min/d | 35.8 | 21.4 | 37 | 38.1 | 23.8 | 35 | 0.55 | 2.37 | 23.8 | 35 |
Healthy Eating Index | 54.1 | 12.0 | 37 | 60.8 | 12.4 | 34 | 0.008 | 6.07 | 14.4 | 34 |
Leptin, ng/mL | 34.1 | 22.0 | 35 | 27.3 | 19.6 | 35 | 0.007 | −7.43 | 15.5 | 33 |
HOMA-IR | 3.95 | 3.75 | 33 | 4.56 | 3.62 | 34 | 0.28 | 0.69 | 3.41 | 30 |
Data reported as mean (SD). Pre-treatment vs. Post-treatment comparisons are unadjusted and were done by linear mixed model. Height, weight and BMI parameters measured at Week 1 and Week 24 of FBT. All other measures were assessed at pre-treatment and post-treatment study visits. BMI parameters were calculated with LMS values by sex and age and BMI % over the 95th was calculated as the percent the current BMI was over the estimated 95% BMI percentile (https://www.cdc.gov/growthcharts/percentile_data_files.htm). Body composition parameters were by bioelectrical impedance analysis. Activity is moderate and vigorous levels (average min/d from 7 days of consecutive wear). Healthy Eating Index calculated based on 2010 criteria.