Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Kobayashi, Itsuro; Hida, Eisuke; Tango, Toshiro

doi:10.1186/1471-2458-13-467

Table 4 Mean change at 6th months from baseline in dietary data

From: Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

	Intervention			Control			Model 1 (crude)			Model 2 (adjusted)			Model 3 (adjusted)			Model 4 (adjusted)
	Mean	±	SE	Mean	±	SE	Difference	95%CI	p-value	Difference	95%CI	p-value	Difference	95%CI	p-value	Difference	95%CI	p-value
Energy intake-whole day (kcal)
LOCF¹⁾	−29	±	16	−7	±	17	−22	(−23 to 67)	0.364	−21	(−19 to 61)	0.333	−23	(−18 to 64)	0.283	−27	(−112 to 9)	0.222
CDS²⁾	−54	±	22	9	±	24	−54	(−10 to 117)	0.114	−50	(− 1 to 108)	0.085	−54	(− 1 to 108)	0.073	−53	(−151 to −12)	0.034
MI³⁾	−54	±	35	−20	±	38	−34	(−76 to 145)	0.519	−33	(−68 to 134)	0.493	−39	(−62 to 140)	0.420	−52	(−159 to 50)	0.321
Energy intake-breakfast (kcal)
LOCF¹⁾	19	±	11	10	±	12	8	(−41 to 24)	0.619	11	(−41 to 19)	0.480	11	(−41 to 20)	0.505	12	(−56 to 32)	0.598
CDS²⁾	17	±	15	23	±	17	6	(−39 to 51)	0.793	2	(−43 to 38)	0.909	0	(−42 to 41)	0.986	2	(−50 to 55)	0.922
MI³⁾	1	±	22	5	±	24	−5	(−59 to 68)	0.891	0	(−65 to 64)	0.988	−3	(−61 to 66)	0.937	2	(−72 to 62)	0.888
Energy intake-lunch (kcal)
LOCF¹⁾	−6	±	10	−6	±	10	0	(−28 to 29)	0.974	−1	(−26 to 27)	0.965	−3	(−24 to 30)	0.829	22	(−17 to 62)	0.567
CDS²⁾	−13	±	13	−2	±	14	−11	(−27 to 49)	0.570	−11	(−27 to 49)	0.551	−13	(−23 to 49)	0.488	−34	(−13 to 82)	0.178
MI³⁾	−16	±	21	−12	±	22	−3	(−56 to 64)	0.899	−6	(−48 to 58)	0.808	−11	(−41 to 63)	0.694	−24	(−34 to 80)	0.441
Energy intake-dinner (kcal)
LOCF¹⁾	−23	±	6	−4	±	6	−19	(−35 to −3)	0.031	−19	(−35 to −2)	0.040	−19	(−35 to −3)	0.030	−29	(−48 to −10)	0.007
CDS²⁾	−29	±	7	2	±	8	−31	(−51 to −11)	0.008	−31	(−51 to −11)	0.007	−37	(−58 to −16)	0.003	−41	(−61 to −20)	0.001
MI³⁾	−30	±	10	−7	±	11	−23	(−51 to 5)	0.136	−22	(−50 to 6)	0.147	−24	(−50 to 3)	0.110	−24	(−54 to 4)	0.114
Proportion of carbohydrate to total energy intake (%)
LOCF¹⁾	0.0	±	0.3	0.6	±	0.4	0.6	(−0.4 to 1.6)	0.246	0.7	(−0.3 to 1.6)	0.193	0.6	(−0.3 to 1.5)	0.205	0.2	(−1.0 to 1.3)	0.768
CDS²⁾	0.0	±	0.4	−0.5	±	0.4	0.4	(−0.6 to 1.5)	0.373	0.4	(−0.5 to 1.3)	0.390	0.3	(−0.5 to 1.2)	0.438	−0.3	(−1.1 to 0.6)	0.559
MI³⁾	−0.1	±	0.7	0.0	±	0.7	0.2	(−2.0 to 2.0)	0.883	0.0	(−2.0 to 2.1)	0.985	−0.1	(−1.8 to 2.0)	0.945	−0.3	(−1.7 to 2.3)	0.764
Proportion of protein to total energy intake (%)
LOCF¹⁾	0.2	±	0.1	0.2	±	0.1	0.0	(−0.3 to 0.3)	0.837	0.0	(−0.4 to 0.3)	0.764	0.1	(−0.4 to 0.2)	0.759	0.1	(−0.3 to 0.5)	0.633
CDS²⁾	0.3	±	0.1	0.3	±	0.1	0.0	(−0.4 to 0.4)	0.999	0.0	(−0.4 to 0.3)	0.862	0.0	(−0.4 to 0.4)	0.884	0.2	(−0.1 to 0.6)	0.257
MI³⁾	0.3	±	0.2	0.1	±	0.2	−0.2	(−0.9 to 0.5)	0.512	−0.2	(−0.8 to 0.5)	0.546	−0.2	(−0.8 to 0.5)	0.597	−0.3	(−0.3 to 0.6)	0.825
Proportion of total fat to total energy intake (%)
LOCF¹⁾	−0.2	±	0.3	0.3	±	0.3	−0.6	(−1.3 to 0.1)	0.152	−0.6	(−1.3 to 0.1)	0.111	−0.6	(−1.2 to 0.1)	0.110	−0.3	(−1.2 to 0.5)	0.435
