Table 2: Subject’s mean FBG, 95% CI and difference of mean (p-value) at baseline and after intervention
Study Group at Baseline
FBG (mg/dL) < 126 126-140 141-160 161-180 181-200 ≥ 201 Mean SD p-value
Control 0 0 1 6 10 20 204.28 33.60 0.133
Intervention 0 0 0 11 6 20 224 72.6
Study Group at 12 Weeks
FBG (mg/dL) < 126 126-140 141-160 161-180 181-200 ≥ 201 Mean SD p-value
Control 0 0 0 2 5 30 242.27 35.27 0.000
Intervention 28 4 3 0 2 0 108.54 32.858
The mean FBG for the control group at baseline was 204 ± 33.60 mg/dL while that of the intervention group was 224 ± 72.6 mg/dL. At the end of the study, the mean FBG for the control group was 242.27 ± 35.27 mg/dL and for the intervention group 108.54 ± 32.858 mg/dL, reflecting improvement in glycaemic control in the intervention group (p<0.05).
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Table 3: Subjects’ HbA1c at baseline and after intervention, mean HbA1c, 95% CI and difference of mean (p –value)
Study Groups at Baseline
HbA1c (%) < 7 7-8 9-10 ≥ 11 Mean SD p-value
Control 4 9 16 8 9.35 2.11 0.858
Intervention 2 11 13 11 9.27 1.76
Study Groups at 12 weeks
HbA1c (%) <7 7-8 9-10 ≥ 11 Mean SD p-value
Control 0 2 12 23 10.95 1.56 0.000
Intervention 22 9 6 0 6.46 1.66
The mean HbA1c for the control group at baseline was 9.35±2.11% while that of the intervention group was 9.27±1.76% at baseline. After intervention, the mean HbA1c for the control group was 10.95±1.56% and that of the intervention group was 6.46±1.66 %( p=0.00), indicating improvement in glycaemic control in the intervention group.
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Table 4: Number of subjects according to each variable which is indicated by the rating scale (0, 1, 2, 3, ≥ 4 times/day or times/week); Mean of rating scale and difference of mean (p-value) at baseline and after intervention.
Study Group at Baseline
Variables 0 1 2 3 ≥ 4 Mean SD p-value
Number of meals (times/day)
Control 0 0 27 6 4 2.38 0.68 0.190
Intervention 0 1 17 15 4 2.59 0.73
Number of soft drinks (times/day)
Control 10 21 5 1 0 0.92 0.72 1.000
Intervention 10 22 3 2 0 0.92 0.76
Amount of fruits (times/day)
Control 18 18 0 1 0 0.57 0.65 0.737
Intervention 23 9 5 0 0 0.51 0.73
Exercise (times/week)
Control 29 4 2 2 0 0.30 0.70 0.316
Intervention 30 0 2 5 0 0.51 1.10
Study Group at 12 weeks
Variables 0 1 2 3 ≥ 4 Mean SD p-value
Number of meals (times/day)
Control 0 0 26 6 5 2.43 0.73 0.000
Intervention 0 0 0 30 7 3.19 0.40
Number of soft drinks (times/day)
Control 20 14 3 0 0 0.54 0.65 0.000
Intervention 37 0 0 0 0 0.00 0.00
Amount of fruits (times/day)
Control 6 24 5 2 0 1.08 0.72 0.000
Intervention 0 0 1 31 5 3.11 0.39
Exercise (times/week)
Control 18 4 2 3 10 1.54 1.76 0.000
Intervention 0 0 0 0 37 4.00 0.00
Patients’ behaviours in the control group did not change significantly at the end of the study. The average number of meals per day increased from 2.38±0.68 to 2.43±0.73. The number of soft drinks intake reduced from 0.92±0.72 to 0.54±0.64 times per day. The amount of fruits taken
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Increased from 0.57±0.65 to 1.08±0.72 times per day; the number of exercise increased from 0.30±0.70 to 1.54±1.74 times per week (p<0.05). Patients’ behaviours in the intervention group changed significantly (p0.00) as shown in table 4. The average number of meals per day increased from 2.59±0.73 to 3.19±0.40. The number of soft drinks intake also decreased from 0.92±0.76 to 0 times per day. The amount of fruits taken increased from 0.51±0.73 to 3.11±0.39 times per day;
exercise improved from 0.51±1.10 to 4 times per week (p= 0.00).
Table 5: Number of subjects corresponding to diabetes symptoms indicated by presence of symptoms.
Symptoms Intervention Group (N = 37) Control Group (N = 37) Number of present symptoms (%)
BASELINE 12WEEKS BASELINE 12 WEEKS
Polydipsia 37(100%) 0 37 (100%) 26 (70.3%)
Polyuria 37 (100%) 0 37 (100%) 26 (70.3%)
Numbness 6 (16.2) 1 (2.7%) 37 (100%) 26 (70.3%)
Weakness 37 (100%) 0 37 (100%) 23 (62.2%)
Polyphagia 35 (94.6%) 0 24 (64.9%) 21 (56.8%)
Blurred vision 22 (59.5%) 2 (5.4%) 2 (5.4%) 2 (5.4)
Nocturia 30 (81.1%) 0 23 (62.2%) 23 (62.2%)
In the intervention group, symptoms such as polydipsia, polyuria, numbness, weakness, polyphagia, blurred vision and nocturia improved compared to the control group.
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Table 6: Comparison of the mean weights, BMIs and blood pressures of subjects group before and after intervention.
