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. 2016 Jan 5;11(1):e0146095. doi: 10.1371/journal.pone.0146095

Table 4. Nine-year changes in body weight (BW), body mass index (BMI) and waist circumference (WC): adjusted estimates (mean, Δ, RR).

Outcomes Analysis on dataset Intervention group Control group Intention-to-treat analysis: intervention versus control
Continuous N Mean 95% CI p N Mean 95% CI p N Δ 95% CI p
BW (kg) available 125 +3.1 +1.3 to +4.8 0.001 134 +5.1 +3.5 to +6.8 <0.001 259 -2.1 -4.1 to -0.1 0.043
BW (kg) imputed - +3.1 +1.5 to +4.7 <0.001 - +5.3 +3.6 to +7.0 <0.001 - -2.2 -4.6 to +0.2 0.073
BMI (kg/m²) available 125 +1.11 +0.44 to +1.77 0.002 132 +1.90 +1.26 to +2.54 <0.001 257 -0.79 -1.57 to -0.01 0.046
BMI (kg/m²) imputed - +1.19 +0.59 to +1.79 <0.001 - +2.00 +1.37 to +2.63 <0.001 - -0.81 -1.69 to +0.08 0.074
WC (cm) available 124 +1.9 +0.1 to +3.7 0.043 134 +4.8 +3.0 to +6.5 <0.001 258 -2.9 -5.0 to -0.8 0.008
WC (cm) imputed - +2.1 +0.3 to +3.9 0.022 - +4.5 +2.8 to +6.1 <0.001 - -2.4 -4.7 to -0.0 0.046
Binary Dataset n/N Pr 95% CI p n/N Pr 95% CI p N RR 95% CI p
BW loss available 40/125 0.32 0.24 to 0.41 <0.001 28/134 0.21 0.14 to 0.29 <0.001 259 1.60 1.04 to 2.46 0.032
BW loss imputed - 0.35 0.27 to 0.43 <0.001 - 0.25 0.17 to 0.32 <0.001 - 1.50 1.02 to 2.22 0.040
BW loss ≥ 5% available 21/125 0.17 0.11 to 0.25 <0.001 12/134 0.09 0.05 to 0.15 <0.001 259 1.83 0.90 to 3.71 0.096
BW loss ≥ 5% imputed - 0.19 0.13 to 0.26 <0.001 - 0.12 0.06 to 0.18 <0.001 - 1.66 0.91 to 3.02 0.100
BMI reduction available 40/125 0.32 0.24 to 0.41 <0.001 27/132 0.20 0.14 to 0.28 <0.001 257 1.61 1.04 to 2.50 0.032
BMI reduction imputed - 0.35 0.27 to 0.43 <0.001 - 0.24 0.17 to 0.32 <0.001 - 1.49 1.01 to 2.20 0.046
WC reduction available 55/124 0.44 0.35 to 0.54 <0.001 36/134 0.27 0.20 to 0.35 <0.001 258 1.60 1.13 to 2.25 0.007
WC reduction imputed - 0.44 0.36 to 0.52 <0.001 - 0.30 0.22 to 0.37 <0.001 - 1.46 1.06 to 2.00 0.019

95% CI = 95% confidence interval. Pr = univariate proportion (= n/N). RR = adjusted relative risk (intervention group as exposure category versus control group as reference category). BW loss ≥ 5% of the inclusion measurement. Continuous outcome within group = follow-up measurement minus inclusion measurement. Δ = intergroup difference in mean change (intervention minus control). p for test with (H0: mean = 0) or (H0: Δ = 0) or (H0: Pr = 0) or (H0: RR = 1) according to outcome and comparison. All results, except Pr, were adjusted on baseline characteristics (gender, age, BW or BMI or WC, HbA1c, occupation, stress). Missing data were imputed under MAR assumption with MICE method implemented in Stata 10 (ice and Micombine packages). Variables included in the imputation models: baseline characteristics, exposure-group, participation in the medical visit at trial completion (yes/no), and the shifted log transformation of BW and WC at follow-up, respectively. Forty imputed datasets were generated from an original dataset of 432 observations.