Skip to main content

Table 2 Change over Time in Outcomes by Treatment Group 1

From: Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

  

P-values

Standard Care

In-person

mHealth

In-person vs SC

mHealth vs SC

Change in ALSFRS-R at month 3

−1.9 (− 3.4, − 0.3)

−2.1 (− 3.8, − 0.5)

− 2.0 (− 3.8, − 0.3)

0.80

0.88

Change in ALSFRS-R at month 6

−5.2 (− 7.6, − 2.9)

−5.8 (− 8.2, − 3.4)

− 2.6 (− 5.1, − 0.1)

0.74

0.13

Change in PROMIS QOL at month 3

−2.1 (− 4.0, − 0.2)

− 1.0 (− 2.9, 0.8)

0.3 (− 1.7, 2.2)

0.42

0.08

Change in PROMIS QOL at month 6

−2.8 (− 5.2, − 0.5)

−2.3 (− 4.6, − 0.1)

−1.9 (− 4.4, 0.5)

0.77

0.59

Change in Weight at month 3 (kg)

−0.0 (−1.4, 1.3)

− 0.1 (− 1.5, 1.3)

0.3 (− 1.1, 1.8)

0.95

0.70

Change in Weight at month 6 (kg)

− 1.2 (− 3.2, 0.7)

− 0.1 (− 2.1, 2.0)

−0.2 (− 2.4, 2.1)

0.41

0.47

Change in % Calories at month 3

−0.6 (− 10.4, 9.2)

6.8 (− 2.5, 16.0)

12.2 (2.5, 21.8)

0.26

0.06

Change in % Calories at month 6

3.5 (−7.9, 14.9)

7.6 (−3.9, 19.2)

1.0 (− 10.7, 12.6)

0.59

0.75

Change in total kCal at month 3

−35.3 (− 368.8, 298.1)

250.3 (− 65.2, 565.8)

308.2 (− 21.2, 637.6)

0.21

0.14

Change in total kCal at month 6

83.9 (− 298.7, 466.4)

78.2 (− 295.5, 451.8)

−33.7 (− 424.5, 357.1)

0.98

0.66

  1. 1 Change over time from baseline according to treatment group, adjusted for sex and change in BMI from diagnosis to baseline. Parameter estimates of change from baseline and 95% confidence intervals are shown. ALSFRS-R is shown in units, PROMIS sf v1.1 is shown in units, higher scores are better. Change in % Calories = change in self-reported calories consumed as a percent of recommended calories according to the Kasarskis equation [23]; SC=Standard Care