Table 2.
Group Means for Clinical and Self-Report Outcomes at 0, 4, and 10 Months Among the Three Groups
CG | PD | PD-TE | ||||
---|---|---|---|---|---|---|
n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | |
HbA1c (% unit) | ||||||
Baseline | 100 | 10.90 (2.01) | 99 | 11.39 (2.52) | 102 | 11.19 (2.03) |
Month 4 | 84 | 9.66 (2.71) | 77 | 8.27 (2.13) | 85 | 7.68 (2.13) |
Month 10 | 92 | 9.56 (2.79) | 82 | 8.68 (2.76) | 89 | 8.19 (2.17) |
Change 0–4 monthsa | −1.20 (2.89) | −3.11 (2.86) | −3.37 (2.80) | |||
Change 0–10 monthsa | −1.30 (3.29) | −2.63 (3.73) | −3.02 (2.83) | |||
HbA1c (mmol/mol) | ||||||
Baseline | 100 | 96 (22.0) | 99 | 101 (27.5) | 102 | 99 (22.2) |
Month 4 | 84 | 83 (29.6) | 77 | 67 (23.3) | 85 | 61 (23.3) |
Month 10 | 92 | 81 (30.5) | 82 | 72 (30.2) | 89 | 66 (23.7) |
Change 0–4 monthsa | −13.1 (31.6) | −34.0 (31.3) | −36.8 (30.6) | |||
Change 0–10 monthsa | −14.2 (36.0) | −28.7 (40.8) | −33.0 (30.9) | |||
Total cholesterol (mg/dL) | ||||||
Baseline | 89 | 209.92 (38.99) | 94 | 206.46 (39.79) | 100 | 206.02 (37.14) |
Month 4 | 79 | 201.00 (36.73) | 74 | 189.47 (35.98) | 83 | 188.06 (31.71) |
Month 10 | 90 | 205.13 (38.84) | 79 | 195.80 (40.17) | 85 | 191.12 (39.04) |
Change 0–4 months | −10.91 (34.77) | −14.07 (36.89) | −14.08 (35.82) | |||
Change 0–10 months | −6.96 (31.18) | −7.40 (33.19) | −13.75 (36.94) | |||
Triglycerides (mg/dL) | ||||||
Baseline | 87 | 249.09 (141.48) | 92 | 231.46 (169.83) | 99 | 231.20 (148.93) |
Month 4 | 78 | 203.17 (115.00) | 74 | 168.22 (90.96) | 83 | 173.48 (90.67) |
Month 10 | 86 | 210.57 (122.79) | 75 | 173.97 (81.61) | 86 | 180.16 (96.39) |
Change 0–4 months | −49.05 (131.69) | −41.25 (113.65) | −49.74 (125.69) | |||
Change 0–10 months | −25.30 (128.11) | −29.85 (106.45) | −46.76 (120.4) | |||
LDL-c (mg/dL) | ||||||
Baseline | 52 | 118.64 (38.05) | 67 | 114.91 (29.87) | 75 | 109.74 (35.59) |
Month 4 | 68 | 117.83 (31.91) | 63 | 107.71 (24.83) | 78 | 108.20 (27.52) |
Month 10 | 75 | 117.45 (34.92) | 63 | 112.00 (28.41) | 77 | 111.54 (26.10) |
Change 0–4 months | +4.31 (31.59) | −4.11 (28.93) | −1.18 (35.70) | |||
Change 0–10 months | +0.45 (35.22) | −0.40 (24.91) | −0.26 (33.52) | |||
HDL-c (mg/dL) | ||||||
Baseline | 51 | 40.08 (9.50) | 67 | 41.56 (8.42) | 75 | 40.83 (7.96) |
Month 4 | 69 | 41.00 (10.17) | 66 | 43.28 (10.49) | 77 | 43.69 (10.72) |
Month 10 | 77 | 44.75 (12.07) | 64 | 42.72 (10.61) | 77 | 43.38 (11.71) |
Change 0–4 months | +1.67 (9.11) | +2.99 (11.97) | +2.35 (10.24) | |||
Change 0–10 monthsa | +6.05 (13.47) | +1.57 (8.78) | +1.53 (9.30) | |||
BMI (kg/m2) | ||||||
Baseline | 100 | 30.79 (5.10) | 97 | 31.15 (5.41) | 100 | 30.74 (5.29) |
Month 4 | 84 | 31.11 (5.32) | 75 | 31.55 (5.28) | 85 | 31.20 (5.19) |
Month 10 | 91 | 30.79 (4.98) | 74 | 32.08 (5.01) | 88 | 31.23 (5.27) |
Change 0–4 months | +0.07 (1.32) | +0.08 (1.58) | +0.01 (1.69) | |||
Change 0–10 months | −0.08 (1.67) | +0.25 (2.06) | +0.23 (2.27) | |||
SBP (mm Hg) | ||||||
Baseline | 100 | 122.70 (15.65) | 97 | 120.05 (11.71) | 100 | 123.78 (15.35) |