CDS²⁾	−0.2	±	0.3	0.2	±	0.3	−0.5	(−1.3 to 0.4)	0.282	−0.4	(−1.1 to 0.3)	0.287	−0.3	(−0.9 to 0.3)	0.307	0.1	(−0.6 to −0.7)	0.861
MI³⁾	−0.2	±	0.6	−0.2	±	0.6	0.0	(−1.9 to 1.8)	0.755	−0.1	(−1.5 to 1.6)	0.941	0.0	(−1.4 to 1.5)	0.953	0.1	(−1.6 to 1.4)	0.900
Vegetable intake-whole day (g)
LOCF¹⁾	35.1	±	5.5	−0.2	±	5.7	35.3	(19.6 to 50.6)	0.000	29.0	(14.9 to 43.1)	0.001	28.6	(14.3 to 42.9)	0.001	25.5	(5.9 to 45.1)	0.021
CDS²⁾	43.2	±	6.3	5.4	±	7,1	37.8	(19.2 to 56.4)	0.001	31.4	(13.2 to 49.6)	0.003	30.1	(11.6 to 48.7)	0.005	28.6	(8.9 to 48.2)	0.011
MI³⁾	39.1	±	8.5	−1.4	±	9.3	40.5	(13.2 to 67.9)	0.007	31.6	(8.5 to 56.7)	0.021	31.6	(7.8 to 55.6)	0.024	30.5	(5.6 to 55.4)	0.034
Vegetable intake-breakfast (g)
LOCF¹⁾	16.0	±	2.8	−0.3	±	2.8	16.3	(8.6 to 23.9)	0.001	13.0	(5.9 to 20.0)	0.002	12.7	(6.5 to 18.9)	0.001	14.3	(4.6 to 23.7)	0.001
CDS²⁾	20.2	±	3.0	0.8	±	3.3	19.4	(10.5 to 28.3)	0.000	14.1	(6.3 to 21.9)	0.003	13.1	(5.3 to 20.9)	0.004	11.5	(1.1 to 21.5)	0.043
MI³⁾	15.5	±	4.2	−0.5	±	4.5	16.0	(3.9 to 28.3)	0.021	13.0	(−0.3 to 22.5)	0.078	12.7	(−0.2 to 21.3)	0.079	12.5	(−0.3 to 22.7)	0.062
Vegetable intake-lunch (g)
LOCF¹⁾	13.1	±	3.0	0.5	±	3.1	9.5	(4.2 to 21.0)	0.009	9.9	(2.2 to 16.9)	0.020	9.0	(1.7 to 16.4)	0.027	6.0	(4.3 to 16.2)	0.270
CDS²⁾	15.9	±	3.4	5.1	±	3.8	10.8	(10.8 to 20.8)	0.048	8.5	(−0.4 to 17.5)	0.078	8.0	(−1.2 to 17.2)	0.108	3.6	(−8.0 to 15.1)	0.550
MI³⁾	15.0	±	4.5	−0.3	±	4.9	15.3	(0.6 to 30.0)	0.042	10.9	(−2.3 to 24.1)	0.113	10.5	(−1.3 to 22.2)	0.106	9.8	(−2.1 to 21.7)	0.134
Vegetable intake-dinner (g)
LOCF¹⁾	6.4	±	2.8	−0.6	±	2.9	7.2	(−0.8 to 14.8)	0.095	5.8	(−1.5 to 13.1)	0.129	5.6	(−1.7 to 12.9)	0.144	4.2	(−4.8 to 13.3)	0.376
CDS²⁾	5.7	±	3.1	0.1	±	3.4	5.6	(−0.8 to 16.9)	0.093	6.0	(−2.4 to 14.9)	0.177	6.2	(−14.3 to 45.1)	0.174	3.1	(−5.9 to 45.1)	0.491
MI³⁾	8.3	±	3.9	−1.3	±	4.3	9.7	(−3.4 to 19.8)	0.132	8.2	(−3.4 to 19.8)	0.186	8.0	(−4.6 to 20.7)	0.196	8.2	(−3.8 to 20.2)	0.205
Dietary fiber intake (g)
LOCF¹⁾	0.7	±	0.2	0.1	±	0.2	0.6	(0.1 to 1.0)	0.022	0.5	(0.1 to 0.9)	0.039	0.5	(−0.1 to 1.0)	0.051	0.4	(0.0 to 1.0)	0.241
CDS²⁾	0.9	±	0.2	0.3	±	0.2	0.6	(0.0 to 1.2)	0.087	0.4	(−0.1 to 1.0)	0.157	0.4	(−0.2 to 1.0)	0.225	0.3	(−0.5 to 1.0)	0.489
MI³⁾	0.7	±	0.3	0.1	±	0.3	0.6	(−1.6 to 0.4)	0.246	0.4	(−1.4 to 0.5)	0.346	0.4	(−1.4 to 0.6)	0.380	0.4	(−1.3 to 0.6)	0.393

SE: standard error, 95%CI: 95% confidence interval, degree of freedom = 18.
^# Value of HbA_1C is JDS¹⁵.
1) LOCF: last observation carried forward (IG: n = 100, CG: n = 93).
2) CDS: complete data set. (IG: n = 84, CG: n = 70).
3) MI: Multiple imputation with all analyzed variables (number of imputations = 200) (IG: n = 100, CG: n = 93).
Model 1: crude.
Model 2: mixed model adjusted for baseline.
Model 3: mixed model adjusted for baseline, gender, age and BMI.
Model 4: mixed model adjusted for baseline, gender, age, BMI, smoking status, exercise status, change of exercise level, family history of type 2 diabetes, and complication.

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