Introduction
Methods
Study Design and Participants
Randomization
Procedures
Objectives
Statistical Analysis
Results
Patient Demographic and Biomedical Characteristics at Baseline
All patients (N = 457) | Control group (n = 227) | Empowerment group (n = 230) | p value | |
---|---|---|---|---|
Demographic data | ||||
Age (SD) | 62.7 (11.4) | 63.8 (10.1) | 61.5 (6.7) | 0.047 |
Female (%) | 43.5 | 42.3 | 44.8 | 0.591 |
BMI (kg/m2) | 30.6 (5.3) | 30.3 (5.0) | 30.8 (5.6) | 0.203 |
Diabetes duration (SD) | 8.5 (6.5) | 8.8 (6.3) | 8.3 (6.7) | 0.152 |
Diabetes history in 1st degree relatives (%) | 53.8 | 54.2 | 53.5 | 0.952 |
Biomedical characteristics | ||||
Comorbidities, all (%) | 75.7 | 78.9 | 72.6 | 0.120 |
Diabetes complications, all (%) | 7.7 | 8.4 | 7.0 | 0.570 |
Physical training | ||||
Intense activity for ≥ 20 min, once or more times per week | 109 (24.0) | 52 (23.0) | 57 (24.9) | 0.638 |
No or limited weekly activity | 346 (76.0) | 174 (77.0) | 172 (75.1) | |
Patients on specific diabetes diet (%) | 47.5 | 53.7 | 41.3 | 0.028 |
Smoking | 0.340 | |||
Current | 14.4 | 11.9 | 17.0 | |
Former | 21.0 | 22.5 | 19.6 | |
Never | 61.7 | 63.4 | 60.0 | |
Alcohol consumption | 0.004 | |||
Daily | 4.2 | 4.0 | 4.3 | |
Never | 56.9 | 65.2 | 48.7 | |
Occasionally | 36.8 | 29.1 | 44.3 | |
Diabetes treatments (%) | ||||
Biguanides | 65.9 | 64.8 | 67.0 | |
DPP-4 | 46.0 | 43.2 | 48.7 | |
SGLT-2 | 22.8 | 23.8 | 21.7 | |
Insulin (all types) | 1.8 | 0.9 | 2.6 | |
HbA1c | 7.8 (0.9) | 7.7 (0.8) | 8.0 (1.0) | 0.001 |
FPG (mg/dl) | 149.1 (40.5) | 140.9 (31.0) | 157.0 (46.6) | 0.001 |
PPG (mg/dl) | 175.1 (50.6) | 162.1 (30.9) | 188.3 (62.2) | 0.001 |
Triglycerides (mg/dl) | 162.9 (81.3) | 156 (68.3) | 169.8 (92.2) | 0.446 |
HDL-C (mg/dl) | 45.7 (11.3) | 46.4 (10.9) | 45.0 (11.7) | 0.261 |
LDL-C (mg/dl) | 103.6 (31.6) | 100.5 (29.7) | 106.6 (33.1) | 0.108 |
TC (mg/dl) | 183.3 (36.2) | 180.8 (33.6) | 185.8 (38.6) | 0.159 |
DBP (mmHg) | 79.1 (8.2) | 79.5 (8.4) | 78.8 (8.0) | 0.766 |
SBP (mmHg) | 131.4 (12.9) | 132.0 (13.3) | 130.9 (12.5) | 0.521 |
Patient-reported outcomes | ||||
MMAS-4 score | 3.2 (1.1) | 3.2 (1.1) | 3.2 (1.0) | 0.849 |
EQ-5D-5L score | 0.81 (0.19) | 0.82 (0.18) | 0.80 (0.20) | 0.376 |
EQ-VAS score | 75.8 (16.7) | 78.8 (16.1) | 72.9 (16.8) | 0.000 |
DTSQs score | 27.1 (6.4) | 29.1 (6.7) | 25.0 (6.7) | 0.000 |
Patient Support During Follow-Up Period
Improvement in Self-Reported Adherence Rates During Follow-Up
Control group (n = 227) | Empowerment group (n = 230) | p value | |
---|---|---|---|
Baseline | |||
High adherence | 130 (57.3) | 124 (53.9) | 0.470 |
Medium/low adherence | 97 (42.7) | 106 (46.1) | |
4 months | |||
High adherence | 135 (61.1) | 157 (70.7) | 0.032 |
Medium/low adherence | 86 (38.9) | 65 (29.3) | |
8 months | |||
High adherence | 144 (65.8) | 157 (72.7) | 0.117 |
Medium/low adherence | 75 (34.2) | 59 (27.3) |
Improvement in Biomedical Characteristics During Follow-Up
Patient group | p value | ||
---|---|---|---|
Control group (n = 227) | Empowerment group (n = 230) | ||
HbA1c (%) | |||
Baseline | 7.7 (0.8) | 8.0 (1.0) | 0.001 |
4 months | 7.0 (0.6) | 7.1 (0.6) | 0.724 |
8 months | 6.9 (0.6) | 7.0 (0.6) | 0.114 |
FPG (mg/dl) | |||
Baseline | 140.9 (31.0) | 157.0 (46.6) | 0.001 |
4 months | 125.7 (21.6) | 128.1 (23.5) | 0.318 |
8 months | 120.6 (21.6) | 123.1 (21.9) | 0.294 |
PPG (mg/dl) | |||
Baseline | 162.1 (30.9) | 188.3 (62.2) | 0.001 |
4 months | 141.1 (20.4) | 154.8 (28.8) | 0.001 |
8 months | 141.4 (24.5) | 149.2 (24.5) | 0.016 |
TC (mg/dl) | |||
Baseline | 180.8 (33.6) | 185.8 (38.6) | 0.159 |
4 months | 177.3 (26.3) | 178.3 (32.7) | 0.769 |
8 months | 172.8 (25.7) | 179.7 (32.1) | 0.088 |
TG (mg/dl) | |||
Baseline | 156.0 (68.3) | 169.8 (92.2) | 0.446 |
4 months | 140.2 (45.8) | 148.4 (61.4) | 0.362 |
8 months | 137.1 (47.6) | 144.4 (60.6) | 0.271 |
HDL-C (mg/dl) | |||
Baseline | 46.4 (10.9) | 45.0 (11.7) | 0.261 |
4 months | 47.7 (10.2) | 47.2 (11.7) | 0.643 |
8 months | 47.6 (9.8) | 47.2 (10.8) | 0.726 |
LDL-C (mg/dl) | |||
Baseline | 100.5 (29.7) | 106.6 (33.1) | 0.108 |
4 months | 100.0 (25.1) | 97.9 (28.5) | 0.365 |
8 months | 94.8 (26.3) | 101.1 (30.1) | 0.183 |
DBP (mmHg) | |||
Baseline | 79.5 (8.4) | 78.8 (8.0) | 0.766 |
4 months | 78.9 (7.7) | 78.2 (7.2) | 0.301 |
8 months | 78.3 (7.2) | 78.5 (7.9) | 0.740 |
SBP (mmHg) | |||
Baseline | 132.0 (13.3) | 130.9 (12.5) | 0.521 |
4 months | 129.6 (12.1) | 128.3 (10.7) | 0.708 |
8 months | 129.7 (12.4) | 129.0 (10.7) | 0.778 |
Intense physical activity, n (%) | |||
Baseline | 52 (23.0) | 57 (24.9) | 0.638 |
4 months | 56 (25.2) | 86 (38.7) | 0.002 |
8 months | 59 (26.9) | 103 (47.2) | < 0.001 |