Table 1

Biochemical and clinical outcomes at baseline, and 12 months, by study group

Intervention groupControl groupAvailable case analysis
OutcomesNMean±SDNMean±SDICC*Adjusted difference between change scores (95% CI)†p Value
Primary outcome
HbA1c (%)
 Baseline35910.60±2.0932310.29±1.71
 12 months2956.67±1.692826.64±1.59
 Mean change from baseline to 12 months (95% CI)−3.86 (−4.16 to −3.56)−3.69 (−3.93 to −3.44)0.290.02 (−0.40 to 0.44)0.929
Secondary outcomes
Weight (kg)
 Baseline35970.13±11.7133369.68±10.27
 12 months30370.10±11.7429269.51±9.97
 Mean change from baseline to 12 months (95% CI)+0.13 (−0.15 to 0.41)+0.32 (0.06 to 0.58)0.07−0.09 (−0.58 to 0.40)0.723
BMI (kg/m2)
 Baseline35926.23±3.6933326.03±3.42
 12 months30226.22±3.7029226.13±3.44
 Mean change from baseline to 12 months (95% CI)+0.05 (−0.05 to 0.16)+0.13 (0.03 to 0.22)0.07−0.03 (−0.21 to 0.15)0.734
Waist (cm) men
 Baseline17693.75±9.2915392.82±8.49
 12 months14192.21±9.3612492.85±8.07
 Mean change from baseline to 12 months (95% CI)−0.88 (−1.48 to −0.27)+0.56 (−0.04 to 1.15)0.20−1.28 (−2.46 to −0.11)0.032
Waist (cm) women
 Baseline18688.57±9.5717690.68±10.02
 12 months16388.14±9.1616790.90±9.20
 Mean change from baseline to 12 months (95% CI)−0.05 (−0.69 to 0.59)+0.32 (−0.33 to 0.97)0.17−0.92 (−1.95 to 0.11)0.080
Hip (cm) men
 Baseline176102.37±8.69153100.23±7.71
 12 months140102.40±9.08125100.54±7.25
 Mean change from baseline to 12 months (95% CI)+0.11 (−0.52 to 0.74)+0.92 (0.18 to 1.66)0.23−0.03 (−1.34 to 1.29)0.967
Hip (cm) women
 Baseline18699.95±8.23179102.06±8.81
 12 months162100.19±8.27166102.41±8.78
 Mean change from baseline to 12 months (95% CI)+0.31 (−0.32 to 0.94)+0.55 (−0.06 to 1.16)0.22−0.36 (−1.58 to 0.85)0.557
Systolic blood pressure (mm Hg)
 Baseline363129.03±15.14334128.46±14.82
 12 months305127.79±11.71292130.96±12.37
 Mean change from baseline to 12 months (95% CI)−1.57 (−3.17 to 0.04)+2.40 (0.89 to 3.91)0.07−3.57 (−6.08 to −1.05)0.005‡
Diastolic blood pressure (mm Hg)
 Baseline36376.91±9.1033476.00±8.64
 12 months30577.46±7.0529276.95±7.23
 Mean change from baseline to 12 months (95% CI)+0.17 (−0.72 to 1.06)+1.04 (0.00 to 2.08)0.13−0.50 (−2.18 to 1.18)0.559
Fasting plasma glucose (mmol/L)
 Baseline3678.27±2.703308.13±2.74
 12 months2977.89±2.692877.93±2.57
 Mean change from baseline to 12 months (95% CI)−0.41 (−0.73 to −0.09)−0.21 (−0.52 to 0.11)0.07−0.11 (−0.64 to 0.42)0.685
Total cholesterol (mmol/L)
 Baseline3635.46±1.123265.40±1.19
 12 months3005.20±1.042875.23±1.23
 Mean change from baseline to 12 months (95% CI)−0.27 (−0.40 to −0.14)−0.12 (−0.26 to 0.03)0.10−0.10 (−0.35 to 0.16)0.456
Triglycerides (mmol/L)
 Baseline3631.91±1.533261.82±1.43
 12 months3001.63±1.102871.62±1.27
 Mean change from baseline to 12 months (95% CI)−0.27 (−0.40 to −0.14)−0.21 (−0.38 to −0.03)0.00 (−0.18 to 0.18)0.990
LDL cholesterol (mmol/L)
 Baseline3673.70±1.213293.56±1.13
 12 months3003.34±0.992863.25±1.01
 Mean change from baseline to 12 months (95% CI)−0.39 (−0.53 to −0.25)−0.26 (−0.42 to −0.11)0.29−0.07 (−0.34 to 0.19)0.593
HDL cholesterol (mmol/L) men
 Baseline1781.04±0.311511.08±0.27
 12 months1381.09±0.331251.11±0.33
 Mean change from baseline to 12 months (95% CI)+0.07 (0.01 to 0.13)+0.02 (−0.05 to 0.09)0.240.04 (−0.06 to 0.15)0.433
HDL cholesterol (mmol/L) women
 Baseline1891.17±0.351791.17±0.32
 12 months1611.19±0.351621.25±0.34
 Mean change from baseline to 12 months (95% CI)+0.03 (−0.03 to 0.09)+0.09 (0.02 to 0.15)0.340.00 (−0.11 to 0.11)0.944
  • *ICC, intracluster correlation coefficients indicated with a ‘−’ were truncated at zero.

  • †Differences between groups were estimated by multilevel regression, adjusting for clustering and baseline covariates of age group (less than 60 years/60 years or above), gender (male/female), chronic comorbidity category (diabetes only/diabetes plus other/s), time since diabetes diagnosis (<5 years/5–9 years/10–14 years/15 years or more), education level (primary school or less/secondary or high school/tertiary education) and residential address socioeconomic status (developed areas/developing areas/less developed areas).

  • ‡Multiple imputation for missing dependent variable values produced the same results.

  • BMI, body mass index; HbA1c; glycated haemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein.