Table 1
Schedule of messages’ content for the intervention group.
| DAY | TASK | DAY | TASK | DAY | TASK | DAY | TASK |
|---|---|---|---|---|---|---|---|
| 1 | Video 1 | 22 | Activity 6 | 43 | Day off | 64 | RM 22 |
| 2 | RM 1 | 23 | RM 8 | 44 | Video 9 | 65 | Activity 21 |
| 3 | Activity 1 | 24 | Day off | 45 | RM 15 | 66 | Day off |
| 4 | Day off | 25 | Video 6 | 46 | Activity 14 | 67 | Video 12 |
| 5 | Video 2 | 26 | RM 9 | 47 | RM 16 | 68 | RM 23 |
| 6 | RM 2 | 27 | Activity 7 | 48 | Activity 15 | 69 | Activity 22 |
| 7 | Activity 2 | 28 | RM 10 | 49 | RM 17 | 70 | RM 24 |
| 8 | Day off | 29 | Activity 8 | 50 | Activity 16 | 71 | Activity 23 |
| 9 | Video 3 | 30 | Day off | 51 | Day off | 72 | Day off |
| 10 | RM 3 | 31 | Video 7 | 52 | Video 10 | 73 | Video 13 |
| 11 | Activity 3 | 32 | RM 11 | 53 | RM 18 | 74 | RM 25 |
| 12 | Day off | 33 | Activity 9 | 54 | Activity 17 | 75 | Activity 24 |
| 13 | Video 4 | 34 | Activity 10 | 55 | RM 19 | 76 | RM 26 |
| 14 | RM 4 | 35 | RM 12 | 56 | Day off | 77 | Day off |
| 15 | Activity 4 | 36 | Activity 11 | 57 | Video 11 | 78 | Video 14 |
| 16 | RM 5 | 37 | Activity 12 | 58 | RM 20 | 79 | RM 27 |
| 17 | Day off | 38 | Day off | 59 | Activity 18 | 80 | RM 28 |
| 18 | Video 5 | 39 | Video 8 | 60 | RM 21 | 81 | Day off |
| 19 | RM 6 | 40 | RM 13 | 61 | Activity 19 | 82 | Video 15 |
| 20 | Activity 5 | 41 | Activity 13 | 62 | Day off | 83 | RM 29 |
| 21 | RM 7 | 42 | RM 14 | 63 | Activity 20 | 84 | Activity 25 |
[i] RM: reflection message.
Table 2
Baseline characteristics.
| INTERVENTION (N = 51) | CONTROL (N = 49) | p-VALUE | |
|---|---|---|---|
| Gender, n (%) | 0.0111 | ||
| Male | 9 (17.6%) | 20 (40.8%) | |
| Female | 42 (82.4%) | 29 (59.2%) | |
| Diabetes, n (%) | 0.7281 | ||
| No | 37 (72.5%) | 34 (69.4%) | |
| Yes | 14 (27.5%) | 15 (30.6%) | |
| Physical activities, n (%) | 0.4271 | ||
| No | 23 (45.1%) | 24 (49.0%) | |
| Yes—irregular | 16 (31.4%) | 10 (20.4%) | |
| Yes—regular | 12 (23.5%) | 15 (30.6%) | |
| Marital status, n (%) | 0.1932 | ||
| Single | 10 (19.6%) | 11 (22.4%) | |
| Married | 28 (54.9%) | 18 (36.7%) | |
| Living together | 6 (11.8%) | 4 (8.2%) | |
| Divorced | 4 (7.8%) | 10 (20.4%) | |
| Widow | 3 (5.9%) | 6 (12.2%) | |
| Smoking, n (%) | 0.7941 | ||
| Never | 39 (76.5%) | 35 (71.4%) | |
| Former | 6 (11.8%) | 8 (16.3%) | |
| Current | 6 (11.8%) | 6 (12.2%) | |
| Religion, n (%) | 0.8852 | ||
| Protestant | 22 (43.1%) | 21 (42.9%) | |
| Catholic | 20 (39.2%) | 22 (44.9%) | |
| Spiritist | 2 (3.9%) | 1 (2.0%) | |
| Others | 7 (13.7%) | 5 (10.2%) | |
