The Effect of a Lifestyle Intervention Program Using a Mobile Application for Adults with Metabolic Syndrome, versus the Effect of a Program Using a Booklet: A Pilot Randomized Controlled Trial

Figures & data

Figure 1 Study flow chart.

Table 1 Demographic and Clinical Characteristics of Participants

Participants’ Characteristics	All (N=77) N (%)	App Group (N=38) N (%)	Booklet Group (N=39) N (%)	p-value
Age, mean (SD)	58.95 (7.10)	57.42 (6.43)	60.45 (7.49)	0.061
Gender				0.139
Male	34 (44.2)	20 (52.6)	14 (35.9)
Female	43 (55.8)	18 (47.4)	25 (64.1)
Height (cm), mean (SD)	1.62 (0. 89)	1.64 (0.09)	1.6 (0.08)	0.024*
Weight (kg), mean (SD)	71.38 (15.24)	73.61 (15.66)	69.2 (14.69)	0.206
BMI, mean (SD)	27.02 (4.21)	27.1 (4.41)	26.95 (4.07)	0.876
Waist (cm), mean (SD)	96 (10.35)	95.89 (9.87)	96.11 (10.92)	0.926
Hip (cm), mean (SD)	100.94 (7.3)	101.24 (7.42)	100.65 (7.27)	0.725
Systolic blood pressure (mmHg), mean (SD)	133.17 (16.45)	133.39 (15.65)	132.9 (17.39)	0.906
Diastolic blood pressure (mmHg), mean (SD)	83.6 (14.73)	84.34 (12.16)	82.87 (17)	0.664
Heart rate, mean (SD)	72 (13.98)	73.16 (10.9)	72.31 (13.37)	0.754
Fasting blood glucose (mmo/L), mean (SD)	5.86 (1.57)	5.54 (1.15)	6.16 (1.85)	0.082
Total cholesterol (mmo/L), mean (SD)	4.99 (0.86)	4.96 (0.82)	5.01 (0.9)	0.812
HDL cholesterol (mmo/L), mean (SD)	1.39 (0.34)	1.41 (0.34)	1.37 (0.36)	0.669
LDL cholesterol (mmo/L), mean (SD)	2.66 (0.8)	2.50 (1.00)	2.62 (0.88)	0.694
Education level				0.018*
Primary or below	12 (15.6)	2 (5.3)	10 (25.7)
Secondary	46 (59.7)	22 (57.9)	24 (61.5)
Tertiary	19 (24.7)	14 (36.8)	5 (12.8)
Marital status				0.621
Married	55 (78.3)	29 (76.3)	26 (66.7)
Not married	9 (21.7)	4 (10.5)	5 (12.8)
Separated/divorced/widow	13 (16.9)	5 (13.2)	8 (20.5)
Financial status				0.203
Good	16 (20.8)	11 (29)	5 (12.8)
Average	58 (75.3)	26 (68.4)	32 (82.1)
Poor	3 (3.9)	1 (2.6)	2 (5.1)
Residential status				0.591
Live alone	14 (18.2)	6 (16)	8 (20.5)
Live with family	63 (81.8)	32 (84)	31 (79.5)
Smoking				0.308
Yes	1 (1.3)	1 (2.6)	0 (0)
No	76 (98.7)	37 (97.4)	39 (100)
Employment status				0.664
Full-time	32 (41.6)	15 (39.5)	17 (43.6)
Part-time	9 (11.7)	6 (15.8)	3 (7.7)
Housewife	12 (16.9)	7 (18.4)	5 (15.4)
Retired	23 (29.9)	10 (26.3)	13 (33.3)
Exercise habit				0.817
Yes	62 (80.5)	31 (81.6)	31 (79.5)
No	13 (19.5)	7 (18.4)	8 (20.5)

Note: Significant * p<0.05.

Table 2 Baseline Outcome Measures for Participants

Baseline Measures	All (N=77) N (%)	App Group (N=38) N (%)	Booklet Group (N=39) N (%)	p-value
	Mean (SD)	Mean (SD)	Mean (SD)
Total exercise time per week Mean (SD)	127.99 (96.11)	137.5 (100.21)	118.72 (92.3)	0.395
Godin weekly leisure time activity score (GSLTPA) Mean (SD)	16.45 (11.34)	16.13 (10.68)	16.76 (12.08)	0.811
Exercise self-efficacy	37.14 (14.65)	34.61 (13.26)	39.61 (15.67)	0.134

