Table 2.
Change in weight, body mass index, body composition, and cardiorespiratory fitness by intervention condition.
| Least-Squares Mean (95% CI)* | ||||||||
|---|---|---|---|---|---|---|---|---|
| Change from baseline | P value** | |||||||
| Baseline | 6 months | 12 months | 18 months | 24 months | Group | Time | Group × Time | |
| Weight, kg**** | 0.07 | <0.0001 | 0.003 | |||||
| SBWI group | 95.2 (93, 97.3) | −8.6 (−9.5, −7.7) | −8.3 (−9.2, −7.4) | −7.3 (−8.3, −6.4) | −5.9 (−6.8, −5) | |||
| EBWI group | 96.3 (94.2, 98.5) | −8 (−8.8, −7.1) | −6.7 (−7.6, −5.8) | −5.4 (−6.3, −4.4) | −3.5 (−4.5, −2.6) | |||
| Difference | −0.7 (−1.9, 0.6) | −1.6 (−2.8, −0.3) | −2 (−3.3, −0.6) | −2.4 (−3.7, −1) | ||||
| P value*** | 0.29 | 0.032 | 0.011 | 0.002 | ||||
| Weight change from baseline, %***** | – | 0.014 | <0.0001 | <0.001 | ||||
| SBWI group | – | −9.4 (−10.2, −8.5) | −8.9 (−9.8, −8) | −7.9 (−8.9, −7) | −6.4 (−7.4, −5.5) | |||
| EBWI group | – | −8.4 (−9.3, −7.6) | −7 (−7.9, −6.1) | −5.6 (−6.5, −4.6) | −3.6 (−4.5, −2.7) | |||
| Difference | – | −0.9 (−2.2, 0.3) | −1.9 (−3.2, −0.6) | −2.4 (−3.7, −1) | −2.8 (−4.2, −1.5) | |||
| P value*** | – | 0.15 | 0.008 | 0.002 | <0.001 | |||
| Body mass index, kg/m2 | 0.41 | <.0001 | 0.63 | |||||
| SBWI group | 32.4 (31.5 to 33.3) | −2.9 (−3.7 to −2.2) | −2.8 (−3.5 to −2.0) | −2.5 (−3.3 to −1.7) | −1.8 (−2.6 to −1.0) | |||
| EBWI group | 32.3 (31.4 to 33.2) | −2.7 (−3.4 to −1.9) | −2.1 (−2.9 to −1.4) | −1.9 (−2.7 to −1.1) | −1.1 (−1.9 to −0.3) | |||
| Difference | −0.3 (−1.3 to 0.8) | −0.7 (−1.7 to 0.4) | −0.6 (−1.8 to 0.5) | −0.7 (−1.9 to 0.4) | ||||
| Fat mass, kg | >0.99 | <0.0001 | 0.52 | |||||
| SBWI group | 36.8 (35.4, 38.3) | −7 (−7.8, −6.3) | −7 (−7.7, −6.2) | −6 (−6.8, −5.2) | −5.1 (−6, −4.3) | |||
| EBWI group | 37.2 (35.7, 38.7) | −6.5 (−7.2, −5.8) | −5.7 (−6.5, −4.9) | −4.8 (−5.6, −4) | −3.4 (−4.3, −2.6) | |||
| Difference | −0.6 (−1.6, 0.5) | −1.3 (−2.4, −0.2) | −1.2 (−2.3, −0.1) | −1.7 (−2.9, −0.6) | ||||
| Lean mass, kg | >0.99 | <0.0001 | >0.99 | |||||
| SBWI group | 54.9 (53.9, 55.8) | −1.3 (−1.5, −1.1) | −1.3 (−1.5, −1.1) | −1.1 (−1.3, −0.8) | −0.9 (−1.1, −0.6) | |||
| EBWI group | 55.6 (54.7, 56.6) | −1.2 (−1.5, −1) | −1.1 (−1.4, −0.9) | −0.7 (−0.9, −0.4) | −0.6 (−0.8, −0.3) | |||
| Difference | 0 (−0.4, 0.3) | −0.1 (−0.5, 0.2) | −0.4 (−0.7, 0) | −0.3 (−0.7, 0) | ||||
| Percent body fat, % | >0.99 | <0.0001 | 0.52 | |||||
| SBWI group | 38.9 (38, 39.8) | −4.7 (−5.2, −4.2) | −4.6 (−5.2, −4.1) | −4 (−4.5, −3.5) | −3.5 (−4, −3) | |||