| Alcohol intake, n (%) | 0.2991 | ||
| No | 36 (70.6%) | 39 (79.6%) | |
| Yes | 15 (29.4%) | 10 (20.4%) | |
| Age | 0.2043 | ||
| Mean (SD) | 55.8 (10.6) | 58.8 (12.3) | |
| BMI | 0.0433 | ||
| Mean (SD) | 32.0 (5.9) | 29.7 (5.4) | |
| Office SBP | 0.4703 | ||
| Mean (SD) | 130.1 (15.3) | 127.9 (15.1) | |
| Office DBP | 0.4183 | ||
| Mean (SD) | 79.6 (10.9) | 77.9 (8.8) | |
| Central SBP | 0.2203 | ||
| Mean (SD) | 117.5 (12.9) | 114.4 (12.6) | |
| Central DBP | 0.9603 | ||
| Mean (SD) | 81.8 (10.6) | 81.9 (9.5) | |
| HBPM SBP | 0.7653 | ||
| Mean (SD) | 122.5 (10.8) | 123.3 (12.6) | |
| HBPM DBP | 0.7653 | ||
| Mean (SD) | 80.6 (9.6) | 80.1 (7.3) | |
| PWV | 0.3023 | ||
| Mean (SD) | 8.0 (1.5) | 8.3 (1.7) | |
| FMD | 0.7733 | ||
| Mean (SD) | 9.8 (5.1) | 10.2 (6.1) |
[i] 1P-value from Chi-Square test;2P-value from Fisher Exact test;3P-value from unpaired two-samples t-test with equal variance.
BMI—body mass index, SBP—systolic blood pressure, DBP—diastolic blood pressure, HBPM—home blood pressure monitoring, PWV—pulse wave velocity, FMD—flow mediated dilation.
Figure 1
Flow diagram of randomized patients, beginning to end of the study.
Table 3
Study outcomes: within group comparisons between first and final visits.
| OUTCOME | SPIRITUALITY-BASED INTERVENTION GROUP (G1) n = 39 | CONTROL GROUP (G2) n = 36 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MEAN | SD | LOWER 95%CI | UPPER 95%CI | P-VALUE | MEAN | SD | LOWER 95%CI | UPPER 95%CI | P-VALUE | |
| Office SBP (V2) | 121.37 | 13.09 | 126.63 | 15.55 | ||||||
| Office SBP (V1) | 128.97 | 15.60 | 127.18 | 15.30 | ||||||
| Office SBP (V2-V1) | –7.60 | –11.72 | –3.48 | < 0.001 | –0.56 | –6.40 | 5.29 | 0.848 | ||
| Office DBP (V2) | 80.58 | 10.83 | 81.65 | 8.39 | ||||||
| Office DBP (V1) | 79.39 | 10.08 | 77.28 | 9.08 | ||||||
| Office DBP (V2-V1) | 1.19 | –1.72 | 4.10 | 0.412 | 4.38 | 1.84 | 6.92 | 0.001 | ||
| Central SBP (V2) | 113.42 | 11.79 | 115.12 | 13.97 | ||||||
| Central SBP (V1) | 117.52 | 12.84 | 113.74 | 12.33 | ||||||
| Central SBP (V2-V1) | –4.11 | –7.87 | –0.34 | 0.034 | 1.38 | –3.66 | 6.41 | 0.582 | ||
| Central DBP (V2) | 81.15 | 10.79 | 80.38 | 10.37 | ||||||
| Central DBP (V1) | 81.82 | 10.19 | 81.53 | 9.47 | ||||||
| Central DBP (V2-V1) | –0.67 | –3.17 | 1.82 | 0.588 | –1.14 | –4.72 | 2.43 | 0.520 | ||
| HBPM SBP (V2) | 121.69 | 10.27 | 122.31 | 12.87 | ||||||
| HBPM SBP (V1) | 123.13 | 10.34 | 121.92 | 12.51 | ||||||
| HBPM SBP (V2-V1) | –1.44 | –4.02 | 1.15 | 0.268 | 0.39 | –1.93 | 2.70 | 0.735 | ||
| HBPM DBP (V2) | 80.56 | 10.16 | 79.81 | 6.38 | ||||||
