Table 2.
Measured values | Intervention groupa | Intervention completers | Control groupa | |||||||||||||
|
6 months, mean (95% CI) | Effect sizeb | P valuec | 12 months, mean (95% CI) | Effect sizeb | P valuec | 6 months, mean (95% CI) | Effect sizeb | P valuec | 12 months, mean (95% CI) | Effect sizeb | P valuec | 6 months, mean (95% CI) | P valuec | 12 months, mean (95% CI) | P valuec |
Weight (kg) | −3.31 (−4.43 to −2.19) | −0.12 | <.001 | −2.22 (−3.31 to −1.13) | 0.01 | .02 | −4.86 (−6.39 to −3.33) | −0.22 | <.001 | −3.92 (−5.48 to −2.37) | −0.14 | <.001 | −0.42 (−1.53 to 0.69) | .45 | −0.09 (−1.30 to 1.11) | .88 |
Weight (%) | −3.69 (−4.89 to −2.48) | −0.63 | <.001 | −2.54 (−3.74 to −1.33) | −0.40 | <.001 | −5.59 (−7.22 to −3.95) | −0.99 | <.001 | −4.66 (−6.42 to −2.90) | −0.72 | <.001 | −0.15 (−1.42 to 1.11) | .81 | 0.33 (−1.06 to 1.72) | .63 |
BMI (kg/m2) | −1.35 (−1.79 to −0.92) | −0.13 | <.001 | −0.88 (−1.31 to 0.44) | −0.00 | <.001 | −1.79 (−2.34 to −1.24) | −0.15 | <.001 | −1.44 (−2.02 to −0.87) | −0.09 | <.001 | −0.12 (−0.53 to 0.29) | .56 | −0.04 (−0.47 to 0.39) | .86 |
HbA1cd (%) | −0.15 (−0.22 to −0.08) | 0.08 | <.001 | −0.23 (−0.32 to −0.14) | −0.13 | <.001 | −0.17 (−0.25 to −0.10) | −0.06 | <.001 | −0.28 (−0.37 to −0.19) | −0.38 | <.001 | −0.17 (−0.25 to −0.09) | <.001 | −0.16 (−0.27 to −0.05) | .01 |
aAt 6 months, the intervention group lost 2.64 kg more and had a BMI difference of 0.99 kg/m2 compared with the control group (both P<.001) in the intention-to-treat (ITT) maximum likelihood estimates missing data analyses. At 12 months, in the ITT analyses, the intervention group lost 1.8 kg more than the control group (P=.01) and had a BMI difference of 0.58 kg/m2 (P=.01). In the ITT analyses, HbA1c was not different between groups at 6 or 12 months, with a difference of 0.004% (P=.94) and 0.006% (P=.93), respectively.
b≤0.2=small effect; >0.2 to <0.8=medium effect; ≥0.8=large effect.
cP values were obtained from t tests using a .05 significance level.
dHbA1c: hemoglobin A1c.