TABLE 3.
Within-person variability as measured by standard deviation of mood symptoms and pain stratified by intervention group pre- and post-intervention
| Outcomea Within-Person Variability in… | Diet H3-L6 (N=33)b Control (N=37)b | Pre | Postc | Within Group P-value | Between Groups (Postc) P-value | |
|---|---|---|---|---|---|---|
| Mood | H3-L6 | Mean (SD) | 17.27 (5.40) | 13.49 (8.47) | <0.01* | 0.17 |
| Range Min-Max | 4.66–29.96 | 2.12–44.55 | ||||
| Control | Mean (SD) | 17.24 (8.14) | 17.19 (13.14) | 0.99 | ||
| Range Min-Max | 2.12–36.79 | 1.88–70.71 | ||||
| Energy | H3-L6 | Mean (SD) | 18.90 (5.94) | 15.28 (9.96) | 0.026* | 0.44 |
| Range Min-Max | 8.31–32.01 | 3.06–55.15 | ||||
| Control | Mean (SD) | 19.84 (5.97) | 17.03 (8.35) | 0.022* | ||
| Range Min-Max | 8.40–29.27 | 0–35.56 | ||||
| Speed of Thoughts | H3-L6 | Mean (SD) | 18.29 (7.40) | 13.43 (9.82) | 0.006* | 0.22 |
| Range Min-Max | 2.57–35.27 | 0–45.25 | ||||
| Control | Mean (SD) | 18.41 (8.78) | 17.02 (13.95) | 0.43 | ||
| Range Min-Max | 0.71–32.41 | 1.56–62.93 | ||||
| Impulsivity (thoughts) | H3-L6 | Mean (SD) | 19.09 (10.03) | 15.40 (12.68) | 0.17 | 0.97 |
| Range Min-Max | 0.2–37.85 | 0–58.69 | ||||
| Control | Mean (SD) | 18.32 (8.38) | 15.49 (10.74) | 0.11 | ||
| Range Min-Max | 0–35.68 | 0–41.79 | ||||
| Impulsivity (actions) | H3-L6 | Mean (SD) | 16.30 (7.82) | 12.84 (10.29) | 0.13 | 0.56 |
| Range Min-Max | 0.4–29.73 | 0–42.43 | ||||
| Control | Mean (SD) | 15.56 (7.98) | 11.35 (10.40) | 0.03* | ||
| Range Min-Max | 0.71–38.58 | 0–45.90 | ||||
| Anxiety | H3-L6 | Mean (SD) | 20.73 (7.89) | 17.01 (9.69) | 0.04* | 0.29 |
| Range Min-Max | 4.48–38.36 | 4.95–52.33 | ||||
| Control | Mean (SD) | 22.83 (9.59) | 19.97 (12.91) | 0.19 | ||
| Range Min-Max | 3.92–48.08 | 3.49–64.35 | ||||
| Irritability | H3-L6 | Mean (SD) | 22.06 (8.53) | 19.06 (12.62) | 0.16 | 0.64 |
| Range Min-Max | 5.13–39.45 | 1.41–60.81 | ||||
| Control | Mean (SD) | 24.20 (9.97) | 20.61 (14.36) | 0.10 | ||
| Range Min-Max | 7.42–41.74 | 1.94–70.71 | ||||
| Pain | H3-L6 | Mean (SD) | 13.78 (6.52) | 9.43 (6.24) | 0.002* | 0.21 |
| Range Min-Max | 2.97–28.18 | 0–24.35 | ||||
| Control | Mean (SD) | 14.67 (9.23) | 11.72 (8.46) | 0.11 | ||
| Range Min-Max | 0–35.33 | 0–33.45 |
Outcomes were measured twice per day on a visual analog scale (Range 0–100) using an Ecological Momentary Assessment paradigm. Exact question text provided in supplement.
Phone data for the Mood and Stress survey from 12 of the 82 randomized participants could not be used in this analysis. N = 2 participants did not log any usable phone date during the Baseline period (prior to week 0 randomization visit). N = 9 participants did not log any usable phone data during the follow-up period (after week 0 randomization visit), and N = 1 participant had no usable phone data for the study due to the malfunctioning date-time mechanism on the phone that they were provided. Therefore, N = 70 participants were included in the EMA analysis utilizing Mood and Stress surveys.
Note that ‘Pre’ data refers to all usable phone surveys logged between the participant’s date of enrollment and their date of randomization at week 0 visit (total of 1711 phone surveys included here). Note that ‘Post’ data in this table references only phone survey data logged between each participant’s last two attended study visits during Phase 1 of the trial (total of 938 phone surveys included here). For example, if the participant completed Phase 1, week 12 visit would be considered their last attended study visit. Therefore, the data used for this table would have included all phone surveys logged between their week 10 visit and their week 12 visit. There was one participant who skipped two consecutive study visits (week 8 and week 10). Any usable phone data logged between their week 6 visit and their week 12 visit was assigned to their last visit (week 12). There were two participants who skipped their week 10 visit, therefore any usable phone data logged between their week 8 visit and their week 12 visit was assigned to their last visit (week 12). There was one participant who skipped their week 2 visit, therefore any usable phone data logged between their week 0 visit and their week 4 visit was assigned to their last visit (week 4). The smallest and largest number of surveys attributed to week 0 visit for a participant in either group were 2 and 55, respectively. The smallest and largest number of surveys attributed to any last attended visit for a participant in either group during Phase 1 were 1 and 36, respectively. This table utilizes a total of 2649 phone surveys. Group comparisons between the diet groups were performed using two-sample t-tests or Wilcoxon rank-sum tests, as appropriate. Within each diet group, the pre-versus post-intervention comparisons were conducted using paired t-tests or Wilcoxon signed-rank tests, as appropriate.
p < 0.05.