Table 2.
Summary of clinical and patient report measures by arm and timepoint, and signal of efficacy estimates
| Intervention | Control | Unadjusted mean difference† (95% CI) |
Baseline-adjusted mean difference† (95% CI) |
|||||||
| N* | Mean baseline (SD) |
Mean end point (SD) |
Mean change (SD) |
N* | Mean baseline (SD) |
Mean end point (SD) |
Mean change (SD) |
|||
| Clinical outcomes | ||||||||||
| HbA1c (mmol/mol) | 25 | 60.6 (11.4) | 58.2 (13.2) | −2.4 (8.7) | 26 | 59.1 (11.2) | 59.6 (18.4) | 0.5 (14.1) | −2.8 (−9.4 to 3.8) | −2.8 (−9.5 to 3.9) |
| HbA1c (%) | 25 | 7.68 (1.06) | 7.48 (1.20) | −0.20 (0.79) | 26 | 7.56 (1.04) | 7.60 (1.68) | 0.05 (1.30) | −0.25 (−0.86 to 0.36) | −0.24 (−0.86 to 0.37) |
| Waist circumference (cm) | 25 | 104.8 (13.9) | 105.8 (14.2) | 1.0 (5.8) | 25 | 109.5 (14.5) | 111.2 (13.4) | 1.7 (8.3) | −0.7 (−4.8 to 3.3) | −1.5 (−5.5 to 2.5) |
| Weight (kg) | 25 | 88.0 (18.5) | 87.6 (18.8) | −0.4 (2.9) | 26 | 95.6 (18.2) | 94.9 (18.6) | −0.7 (3.7) | 0.3 (−1.6 to 2.2) | 0.3 (−1.6 to 2.3) |
| BMI (kg/m2) | 25 | 32.7 (6.0) | 32.6 (6.3) | −0.1 (1.1) | 26 | 34.9 (6.5) | 34.6 (6.5) | −0.3 (1.3) | 0.1 (−0.6 to 0.8) | 0.1 (−0.6 to 0.9) |
| SBP (mm Hg) | 24 | 135.6 (13.2) | 132.3 (15.5) | −3.3 (11.7) | 26 | 134.1 (16.6) | 131.2 (13.5) | −2.8 (14.6) | −0.4 (−8.0 to 7.2) | 0.2 (−6.5 to 6.9) |
| DBP (mm Hg) | 24 | 74.8 (9.1) | 73.8 (12.6) | −1.0 (9.5) | 26 | 75.2 (5.7) | 76.2 (7.1) | 1.0 (8.0) | −2.1 (−7.0 to 2.9) | −2.2 (−7.1 to 2.7) |
| Total cholesterol (mmol/L) | 25 | 4.25 (1.10) | 4.18 (1.09) | −0.07 (0.59) | 26 | 4.32 (0.87) | 4.13 (0.92) | −0.19 (0.60) | 0.12 (−0.22 to 0.45) | 0.11 (−0.22 to 0.43) |
| HDL (mmol/L) | 25 | 1.30 (0.43) | 1.42 (0.53) | 0.11 (0.21) | 26 | 1.31 (0.36) | 1.30 (0.34) | −0.01 (0.18) | 0.12 (0.01 to 0.23) | 0.12 (0.01 to 0.23) |
| LDL (mmol/L) | 25 | 2.36 (0.76) | 2.26 (0.74) | −0.09 (0.48) | 26 | 2.50 (0.69) | 2.37 (0.71) | −0.13 (0.51) | 0.04 (−0.24 to 0.32) | 0.00 (−0.26 to 0.27) |
| Triglycerides (mmol/L) | 25 | 1.51 (1.00) | 1.11 (0.41) | −0.40 (0.91) | 26 | 1.10 (0.49) | 1.00 (0.45) | −0.10 (0.38) | −0.30 (−0.69 to 0.09) | 0.00 (−0.22 to 0.23) |
| Patient-reported outcomes | ||||||||||
| Diabetes knowledge | 24 | 6.50 (2.28) | 7.17 (2.53) | 0.67 (1.95) | 25 | 6.92 (2.74) | 7.80 (2.43) | 0.88 (2.28) | −0.21 (−1.43 to 1.01) | −0.37 (−1.48 to 0.74) |
| Dietary competence | 23 | 7.80 (0.78) | 8.29 (1.08) | 0.49 (0.94) | 26 | 7.93 (0.82) | 8.21 (0.99) | 0.28 (0.87) | 0.21 (−0.31 to 0.73) | 0.17 (−0.34 to 0.67) |
| Empowerment | 23 | 3.77 (0.48) | 3.88 (0.65) | 0.10 (0.58) | 24 | 3.75 (0.43) | 3.78 (0.37) | 0.03 (0.43) | 0.07 (−0.23 to 0.37) | 0.08 (−0.19 to 0.36) |
| Quality of life | 24 | 63.8 (20.3) | 74.6 (16.6) | 10.8 (19.5) | 26 | 64.0 (15.2) | 74.0 (14.0) | 10.0 (12.9) | 0.8 (−8.6 to 10.1) | 0.7 (−6.8 to 8.2) |
| Diabetes distress | 24 | 6.33 (6.45) | 5.29 (4.89) | −1.04 (5.40) | 26 | 7.35 (5.86) | 6.38 (5.57) | −0.96 (5.81) | −0.08 (−3.28 to 3.12) | −0.64 (−3.22 to 1.94) |
| Social support | 24 | 62.2 (16.9) | 61.3 (19.9) | −0.9 (13.9) | 25 | 61.1 (16.6) | 66.0 (14.5) | 4.9 (9.2) | −5.8 (−12.6 to 1.0) | −5.6 (−12.1 to 1.0) |
Measurement tools for patient-reported outcomes: quality of life, EuroQol EQ5D-3L visual analog scale; diabetes distress, using the 5-item Problem Areas In Diabetes (PAID-5) scale; diabetes knowledge, using the Short Diabetes Knowledge Instrument; empowerment, using the Diabetes Empowerment Scale Short Form; dietary competence, using the Perceived Diabetes & Dietary Competence measure and social support, using the Multidimensional Scale of Perceived Social Support.
*Number with complete baseline and end point data.
†Intervention minus control.
BMI, body mass index; DBP, diastolic blood pressure; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SBP, systolic blood pressure.