Table 2.
Changes in efficacy outcomes between control and intervention groups at 3 months.
| Outcomes | Mean change from baseline | Adjusted mean difference to controla, mean (95% CI) | P valuea | P value for interaction (intervention x time)b | ||||||||
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Control group (n=94), mean (95% CI) | Intervention group (n=145), mean (95% CI) |
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| Glycemic parameters | ||||||||||||
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HbA1cc (%) | −0.28 (−0.42 to −0.13) | −0.63 (−0.77 to −0.50) | −0.30 (−0.50 to −0.11) | .003d | .001d | ||||||
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HbA1c (mmol/mol) | −3.02 (−4.62 to −1.42) | −6.93 (−8.38 to −5.48) | −3.32 (−5.50 to −1.15) | .003d | .001d | ||||||
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FPGe (mg/dL) | −2.41(−13.64 to 8.82) | −19.11 (−29.80 to −8.43) | −17.29 (−29.33 to −5.26) | .005d | .02d | ||||||
| Other metabolic parameters | ||||||||||||
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Weight (kg) | −0.88 (−2.65 to 0.90) | −0.63 (−1.02 to −0.24) | 0.22 (−1.26 to 1.71) | .77 | .35 | ||||||
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WCf (cm) | −0.88 (−1.61 to −0.16) | −0.93 (−1.46 to −0.40) | 0.30 (−0.62 to 1.22) | .52 | .76 | ||||||
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BMI (kg/m2) | −0.41 (−1.21 to 0.40) | −0.26 (−0.40 to −0.11) | 0.09 (−0.48 to 0.65) | .77 | .34 | ||||||
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Systolic BPg (mmHg) | 3.55 (1.30 to 5.81) | −0.20 (−2.30 to 1.90) | −3.66 (−6.57 to −0.76) | .01d | .003d | ||||||
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Diastolic BP (mmHg) | 0.68 (−0.94 to 2.30) | −2.02 (−3.47 to −0.57) | −2.77 (−4.92 to −0.62) | .01d | .08 | ||||||
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Total cholesterol (mg/dL) | −2.77 (−8.01 to 2.48) | −3.06 (−6.73 to 0.60) | −3.81 (−10.04 to 2.42) | .23 | .35 | ||||||
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Triglyceride (mg/dL) | −16.88 (−30.14 to −3.62) | −16.72 (−31.36 to −2.08) | −8.27 (−25.89 to 11.27) | .38 | .73 | ||||||
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HDLh cholesterol (mg/dL) | 0.24 (−1.35 to 1.84) | 2.44 (1.16 to 3.73) | 1.40 (−0.45 to 3.39) | .15 | .20 | ||||||
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LDLi cholesterol (mg/dL) | −0.16 (−4.60 to 4.28) | −2.99 (−6.03 to 0.04) | −4.46 (−9.62 to 0.69) | .09 | .10 | ||||||
| Questionnairesj |
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DTSQsk | 0.45 (−1.03 to 1.92) | 2.40 (1.22 to 3.58) | 2.21 (0.54 to 3.88) | .01d | .04d | ||||||
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MMAS-6l | 0.06 (−0.15 to 0.28) | 0.52 (0.31 to 0.74) | 0.31 (0.05 to 0.57) | .02d | .02d | ||||||
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Motivation | 0.04 (−0.11 to 0.20) | 0.39 (0.23 to 0.54) | 0.23 (0.03 to 0.42) | .02d | .01d | |||||
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Knowledge | 0.02 (−0.13 to 0.17) | 0.14 (0.00 to 0.28) | 0.12 (−0.03 to 0.28) | .12 | .08 | |||||
aAssessed using the analysis of covariance model with a fixed effect for intervention, and age and respective baseline value as covariates to calculate a least-squares estimate of the treatment difference.
bAssessed using the linear mixed model with fixed effects for age, sex, intervention, time (baseline and 3 months), respective baseline value, baseline value-by time interaction, intervention-by time interaction, and random effects with cluster (centers) and each participant.
cHbA1c: hemoglobin A1c.
dP<.05.
eFPG: fasting plasma glucose.
fWC: waist circumference.
gBP: blood pressure.
hHDL: high-density lipoprotein.
iLDL: low-density lipoprotein
jHigher DTSQs and MMAS-6 scores indicate a favorable state.
kDTSQs: Diabetes Treatment Satisfaction Questionnaire status version.
lMMAS-6: 6-item Morisky Medication Adherence Scale.