Table 3.
Weight change at weeks 12 and 39.
| DCR | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 12a | Change (Baseline to Week 12) | P for Change (Baseline to Week 12)b | Week 39c | Change (Baseline to Week 39) | P for Change (Baseline to Week 39)b | ||||
| N | Mean (SD) | N | Mean (SD) | Mean (SD) | N | Mean (SD) | Mean (SD) | |||
| Clinic Weight, kg | 40 | 94.2 (18.7) | 27 | 88.9 (19.7) | −5.1 (3.2) | <.0001 | ||||
| DXA Weight, kg | 40 | 93.4 (18.4) | 23 | 87.4 (19.2) | −3.6 (3.3) | <.0001 | 30 | 88.6 (18.6) | −4.3 (5.3) | <.0001 |
| Fat Mass, kg | 40 | 40.1(11.0) | 23 | 37.0 (12.5) | −2.1 (2.6) | <.0001 | 30 | 36.4 (13.2) | −2.6 (4.4) | <.001 |
| Lean Mass, kg | 40 | 52.1 (9.1 | 23 | 49.6 (9.0) | −1.1 (1.8) | 0.001 | 30 | 51.1 (8.3) | −1.5 (1.8) | <.001 |
| E-TRE+DCR | ||||||||||
| Clinic Weight, kg | 39 | 97.0 (18.4) | 33 | 91.2 (18.6) | −6.2 (4.1) | <.0001 | ||||
| DXA Weight, kg | 41 | 96.1 (18.1) | 24 | 90.2 (19.0) | −4.4 (2.6) | <.0001 | 30 | 90.1 (19.8) | −4.9 (5.3) | <.0001 |
| Fat Mass, kg | 41 | 41.3 (11.2) | 24 | 38.5 (11.6) | −2.8 (1.8) | <.0001 | 30 | 36.7 (11.8) | −3.5 (4.0) | <.0001 |
| Lean Mass, kg | 41 | 53.7 (9.8) | 24 | 50.7 (9.7) | −1.5 (1.4) | <.0001 | 30 | 52.5 (10.4) | −1.2 (2.3) | 0.003 |
a
Due to COVID-related interruptions to the intervention, Week 12 DXA scans were not performed in cohort 3. Cohort 3 is excluded from Week 12 DXA variables.
b
Random intercept mixed models with unstructured covariance matrices were used to test for significant within-group and between-group changes. Fixed effects included randomized group, time, and a group*time interaction. P-values presented in this table were computed using contrasts.
c
Week 39 values for clinic weights were not included due to missing data
SD, standard deviation