| HBPM DBP (V1) | 80.87 | 9.25 | 79.39 | 7.94 | ||||||
| HBPM DBP (V2-V1) | –0.31 | –1.86 | 1.25 | 0.691 | 0.42 | –1.37 | 2.20 | 0.638 | ||
| PVW (V2) | 7.77 | 1.24 | 8.42 | 1.61 | ||||||
| PWV (V1) | 7.82 | 1.37 | 8.28 | 1.69 | ||||||
| PVW (V2-V1) | –0.05 | –0.22 | 0.13 | 0.584 | 0.14 | –0.07 | 0.35 | 0.179 | ||
| FMD (V2) | 14.28 | 6.67 | 7.23 | 5.71 | ||||||
| FMD (V1) | 10.16 | 5.24 | 10.57 | 6.31 | ||||||
| FMD (V2-V1) | 4.12 | 1.41 | 6.82 | 0.004 | –3.34 | –6.36 | –0.33 | 0.031 | ||
[i] SD – standard deviation, V1 – initial visit, V2 – final visit, SBP - systolic blood pressure, DBP - diastolic blood pressure, HBPM – home blood pressure measurement, PWV – pulse wave velocity, FMD – flow mediated dilation.
Table 4
Study outcomes: between groups comparison.
| OUTCOME | GROUP | n | MEAN | SD | 95% CI | p-VALUE1 | MEAN | 95% CI | p-VALUE2 |
|---|---|---|---|---|---|---|---|---|---|
| Office SBP (V2 – V1) | Control | 36 | –0.56 | 17.26 | (–6.4; 5.29) | 0.047 | –0.38 | (–5.56; 4.81) | 0.063 |
| Intervention | 39 | –7.60 | 12.71 | (–11.7; –3.48) | –7.37 | (–12.96; –1.79) | |||
| Office DBP (V2 – V1) | Control | 36 | 4.38 | 7.51 | (1.83; 6.91) | 0.102 | 4.49 | (1.72; 7.27) | 0.031 |
| Intervention | 39 | 1.19 | 8.98 | (–1.72; 4.1) | 0.14 | (–2.85; 3.13) | |||
| Central SBP (V2 – V1) | Control | 36 | 1.38 | 14.88 | (–3.65; 6.41) | 0.078 | 1.77 | (–2.71; 6.25) | 0.038 |
| Intervention | 39 | –4.10 | 11.62 | (–7.87; –0.34) | –5.00 | (–9.82; –0.17) | |||
| Central DBP (V2 – V1) | Control | 36 | –1.15 | 10.56 | (–4.7; 2.43) | 0.824 | –1.06 | (–4.13; 2.00) | 0.684 |
| Intervention | 39 | –0.68 | 7.71 | (–3.17; 1.82) | –1.96 | (–5.26; 1.34) | |||
| HBPM SBP (V2 – V1) | Control | 36 | 0.39 | 6.84 | (–1.93; 2.70) | 0.293 | 0.68 | (–1.84; 3.20) | 0.579 |
| Intervention | 39 | –1.44 | 7.98 | (–4.02; 1.15) | –0.32 | (–3.04; 2.39) | |||
| HBPM DBP (V2 – V1) | Control | 36 | 0.42 | 5.27 | (–1.37; 2.2) | 0.535 | 0.52 | (–1.20; 2.25) | 0.722 |
| Intervention | 39 | –0.31 | 4.80 | (–1.86; 1.25) | 0.09 | (–1.77; 1.94) | |||
| PWV (V2 – V1) | Control | 36 | 0.15 | 0.62 | (–0.06; 0.36) | 0.155 | 0.17 | (–0.03; 0.37) | 0.134 |
| Intervention | 39 | –0.05 | 0.55 | (–0.22; 0.13) | –0.04 | (–0.25; 0.17) | |||
| FMD (V2 – V1) | Control | 36 | –3.34 | 8.90 | (–6.36; –0.33) | <0.001 | –3.01 | (–5.95; –0.07) | <0.001 |
| Intervention | 39 | 4.12 | 8.35 | (1.41; 6.82) | 4.94 | (1.77; 8.11) |
[i] 1p-value from unpaired two-samples t-test with equal variance; 2p-value from ANCOVA models adjusted for gender and BMI (baseline).
