Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study

Figures & data

Table 1 Baseline Characteristics of Study Participants in the Health Behaviors (HB) and Standard of Care (SOC) Groups^a

Characteristic	Health Behaviors	Standard of Care	p-value^b
n	29	15
Age (years)	38.0 ± 1.1	41.1 ± 2.3	0.19
Female (%)	26 (89.7%)	15 (100%)	0.54
MS duration (years)	0.29 ± 0.04	0.34 ± 0.08	0.57
BMI	25.80 ± 1.0	24.3 ± 1.0	0.32
Race
White	23 (79.3%)	13 (86.7%)	>0.99
Black	1 (3.5%)	0
Latin or Hispanic	1 (3.5%)	0
Two or more races	2 (6.9%)	1 (6.7%)
Unknown or Not Reported	2 (6.9%)	1 (6.7%)
MSQOL54 - Mental	3.85 ± 0.11	4.08 ± 0.21	0.27
MSQOL54 - Physical	2.78 ± 0.04	2.75 ± 0.06	0.63
IPAQ – Total MET	12950 ± 3518	10035 ± 2702	0.58
IPAQ - Moderate MET	10403 ± 2706	6016 ± 1608	0.27
IPAQ -Vigorous MET	1953 ± 774	2976 ± 1485	0.50
IPAQ - Walking MET	594 ± 282	1043 ± 597	0.44
HADS - Anxiety	4.59 ± 0.65	3.60 ± 0.95	0.39
HADS - Depression	8.38 ± 0.64	7.47 ± 1.41	0.50
FSS	3.58 ± 0.26	3.51 ± 0.58	0.90
Total MFIS	32.6 ± 3.56	31.9 ± 7.78	0.93
MFIS - Physical	12.8 ± 1.59	12.8 ± 3.24	0.99
MFIS - Cognitive	17.3 ± 1.90	16.5 ± 3.95	0.82
MFIS - Psychosocial	2.45 ± 0.40	2.60 ± 0.79	0.85
Total PDQ	27.5 ± 2.66	24.9 ± 4.14	0.58
PDQ - Attention	8.59 ± 0.79	8.00 ± 1.10	0.67
PDQ - Retromemory	6.31 ± 0.77	5.67 ± 1.25	0.65
PDQ - Promemory	5.48 ± 0.66	4.73 ± 0.88	0.51
PDQ - Planning	7.10 ± 0.73	6.47 ± 1.44	0.66

Notes: ^aData are shown as mean ± SEM or n (%). ^bSignificance determined using Pearson’s chi-square test for categorical variables or two-sample t-test for continuous variables.

Abbreviations: BMI, body mass index; FSS, Fatigue Severity Scale; HADS, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; MFIS, Modified Fatigue Impact Scale; PDQ, Perceived Deficits Questionnaire.

Figure 1 Diagram illustrating participant recruitment and study flow for health behaviors (HB) intervention and standard of care (SOC) groups. *An additional breakdown of ineligibility criteria is available in the Supplemental Material. Reasons for ineligibility or exclusion may not add up to the value of ineligible or excluded because some participants were found ineligible or were excluded for multiple reasons. ^†Recruitment stopped due to COVID-19 pandemic.

Table 2 Baseline and 12-Month Outcome Means and Magnitude of Mean Change for the Health Behaviors (HB) Intervention and Standard of Care (SOC) Groups

