1. Background
2. Objectives
3. Methods
3.1. Design
3.2. Participants
3.3. Study Setting and Procedure
3.4. Intervention
3.5. Measurements
3.6. Sample Size
3.7. Randomization Type
3.8. Allocation Concealment
3.9. Statistical Analysis
3.10. Ethics
4. Results
| Macro and Micronutrient Characteristics of Participants | Intervention Group (n = 44) | Control Group (n = 44) | P-Value |
|---|---|---|---|
| Calories (kcal/d) | |||
| Baseline | 2628.55 ± 437.36 | 2806.33 ± 874.62 | 0.3 |
| End of trial | 2387.34 ± 409.61 | 2618.96 ± 362.45 | 0.006 |
| P | 0.0001 | 0.5 | |
| Protein (g/d) | |||
| Baseline | 83.29 ± 16.04 | 77.80 ± 14.64 | 0.06 |
| End of trial | 88.14 ± 14.71 | 79.75 ± 15.67 | 0.01 |
| P | 0.05 | 0.0001 | |
| Fiber (g/1000 kcal) | |||
| Baseline | 12.40 ± 4.47 | 16.61 ± 3.35 | 0.0001 |
| End of trial | 14.93 ± 4.97 | 16.21 ± 0.51 | 0.07 |
| P | 0.001 | 0.3 | |
| Fat (g/d) | |||
| Baseline | 66.46 ± 20.40 | 66.99 ± 21.39 | 0.9 |
| End of trial | 56.87 ± 20.56 | 61.99 ± 17.3 | 0.03 |
| P | 0.0001 | 0.0009 | |
| Carbohydrate (g/d) | |||
| Baseline | 215.57 ± 36.61 | 201.43 ± 42.13 | 0.09 |
| End of trial | 192.25 ± 40.12 | 192.51 ± 40.30 | 0.9 |
| P | 0.0001 | 0.03 | |
| MUFA (g/d) | |||
| Baseline | 29.34 ± 8.64 | 31.29 ± 10.56 | 0.2 |
| End of trial | 24.27 ± 9.40 | 28.37 ± 8.33 | 0.4 |
| P | 0.0001 | 0.02 | |
| PUFA (g/d) | |||
| Baseline | 13.09 ± 3.64 | 14.73 ± 4.26 | 0.03 |
| End of trial | 12.09 ± 3.86 | 15.16 ± 4.09 | 0.001 |
| P | 0.1 | 0.5 | |
| Cholesterol (mg/d) | |||
| Baseline | 480.45 ± 146.85 | 442.99 ± 153.52 | 0.9 |
| End of trial | 389.09 ± 140.72 | 454.15 ± 136.68 | 0.8 |
| P | 0.0001 | 0.1 | |
| Saturated fat (g/d) | |||
| Baseline | 13.44 ± 2.31 | 15.43 ± 2.33 | 0.0001 |
| End of trial | 13.28 ± 2.32 | 15.25 ± 3.10 | 0.001 |
| P | 0.5 | 0.2 | |
| Potassium (mg/d) | |||
| Baseline | 996.69 ± 238.001 | 819.43 ± 358.51 | 0.0001 |
| End of trial | 1285.31 ± 396.98 | 781.03 ± 394.01 | 0.0001 |
| P | 0.0001 | 0.08 | |
| Zn (mg/d) | |||
| Baseline | 7.93 ± 0.54 | 7.88 ± 0.54 | 0.5 |
| End of trial | 7.83 ± 0.56 | 7.90 ± 0.57 | 0.4 |
| P | 0.3 | 0.9 | |
| Calcium (mg/d) | |||
| Baseline | 193.34 ± 88.13 | 186.92 ± 74.61 | 0.8 |
| End of trial | 209.51 ± 90.31 | 186.87 ± 74.95 | 0.2 |
| P | 0.0001 | 0.4 | |
| Magnesium (mg/d) | |||
| Baseline | 148.07 ± 62.53 | 143.60 ± 61.12 | 0.7 |
| End of trial | 174.25 ± 73.17 | 130.85 ± 55.71 | 0.003 |
| P | 0.0001 | 0.02 | |
| Selenium (µg/d) | |||
| Baseline | 0.3817 ± 0.13 | 0.3910 ± 0.13 | 0.7 |
| End of trial | 0.39 ± 0.14 | 0.40 ± 0.13 | 0.9 |
| P | 0.2 | 0.2 | |
| Vitamin C (mg/d) | |||
| Baseline | 89.80 ± 17.91 | 89.70 ± 17.98 | 0.9 |
| End of trial | 98.55 ± 16.26 | 99.88 ± 14.92 | 0.8 |
| P | 0.003 | 0.001 | |
| Vitamin E (mg/d) | |||
| Baseline | 3.87 ± 0.54 | 4.03 ± 0.50 | 0.1 |
| End of trial | 4.07 ± 0.53 | 4.19 ± 0.42 | 0.3 |
| P | 0.1 | 0.09 | |
| Vitamin A (µg/d) | |||
| Baseline | 825.71 ± 72.05 | 881.68 ± 74.95 | 0.0001 |
| End of trial | 861.93 ± 100.004 | 879.55 ± 98.84 | 0.5 |
| P | 0.03 | 0.9 |
a Values are expressed as mean ± SD.