SD – standard deviation, V1 – initial visit, V2 – final visit, SBP - systolic blood pressure, DBP - diastolic blood pressure, HBPM – home blood pressure measurement, PWV – pulse wave velocity, FMD – flow mediated dilation.
Table 5
Study outcomes: within group comparisons between first and final visits (missing imputation analyses).
| OUTCOME | SPIRITUALITY-BASED INTERVENTION GROUP (G1) n = 51 | CONTROL GROUP (G2) n = 49 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MEAN | SD | LOWER 95%CI | UPPER 95%CI | P-VALUE | MEAN | SD | LOWER 95%CI | UPPER 95%CI | P-VALUE | |
| Office SBP (V2) | 121.95 | 11.67 | 125.05 | 13.80 | ||||||
| Office SBP (V1) | 130.14 | 15.29 | 127.93 | 15.15 | ||||||
| Office SBP (V2-V1) | –8.19 | –11.85 | –4.52 | < 0.001 | –2.88 | –7.83 | 2.07 | 0.248 | ||
| Office DBP (V2) | 81.09 | 10.02 | 82.67 | 8.40 | ||||||
| Office DBP (V1) | 79.57 | 10.92 | 77.95 | 8.84 | ||||||
| Office DBP (V2-V1) | 1.52 | –1.01 | 4.06 | 0.234 | 4.72 | 2.74 | 6.70 | <0.001 | ||
| Central SBP (V2) | 114.11 | 10.56 | 114.80 | 12.15 | ||||||
| Central SBP (V1) | 117.54 | 12.91 | 114.40 | 12.59 | ||||||
| Central SBP (V2-V1) | –3.43 | –6.88 | 0.01 | 0.051 | 0.40 | –3.71 | 4.52 | 0.845 | ||
| Central DBP (V2) | 80.86 | 9.49 | 80.46 | 9.02 | ||||||
| Central DBP (V1) | 81.80 | 10.60 | 81.91 | 9.50 | ||||||
| Central DBP (V2-V1) | –0.95 | –3.32 | 1.42 | 0.426 | –1.44 | –4.35 | 1.46 | 0.324 | ||
| HBPM SBP (V2) | 121.79 | 10.63 | 123.24 | 12.44 | ||||||
| HBPM SBP (V1) | 122.60 | 10.73 | 123.28 | 12.46 | ||||||
| HBPM SBP (V2-V1) | –0.8 | –2.94 | 1.34 | 0.455 | –0.04 | –1.96 | 1.88 | 0.965 | ||
| HBPM DBP (V2) | 80.51 | 9.44 | 79.90 | 5.77 | ||||||
| HBPM DBP (V1) | 80.54 | 9.50 | 80.15 | 7.28 | ||||||
| HBPM DBP (V2-V1) | –0.03 | –1.42 | 1.37 | 0.968 | –0.25 | –1.70 | 1.21 | 0.735 | ||
| PVW (V2) | 7.95 | 1.33 | 8.45 | 1.60 | ||||||
| PWV (V1) | 7.97 | 1.47 | 8.30 | 1.72 | ||||||
| PVW (V2-V1) | –0.02 | –0.17 | 0.13 | 0.769 | 0.15 | –0.03 | 0.32 | 0.103 | ||
| FMD (V2) | 14.08 | 6.22 | 7.10 | 5.01 | ||||||
| FMD (V1) | 9.83 | 5.13 | 10.15 | 6.12 | ||||||
| FMD (V2-V1) | 4.25 | 1.95 | 6.56 | <0.001 | –3.05 | –5.46 | –0.65 | 0.014 | ||
[i] SD – standard deviation, V1 – initial visit, V2 – final visit, SBP - systolic blood pressure, DBP - diastolic blood pressure, HBPM – home blood pressure measurement, PWV – pulse wave velocity, FMD – flow mediated dilation.