Outcomes	Health Behaviors				Standard of Care				HB vs SOC	Effect Size	Non-Inferiority Analysis
	Baseline Mean (±SEM)^a	12-months Mean (±SEM)^a	MeanΔ (95% CI)^b	p-value^c	Baseline Mean (±SEM)^a	12-months Mean (±SEM)^a	MeanΔ (95% CI)^b	p-value^c	p-value^c	d^d	p-value^e
MSQOL54 - Mental	3.85± 0.11	4.08± 0.13*	0.24(0.01, 0.47)	0.04	4.08± 0.21	4.34± 0.14	0.26(−0.03, 0.55)	0.08	0.90	0.05	0.21
MSQOL54 - Physical	2.78± 0.04	2.83± 0.04	0.05(−0.05, 0.14)	0.35	2.75± 0.06	2.87± 0.04*	0.12(0.00, 0.24)	0.049	0.15	−0.22	0.02
IPAQ - Total MET	12950± 3518	7762± 1932	0.60(0.36, 1.00)	0.05	10035± 2702	7632± 2087	0.76(0.41, 1.42)	0.39	0.56	−0.26	-
IPAQ - Moderate MET	10403± 2706	6670± 1837	0.64(0.36, 1.14)	0.13	6016± 1608	4652± 1118	0.77(0.39, 1.55)	0.47	0.69	−0.23	-
IPAQ - Vigorous MET	1953± 774	580± 299**	0.30(0.12, 0.72)	0.007	2976± 1485	1883± 1767	0.63(0.18, 2.26)	0.48	0.34	−0.31	-
IPAQ - Walking MET	594± 282	512± 218	0.86(0.52, 1.41)	0.55	1043± 597	1097± 505	1.05(0.31, 3.59)	0.94	0.77	−0.04	-
HADS - Anxiety	8.38± 0.64	6.63± 0.84*	−1.75(−3.08,-0.43)	0.009	7.47± 1.41	6.54± 1.07	−1.50(−4.36, 1.36)	0.36	0.49	−0.43	0.02
HADS - Depression	4.59± 0.65	3.54± 0.75	−1.04(−2.24, 0.16)	0.09	3.60± 0.95	2.69± 0.94*	−0.93(−2.91,-1.05)	0.009	0.85	0.12	<0.0001
FSS	3.58± 0.26	3.22± 0.37	−0.36(−0.94, 0.22)	0.22	3.51± 0.58	3.23± 0.60	−0.28(−0.86, 0.30)	0.34	0.85	−0.15	0.02
Total MFIS	32.6± 3.56	25.3± 4.28*	−7.26(−13.3,-1.18)	0.02	31.9± 7.78	24.4± 6.05	−7.48(−16.0, 1.06)	0.09	0.97	−0.14	0.15
MFIS - Physical	12.8± 1.59	10.2± 1.90	−2.55(−5.76, 0.66)	0.12	12.8± 3.24	8.54± 2.95**	−4.26(−7.41,-1.11)	0.008	0.46	0.03	-
MFIS - Cognitive	17.3± 1.90	12.8± 2.17**	−4.59(−7.56,-1.63)	0.002	16.5± 3.95	13.9± 2.68	−2.54(−7.78, 2.69)	0.34	0.50	−0.30	-
MFIS - Psychosocial	2.45± 0.40	2.33± 0.43	−0.11(−0.91, 0.68)	0.78	2.60± 0.79	1.92± 0.70	−0.68(−1.54, 0.19)	0.13	0.35	0.07	-
Total PDQ	27.5± 2.66	21.3± 3.21**	−6.23(−10.1,-2.4)	0.001	24.9± 4.14	24.7± 4.83	−0.17(−6.25, 5.90)	0.96	0.10	−0.47	0.01
PDQ - Attention	8.59± 0.79	6.63± 0.84**	−1.96(−3.18,-0.74)	0.002	8.00± 1.10	7.62± 1.36	−0.38(−2.27, 1.50)	0.69	0.16	−0.30	-
PDQ - Retromemory	6.31± 0.77	5.25± 0.94	−1.06(−2.32, 0.20)	0.10	5.67± 1.25	6.15± 1.38	0.49(−1.40, 2.38)	0.61	0.20	−0.45	-
PDQ - Promemory	5.48± 0.66	4.33± 0.75*	−1.15(−2.16,-0.14)	0.03	4.73± 0.88	4.54± 0.87	−0.19(−1.71, 1.32)	0.80	0.32	−0.36	-
PDQ - Planning	7.10± 0.73	5.04± 0.84***	−2.06(−3.09,-1.04)	<0.0001	6.47± 1.44	6.38± 1.43*	−0.08(−1.75, 1.58)	0.92	0.048	−0.59	-

Notes: Numerals in bold indicate statistically significant values (p < 0.05). ^aAll values shown in mean ± SEM. ^bMagnitude of mean change from baseline to 12-months. ^c Significance was determined using a two-sample t-test. ^dA Cohen’s d score of zero means that the treatment and comparison group do not differ significantly in their effects; greater than or less than zero indicates the degree to which one treatment is more efficacious than the other. The conventional rule to for classifying Cohen’s d absolute value is 0.2 as small, 0.5 as medium, and 0.8 as large. ^eNon-inferiority analysis p-value, based on respective outcome margins. Within-group statistical significance compared to baseline values indicated by * for (p ≤ 0.05), ** for (p ≤ 0.01), and *** for (p ≤ 0.001).

Abbreviations: FSS, Fatigue Severity Scale; HADS, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; MSQOL54, Multiple Sclerosis Quality of Life 54 Questionnaire; MFIS, Modified Fatigue Impact Scale; PDQ, Perceived Deficits Questionnaire.