| Patient Characteristics and Macronutrients | Intervention Group (n = 44) | Control Group (n = 44) | P-Value |
|---|---|---|---|
| Number of patients (female) (%) | 48.9 | 51.1 | 0.6 |
| Age (y) | 49.45 ± 10.1 | 49.42 ± 9.63 | 0.9 |
| Income status (%) | 0.9 | ||
| Good | 69.2 | 30.8 | |
| Moderate | 50.9 | 49.1 | |
| Poor | 33.3 | 66.7 | |
| Education status (%) | 0.3 | ||
| ≤ 12 grade | 62.5% | 37.5% | |
| > 12 grade | 48.8% | 51.2% | |
| Physical activity (met min/week) | 1989.96 ± 1163.83 | 1780.40 ± 1036.93 | 0.2 |
| BMI (kg/m2) | |||
| Baseline | 29.51 ± 2.89 | 28.53 ± 2.57 | 0.1 |
| End of trial | 29.40 ± 2.91 | 28.64 ± 2.62 | 0.2 |
| P | 0.002 | 0.05 | |
| HTN duration, (n) | 0.5 | ||
| Less than 5 year | 30 | 28 | |
| More than 5 year | 14 | 16 |
a Values are expressed as mean ± standard deviation unless otherwise indicated.
| Factors Components | Intervention Group | Control Group | P-Value c |
|---|---|---|---|
| F1 | |||
| Baseline | 12.05 ± 8.33 | 14.2 ± 6.33 | 0.2 |
| End of trial | 21.72 ± 2.9 | 9.26 ± 6.65 | 0.001 |
| P | 0.0001 d | 0.0001 d | |
| M1 e | 21.78 (2.22, 23.33) | 9.21 (7.66, 10.76) | 0.0001 |
| M 2 e | 21.90 (19.94, 23.86) | 9.35 (7.39, 11.31) | 0.0001 |
| F2 | |||
| Baseline | 2.38 ± 1.68 | 2.83 ± 2.4 | 0.4 |
| End of trial | 15.52 ± 4.63 | 5.16 ± 4.37 | 0.00001 |
| P | 0.0001 | 0.0001 | |
| M1 | 8.90 (7.68, 10.12) | 3.99 (2.78, 5.21) | 0.0001 |
| M 2 | 9.0 (7.97, 10.02) | 3.89 (2.86, 4.93) | 0.0001 |
| F3 | |||
| Baseline | 5.75 ± 3.55 | 7.11 ± 2.39 | 0.0001 |
| End of trial | 8.26 ± 2.72 | 3.93 ± 3.05 | 0.0001 |
| P | 0.0001 | 0.004 | |
| M1 | 11.96 (10.5, 13.43) | 7.89 (6.43, 9.36) | 0.001 |
| M 2 | 12.64 (11.32, 13.95) | 7.22 (5.90, 8.53) | 0.00001 |
| F4 | |||
| Baseline | 1.22 ± 1.23 | 1.64 ± 2.03 | 0.0001 |
| End of trial | 0.9 ± 1.45 | 0.81 ± 4.43 | 0.1 |
| P | 0.05 | 0.004 | |
| M1 | 5.99 (5.12, 6.85) | 3.88 (3.02, 4.75) | 0.001 |
| M 2 | 5.79 (4.76, 6.81) | 4.09 (3.06, 5.11) | 0.04 |
| F5 | |||
| Baseline | 0.086 ± 3.08 | 1.23 ± 2.56 | 0.1 |
| End of trial | 0.87 ± 1.58 | 0.41 ± 1.98 | 0.4 |
| P | 0.08 | 0.2 | |
| M1 | 2.89 (2.6, 3.16) | 1.26 (1.0, 1.53) | 0.0001 |
| M | 2.86 (2.55, 3.17) | 1.29 (0.98, 1.60) | 0.0001 |
| BP. systolic (mmHg) | |||
| Baseline | 150.43 ± 10.19 | 155.88 ± 16.81 | 0.06 |
| End of trial | 144.65 ± 10.36 | 161.09 ± 17.46 | 0.0001 |
| P | 0.0001 | 0.0001 | |
| M1 | 144.76 (140.51, 149.007) | 160.98 (156.74, 165.23) | 0.0001 |
| M 2 | 144.28 (137.29, 151.28) | 161.46 (154.46, 168.45) | 0.0001 |
| BP. Diastolic (mmHg) | |||
| Baseline | 94.15 ± 7.69 | 96.13 ± 8.41 | 0.7 |
| End of trial | 88.59 ± 8.34 | 97.61 ± 7.27 | 0.0001 |
| P | 0.0001 | 0.1 | |
| M1 | 88.49 (86.22, 90.75) | 97.71 (95.44, 99.97) | 0.0001 |
| M 2 | 85.89 (82.33, 89.45) | 100.31 (96.75, 103.86) | 0.0001 |
| DASH score | |||
| Baseline | 2.895 ± 0.457 | 2.931 ± 0.534 | 0.563 |
| End of trial | 3.837 ± 0.761 | 3.875 ± 0.699 | 0.851 |
| P | < 0.0001 d | < 0.0001 | |
| M1 e | 3.835 (3.616, 4.054) | 3.881 (3.662, 4.100) | 0.771 |
| M 2 | 3.837 (3.626, 4.049) | 3.667 (3.667, 4.090) | 0.787 |
a M1: Model 1 adjusted by age and BMI; M 2: Adjusted by model1 + baseline (dietary intake of energy and macronutrients + fiber + sodium + physical activity). F1: Negative emotions; F2: Availability and physical discomfort; F3: Availability and positive emotions; F4: Social pressure; F5: Disease control and negative emotions. BP systolic: Systolic blood pressure; BP diastolic: Diastolic blood pressure.
b Values are expressed as mean ± SD or mean (95%CI).
c P values denote the significance of between-group differences (P < 0.05, Mann-Whitney U test for non-normal distribution data) and independent t-test (for normal distribution data).
d P values denote the significance of within-group changes (P < 0.05, paired-t test (for normal distribution data) and Wilcoxon test (for non-normal distribution data).
e P value adjusted obtained from ANCOVA.