Table 6
Study outcomes: between groups comparison (missing imputation analyses).
| OUTCOME | GROUP | N | MEAN | SD | 95% CI | p-VALUE1 | MEAN | 95% CI | p-VALUE2 |
|---|---|---|---|---|---|---|---|---|---|
| Office SBP (V2 – V1) | Control | 49 | –2.88 | 17.24 | (–7.83; 2.07) | 0.085 | –2.457 | (–6.858; 1.944) | 0.045 |
| Intervention | 51 | –8.19 | 13.03 | (–11.8; –4.52) | –8.959 | (–13.775; –4.143) | |||
| Office DBP (V2 – V1) | Control | 49 | 4.72 | 6.91 | (2.735; 6.70) | 0.050 | 4.869 | (2.549; 7.19) | 0.019 |
| Intervention | 51 | 1.52 | 9.03 | (–1.01; 4.06) | 0.828 | (–1.712; 3.367) | |||
| Central SBP (V2 – V1) | Control | 49 | 0.40 | 14.33 | (–3.71; 4.52) | 0.153 | 1.09 | (–2.645; 4.826) | 0.042 |
| Intervention | 51 | –3.43 | 12.25 | (–6.88; 0.01) | –4.519 | (–8.607; –0.43) | |||
| Central DBP (V2 – V1) | Control | 49 | –1.44 | 10.11 | (–4.35; 1.46) | 0.791 | –1.114 | (–3.758; 1.53) | 0.736 |
| Intervention | 51 | –0.95 | 8.43 | (–3.32; 1.42) | –1.766 | (–4.66; 1.128) | |||
| HBPM SBP (V2 – V1) | Control | 49 | –0.04 | 6.69 | (–1.96; 1.88) | 0.598 | 0.273 | (–1.794; 2.339) | 0.847 |
| Intervention | 51 | –0.80 | 7.60 | (–2.94; 1.34) | –0.019 | (–2.28; 2.243) | |||
| HBPM DBP (V2 – V1) | Control | 49 | –0.25 | 5.07 | (–1.7; 1.21) | 0.828 | –0.035 | (–1.483; 1.413) | 0.634 |
| Intervention | 51 | –0.03 | 4.96 | (–1.42; 1.37) | 0.469 | (–1.116; 2.054) | |||
| PWV (V2 – V1) | Control | 49 | 0.15 | 0.61 | (–0.03; 0.32) | 0.146 | 0.162 | (–0.002; 0.327) | 0.08 |
| Intervention | 51 | –0.02 | 0.53 | (–0.17; 0.13) | –0.05 | (–0.229; 0.13) | |||
| FMD (V2 – V1) | Control | 49 | –3.05 | 8.37 | (–5.46; –0.65) | <0.001 | –2.738 | (–5.137; –0.338) | <0.001 |
| Intervention | 51 | 4.25 | 8.18 | (1.95; 6.55) | 4.587 | (1.961; 7.214) |
[i] 1p-value from unpaired two-samples t-test with equal variance; 2p-value from Ancova models adjusted for gender and BMI (baseline).
SD – standard deviation, V1 – initial visit, V2 – final visit, SBP - systolic blood pressure, DBP - diastolic blood pressure, HBPM – home blood pressure measurement, PWV – pulse wave velocity, FMD – flow mediated dilation.