Table 3 Mean and Standard Deviation of Outcomes

Mean (SD) of All Outcomes	App Group Mean (SD)	Booklet Group Mean (SD)	Cohen’s d
Weight (kg)
T1	72.47 (2.60)	70.14 (2.15)
T3	71.20 (2.53)	69.91 (2.11)	−0.607
BMI
T1	27.62 (0.92)	27.64 (0.76)
T3	27.19 (0.90)	27.59 (0.75)	−0.387
Waist circumference
T1	97.69 (2.19)	97.91 (1.95)	−0.326
T3	96.18 (2.23)	98.21 (1.88)
Systolic blood pressure (mmHg)
T1	137.31 (2.85)	135.95 (2.65)	−0.348
T3	131.92 (2.81)	133.75 (2.57)
Diastolic blood pressure (mmHg)
T1	83.24 (2.52)	81.97 (2.72)	0.053
T3	84.50 (2.31)	81.56 (2.06)
Fasting blood glucose
T1	5.42 (0.21)	6.02 (0.23)	0.316
T3	5.37 (0.18)	5.59 (0.14)
Total cholesterol
T1	5.00 (0.18)	4.96 (0.16)	0.078
T3	5.01 (0.22)	4.95 (0.20)
Triglyceride
T1	1.89 (0.20)	1.83 (0.16)	−0.030
T3	1.88 (0.19)	1.89 (0.20)
HDL cholesterol
T1	1.40 (0.06)	1.36 (0.06)	0.039
T3	1.38 (0.06)	1.31 (0.07)
LDL cholesterol
T1	2.43 (0.25)	2.52 (0.20)	0.142
T3	2.51 (0.27)	2.51 (0.23)
Total exercise time per week (minutes)
T1	123.01 (19.02)	100.83 (13.95)
T2	183.34 (23.10)	106.86 (16.08)	0.782
T3	161.35 (16.96)	91.97 (17.79)	0.306
Total amount of exercise (GSLTPA score per week)
T1	18.16 (2.76)	17.92 (2.35)
T2	25.56 (2.98)	19.38 (2.35)	0.470
T3	29.10 (3.59)	20.27 (2.64)	0.571
Self-efficacy for exercise (SEE) range from 0 to 90
T1	30.82 (2.38)	36.12 (2.45)
T2	36.22 (2.63)	33.60 (2.38)	0.669
T3	40.54 (2.89)	35.91 (2.45)	0.838

Table 4 Generalized Estimation Equation (GEE) Models for the Comparison of the Repeated Measures Outcome Variables Between the Two Groups

	β	95% CI		p
Weight (kg)
Group	2.358	−4.16	8.88	0.478
Month 3	−0.217	−0.66	0.23	0.337
Group*Month 3	−1.069	−1.90	−0.24	0.012*
BMI
Group	−0.021	−1.75	1.71	0.981
Month 3	−0.06	−0.27	0.16	0.620
Group*Month 3	−0.371	−0.70	−0.04	0.026*
Waist (cm)
Group	−0.223	−4.69	4.24	0.922
Month 3	0.296	−1.23	1.82	0.703
Group*Month 3	−1.801	−4.26	0.66	0.151
Waist–hip ratio
Group	−0.003	−0.03	0.23	0.834
Month 3	0.001	−0.17	0.02	0.924
Group*Month 3	−0.017	−0.04	0.01	0.210
Systolic blood pressure
Group	1.357	−5.84	8.56	0.712
Month 3	−2.199	−5.60	1.20	0.205
Group*Month 3	−3.185	−9.19	2.82	0.299
Diastolic blood pressure
Group	1.246	−5.30	7.79	0.709
Month 3	−0.403	−5.00	4.20	0.864
Group*Month 3	1.843	−4.36	8.05	0.560
Fasting blood glucose
Group	−0.596	−1.32	0.12	0.105
Month 3	−0.426	−0.84	−0.01	0.045*
Group*Month 3	0.374	−0.12	0.87	0.140
Total cholesterol
Group	0.039	−0.36	0.44	0.850
Month 3	−0.013	−0.29	0.26	0.926
Group*Month 3	0.027	−0.30	0.35	0.871
Triglyceride
Group	0.053	−0.39	0.50	0.813
Month 3	0.060	−0.24	0.36	0.692
Group*Month 3	−0.064	−0.47	0.34	0.756
HDL cholesterol
Group	0.042	−0.12	0.21	0.610
Month 3	−0.05	−0.22	0.12	0.556
Group*Month 3	0.022	−0.15	0.20	0.801
LDL cholesterol
Group	−0.093	−0.52	0.33	0.669
Month 3	−0.009	−0.25	0.23	0.942
Group*Month 3	0.089	−0.34	0.52	0.686
Total Exercise time per week
Group	22.312	−23.87	68.50	0.344
Month 1	6.026	−16.09	28.14	0.593
Month 3	−8.858	−46.21	28.50	0.642
Group*Month 1	54.476	18.63	90.33	0.003**
Group*Month 3	47.377	−10.60	105.23	0.067
Total amount of exercise (GSLTPA score)
Group	0.25	−4.84	5.34	0.924
Month 1	1.476	−2.17	5.10	0.430
Month 3	2.357	−2.22	6.94	0.313
Group*Month 1	5.933	0.59	11.27	0.029*
Group*Month 3	8.584	0.72	16.45	0.032*
Self-efficacy for Exercise (SEE)
Group	−5.294	−11.94	1.35	0.119
Month 1	−2.522	−6.47	1.43	0.211
Month 3	−0.208	−4.08	3.66	0.916
Group*Month 1	7.919	2.80	13.04	0.002**
Group*Month 3	10.62	4.09	15.77	0.001**

Notes: Time points (month 1, and month 3, with month 0 as reference), time points and groups interaction terms (group*month 1, and group*month 3,) were showed for the GEE models. Variables adjusted in the GEE models: education. All statistical tests were two-sided and a p-value <0.05 was considered statistically significant. Significant *p<0.05, **p<0.001.