Month 4 | 84 | 121.26 (12.66) | 76 | 119.59 (13.51) | 85 | 120.00 (13.34) |
Month 10 | 90 | 123.02 (12.58) | 77 | 119.69 (14.24) | 87 | 120.13 (14.26) |
Change 0–4 monthsb | −2.43 (15.7) | −0.08 (15.85) | −4.47 (15.15) | |||
Change 0–10 months | −0.64 (16.0) | +0.08 (15.72) | −4.05 (16.86) | |||
DBP (mm Hg) | ||||||
Baseline | 100 | 78.09 (9.73) | 97 | 75.90 (8.18) | 100 | 78.88 (8.54) |
Month 4 | 84 | 75.98 (8.02) | 76 | 74.12 (8.11) | 85 | 74.78 (11.71) |
Month 10 | 91 | 76.85 (6.82) | 77 | 75.60 (9.13) | 87 | 75.22 (8.55) |
Change 0–4 months | −2.34 (10.85) | −0.68 (10.01) | −4.28 (13.13) | |||
Change 0–10 months | −1.82 (10.77) | +0.14 (11.48) | −3.74 (10.32) | |||
Self-efficacy | ||||||
Baseline | 97 | 46.81 (16.37) | 88 | 48.82 (18.10) | 92 | 54.75 (16.02) |
Month 10 | 81 | 57.37 (17.04) | 62 | 61.77 (18.93) | 77 | 63.29 (17.26) |
Change 0–10 months | +9.66 (22.02) | +12.08 (21.63) | +9.12 (19.29) | |||
Depression | ||||||
Baseline | 97 | 6.52 (4.99) | 89 | 7.48 (5.29) | 93 | 7.73 (5.77) |
Month 10 | 81 | 5.56 (4.79) | 62 | 4.81 (4.26) | 77 | 5.13 (4.48) |
Change 0–10 months | −0.83 (5.44) | −2.35 (4.83) | −2.36 (5.07) | |||
Lifestyle | ||||||
Baseline | 95 | 58.26 (12.52) | 89 | 61.79 (13.36) | 93 | 62.57 (13.13) |
Month 10 | 81 | 69.68 (11.93) | 62 | 77.60 (9.20) | 77 | 76.90 (11.80) |
Change 0–10 months | +11.78 (13.99) | +14.08 (11.00) | +14.44 (13.95) | |||
Quality of lifec | ||||||
Baseline | 97 | 31.11 (17.60) | 88 | 31.40 (20.99) | 93 | 30.09 (18.10) |
Month 10 | 81 | 24.51 (18.12) | 62 | 16.68 (14.81) | 77 | 19.28 (16.88) |
Change 0–10 months | −6.53 (20.57) | −15.41 (21.66) | −11.40 (18.65) | |||
Diabetes knowledge | ||||||
Baseline | 51 | 13.69 (4.22) | 49 | 14.12 (3.45) | 48 | 14.21 (3.91) |
Month 10 | 81 | 14.83 (3.16) | 62 | 16.76 (2.98) | 77 | 17.30 (3.56) |
Change 0–10 months | +1.15 (4.05) | +3.20 (3.28) | +3.24 (4.15) |
The following Spanish-validated survey instruments were used to measure self-efficacy, depression, lifestyle, quality of life, and diabetes knowledge, respectively: the Spanish Diabetes Self-Efficacy,32 the Patient Health Questionnaire,33 the Instrument to Measure Lifestyle of Type 2 Diabetes Mellitus Patients,34 Diabetes 39,35 and the Diabetes Knowledge Questionnaire 24.36 Unadjusted means are presented for 0, 4, and 10 months for descriptive purposes. Results for within-group changes were examined using analyses of covariance and controlling for age and sex. Sample sizes vary for each analysis because of missing values.
Levels of significance are indicated: aP < 0.01, bP < 0.05.
Higher scores mean quality of life is adversely affected. Thus reductions in quality of life scores represent positive gains in quality of life.
BMI, body mass index; CG, control group; DBP, diastolic blood pressure; HbA1c, glycated hemoglobin A1c; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; PD, Project Dulce-only; PD-TE, Project Dulce technology-enhanced; SBP, systolic blood pressure.