Table 2

Summary of clinical and patient report measures by arm and timepoint, and signal of efficacy estimates

InterventionControlUnadjusted 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)2560.6 (11.4)58.2 (13.2)−2.4 (8.7)2659.1 (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 (%)257.68 (1.06)7.48 (1.20)−0.20 (0.79)267.56 (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)25104.8 (13.9)105.8 (14.2)1.0 (5.8)25109.5 (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)2588.0 (18.5)87.6 (18.8)−0.4 (2.9)2695.6 (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)2532.7 (6.0)32.6 (6.3)−0.1 (1.1)2634.9 (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)24135.6 (13.2)132.3 (15.5)−3.3 (11.7)26134.1 (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)2474.8 (9.1)73.8 (12.6)−1.0 (9.5)2675.2 (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)254.25 (1.10)4.18 (1.09)−0.07 (0.59)264.32 (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)251.30 (0.43)1.42 (0.53)0.11 (0.21)261.31 (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)252.36 (0.76)2.26 (0.74)−0.09 (0.48)262.50 (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)251.51 (1.00)1.11 (0.41)−0.40 (0.91)261.10 (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 knowledge246.50 (2.28)7.17 (2.53)0.67 (1.95)256.92 (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 competence237.80 (0.78)8.29 (1.08)0.49 (0.94)267.93 (0.82)8.21 (0.99)0.28 (0.87)0.21 (−0.31 to 0.73)0.17 (−0.34 to 0.67)
 Empowerment233.77 (0.48)3.88 (0.65)0.10 (0.58)243.75 (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 life2463.8 (20.3)74.6 (16.6)10.8 (19.5)2664.0 (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 distress246.33 (6.45)5.29 (4.89)−1.04 (5.40)267.35 (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 support2462.2 (16.9)61.3 (19.9)−0.9 (13.9)2561.1 (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.