| EBWI group | 38.8 (37.8, 39.7) | −4.1 (−4.6, −3.6) | −3.7 (−4.2, −3.2) | −3.2 (−3.7, −2.7) | −2.4 (−3, −1.9) | |||
| Difference | −0.6 (−1.3, 0.1) | −1 (−1.7, −0.3) | −0.8 (−1.6, −0.1) | −1.1 (−1.9, −0.3) | ||||
| Tissue****** percent body fat, % | >0.99 | <0.0001 | 0.53 | |||||
| SBWI group | 40.2 (39.2, 41.1) | −4.7 (−5.2, −4.2) | −4.7 (−5.2, −4.2) | −4 (−4.6, −3.5) | −3.5 (−4.1, −3) | |||
| EBWI group | 40 (39, 40.9) | −4.1 (−4.6, −3.6) | −3.7 (−4.2, −3.2) | −3.2 (−3.8, −2.7) | −2.4 (−3, −1.9) | |||
| Difference | −0.6 (−1.3, 0.1) | −1 (−1.7, −0.3) | −0.8 (−1.6, −0.1) | −1.1 (−1.9, −0.3) | ||||
| Bone Mass, kg | >0.99 | <0.0001 | >0.99 | |||||
| SBWI group | 3008.5 (2957.5, 3059.6) | −13.4 (−19, −7.8) | −15.5 (−21.4, −9.6) | −17.4 (−23.5, −11.3) | −18.7 (−25, −12.4) | |||
| EBWI group | 3033.2 (2982.6, 3083.8) | −10 (−15.6, −4.4) | −8.7 (−14.6, −2.8) | −8 (−14.2, −1.9) | −9.2 (−15.6, −2.9) | |||
| Difference | −3.4 (−11.3, 4.6) | −6.8 (−15.1, 1.5) | −9.4 (−18, −0.7) | −9.5 (−18.4, −0.5) | ||||
| Total Body Bone Mineral Density, g/cm2 | >0.99 | <0.001 | 0.54 | |||||
| SBWI group | 1.3 (1.3, 1.4) | −0.005 (−0.007, −0.002) | −0.006 (−0.009, −0.003) | −0.007 (−0.010, −0.004) | −0.005 (−0.008, −0.002) | |||
| EBWI group | 1.3 (1.3, 1.4) | −0.001 (−0.003, 0.002) | −0.002 (−0.004, 0.001) | −0.002 (−0.005, 0.001) | 0.002 (−0.002, 0.005) | |||
| Difference | −0.004 (−0.008, −0.000) | −0.004 (−0.008, −0.000) | −0.005 (−0.009, −0.001) | −0.006 (−0.011, −0.002) | ||||
| Cardiorespiratory Fitness (ml/kg/min) | >0.99 | <0.0001 | >0.99 | |||||
| SBWI group | 27.3 (26.4, 28.1) | 3.8 (3.2, 4.4) | 3.1 (2.4, 3.7) | 3.1 (2.4, 3.7) | 2 (1.3, 2.6) | |||
| EBWI group | 27.3 (26.5, 28.2) | 3.9 (3.3, 4.5) | 2.3 (1.6, 2.9) | 2.6 (1.9, 3.3) | 1.7 (1, 2.4) | |||
| Difference | −0.1 (−0.9, 0.8) | 0.8 (−0.1, 1.7) | 0.5 (−0.4, 1.4) | 0.2 (−0.7, 1.2) | ||||
*
Model includes group (fixed), recruitment period (random), time (categorical, fixed), race (fixed), sex (fixed), time and group interaction (fixed), time and recruitment period (random).
**
P-values are adjusted for multiple outcomes using Holm’s approach, except for the definitive primary outcome of weight, and the exploratory outcome percent change in body weight.
***
P-values for comparison at specific time points are adjusted for multiple testing across time points using Holm’s method and only provided when there was a significant time and group interaction.
****
Primary outcome.
*****
Post-hoc analysis of a non-pre-specified primary or secondary outcome.
******
Percent body fat excluding bone mass.