Body Mass Index (BMI) and Blood pressure (BP) at Baseline
Study Groups at Baseline
Characteristics intervention Control P-value
Weight (kg) 75+16.3 68.7+13.3 0.000
Height (m) 1.63+0.07 1.61+0.08 0.499
BMI (kg/m2) 28+6.2 26.24+4.9 0.000
Blood Pressure (mmHg)
Systolic 125+12 127+18 0.648
Diastolic 80+6 77+8.5 0.648
Study Groups at 12 weeks
Characteristics intervention Control P-value
Weight (kg) 72.4+15.8 69.1+13.2 0.000
Height (m) 1.63+0.07 1.61+0.08 0.499
BMI (kg/m2) 27.3+6.1 26.4+4.9 0.000
Blood Pressure (mmHg)
Systolic 127+11 137+17 0.648
Diastolic 80+6 74+65 0.626
The mean weights of patients in both control and intervention groups were high at baseline. At the end of the study, the mean weight of individuals in the control group increased 0.4±13.2kg,
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whereas the mean weight of subjects in the intervention group decreased 2.6 ±15.8kg. The mean BMIs for both groups at baseline were high. Over the twelve-week study period, the mean BMI decreased 0.7±6.1kg/m2 in the intervention group and increased 0.2±4.9kg/m2 in the control group.
The average systolic and diastolic blood pressures of the subjects in the intervention and control groups were normal at baseline. At the study end point, the mean systolic and diastolic blood pressure of subjects in the intervention group was normal whereas, in the control group, the mean systolic blood pressure was high but the mean diastolic pressure was normal.
4. Quality of life of patients
Table 7: Overall quality of life of subjects before and after intervention Overall quality of life
Patient Group At Baseline P-value At 12 weeks P-value
Good Fair Poor Good Fair Poor
Control 13 12 12 0.746 0 13 14 0.000
(35.1) (32.4) (32.4) (35.1) (37.8)
Intervention 10 14 13 36 1 0
(27.0) (37.8) (35.1) (97.3) (2.7)
At baseline; among the control group: 13 (35.1%) had a good score, 12 (32.4%) had a fair score and 12(32.4%) had a poor score for overall quality of life; while among the intervention group, 10(27%) had a good score, 14(37.8%) had a fair score and 13(35.1%) had a poor score for overall QOL. After intervention; among the control group, none had a good score, 13(35.1%) had a fair score and 14(37.8%) had a poor score in overall quality of life whereas among the intervention group: 36(97.3%) had a good score, 1(2.7%) had a fair score and none had a poor score.
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Table 8: Quality of life of patients in individual domains before and after intervention Patients’ Quality of Life in Individual Domains at Baseline
VARIABLE
Physical Domain 1
Psychological Domain 2
Social Domain 3
Environment Domain 4 Good Fair Poor Good Fair Poor Good Fair Poor Good Fair Poor
Control 0 24
(64.9) 13 (35.1)
0 25
(67.6) 12 (32.4)
0 0
24 (64.9)
13 (35.1)
12 (32.4)
12 (32.4)
13 (35.1) Intervention 0 22 15
(59.5) (40.5)
0 11 26
(29.7) (70.3) 4 (10.8)
20 (54.1)
17 (45.9)
11 (29.7)
13 (35.1)
13 (35.1)
Patients’ Quality of Life in Individual Domains at 12 weeks VARIABLE
Physical Domain 1
Psychological Domain 2
Social Domain 3
Environment Domain 4 Good Fair Poor Good Fair Poor Good Fair Poor Good Fair Poor Control 0
9 (24.3)
28 (75.7)
0
17 (45.9)
20 (54.1)
0 10
(27)
27 (73.0)
7 (18.9)
15 (40.5)
15 (40.5) Intervention 30 7 0
( 81.1) (18.9)
30 7 0 (81.1) (18.9)
32 (86.5)
5 (13.5)
0 16
(43.2) 16 (43.2)
5 (13.5) For physical health (domain 1) domain, at baseline: among the control group, no patient had a
good score, 24(64.9%) had a fair score, and 13(35.1%) had a poor score. Among the intervention group, none had a good score, 22(59.55) had a fair score and 15(40.5%) had a poor score. At study
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end point: among the control group, no patient had a good score, 9(24.9) had a fair score and 28(75.7) had a poor score whereas among the intervention group, 30(81.1) had a good score, 7(18.9) had a fair score and none had a poor score.
In the psychological domain (domain 2), at baseline: among the control group, none had a good score, 25(67.6%) had a fair score and 12(32.4%) had a poor score. While among the intervention group, none had a good score, 11(29.7%) had a fair score and 26(70.3%) had a poor score. At study end point: among the control group, none had a good score, 17(45.9) had fair score and
20(54.1) had a poor score whereas among the intervention group, 30(81.1) had a good score, 7(18.9) had a fair score and none had a poor score.
For social relationships (domain 3), at baseline: among the control group none had a good score, 24(64.95) had a fair score and 13(35.1%) had a poor score. Among the intervention group, 4(10.8%) had a good score, 20(54.1%) had a fair score and 17(45.9%) had a poor score. At the end of the study: among the control group, none had a good score, 10(27%) had a fair score and 27(73) had a poor score whereas among the intervention group, 32(86.5%) had a good score, 5(13.5%) had a fair score, and none had a poor score.
For the environmental domain (domain 4), at baseline: among the control group, 12(32.4%) had a good score, 12(32.4%) had a fair score, 13(35.1%) had poor score. Among the intervention group, 11(29.7%) had a good score, 13(35.1%) had a fair score and 13(35.1%) had a poor score. At study end point: among the control group, 7(18.9) had a good score, 15(40.5%) had a fair score, and 15(40.5%) had a poor score. While among the intervention group, 16(43.2%) had a good score, 16(43.2%) had a fair score, and 5 (13.5%) had a poor score.
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CHAPTER FIVE DISCUSSION
5.1 DEMOGRAPHIC CHARACTERISTICS OF PATIENTS AT BASELINE