Table 2 Results of the primary and secondary endpoints after 6 and 12 months

From: Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial

Parameters

Mean (s.d.; n)

Difference between lifestyle intervention and usual care

Lifestyle intervention

Usual care

Visit

Change from baseline

Visit

Change from baseline

Mean (95% CI; n)

P value

HbA1c (%)

 Baseline

6.79 (0.89; 248)

–

6.92 (0.97; 248)

–

–

–

 6 months

6.68 (0.85; 200)

−0.13 (0.61; 197)

6.78 (0.78; 193)

0.00 (0.59; 193)

−0.13 (−0.25 to −0.01; 390)

0.04

 12 months

6.84 (0.86; 180)

0.03 (0.72; 178)

6.85 (0.84; 174)

0.04 (0.67; 174)

−0.01 (−0.16 to 0.14; 352)

0.90

Body weight (kg)

 Baseline

92.2 (17.4; 251)

–

91.4 (15.9; 248)

–

–

–

 6 months

90.0 (17.3; 201)

−2.2 (3.7; 201)

91.2 (15.5; 196)

−0.8 (3.2; 196)

−1.4 (−2.1 to −0.8; 397)

<0.001

 12 months

89.4 (17.5; 187)

−2.2 (4.9; 187)

90.5 (15.8; 183)

−1.5 (4.3; 183)

−0.8 (−1.7 to 0.2; 370)

0.12

Waist circumference (cm)

 Baseline

107.8 (13.0; 243)

–

108.0 (11.9; 237)

–

–

–

 6 months

106.3 (13.2; 189)

−1.5 (5.0; 187)

107.5 (12.0; 192)

−0.7 (5.3; 184)

−0.7 (−1.8 to 0.3; 371)

0.18

 12 months

106.8 (13.0; 174)

−0.6 (5.5; 169)

107.1 (12.6; 171)

−1.4 (6.1; 165)

0.8 (−0.4 to 2.1; 334)

0.20

Systolic blood pressure (mm Hg)

 Baseline

137 (17; 251)

–

138 (18; 248)

–

–

–

 6 months

133 (17; 201)

−5 (16; 201)

135 (17; 195)

−2 (18; 195)

−2 (−6 to 1; 396)

0.17

 12 months

136 (19; 180)

−1.2 (18.4; 180)

135 (16; 175)

−2 (18; 175)

1 (−3 to 4; 355)

0.77

Diastolic blood pressure (mm Hg)

 Baseline

78 (10; 251)

–

80 (10; 248)

–

–

–

 6 months

78 (9; 201)

0 (10; 201)

78 (10; 195)

−1 (11; 195)

0 (−2 to 3; 396)

0.63

 12 months

79 (10; 180)

1 (11; 180)

78 (10; 175)

−1 (11; 175)

2 (−1 to 4; 355)

0.14

HDL cholesterol (mg dl−1)

 Baseline

48 (14; 250)

–

47 (12; 248)

–

–

–

 6 months

49 (14; 200)

1 (12; 199)

46 (12; 194)

0 (8; 194)

2 (0–4; 393)

0.12

 12 months

49 (12; 179)

0 (10; 179)

46.9 (11.8; 175)

0.6 (6.6; 175)

−0.4 (−2.2 to 1.4; 354)

0.64

LDL cholesterol (mg dl−1)

 Baseline

91 (36; 250)

–

93 (32; 246)

–

–

–

 6 months

84 (30; 200)

−5 (23; 199)

87 (34; 194)

−6 (26; 192)

1 (−4 to 6; 391)

0.69

 12 months

78 (28; 179)

−10 (31; 179)

85.7 (34.6; 175)

−8.3 (29.9; 173)

−1.6 (−8.0 to 4.7; 352)

0.61

Triglycerides (mg dl−1)

 Baseline

177 (101; 249)

–

188 (98; 248)

–

–

–

 6 months

158 (84; 200)

−22 (72; 198)

178 (109; 194)

−10 (79; 194)

−12 (−27 to 3; 392)

0.12

 12 months

157 (85; 178)

−15 (74; 177)

176 (115; 174)

−11 (89; 174)

−4 (−21 to 14; 351)

0.68

SF-36 physical component score (QoL)a

 Baseline

43.9 (10.2; 202)

–

45.1 (9.3; 191)

–

–

–

 6 months

46.5 (9.4; 157)

0.9 (8.3; 133)

46.9 (9.2; 163)

1.4 (6.2; 128)

−0.5 (−2.3 to 1.3; 261)

0.58

 12 months

46.7 (9.3; 150)

2.0 (8.3; 123)

45.6 (10.2; 147)

0.7 (8.0; 121)

1.3 (−0.7 to 3.4; 244)

0.20

SF-36 mental component score (QoL)a

 Baseline

52.0 (9.3; 202)

–

52.5 (9.0; 191)

–

–

–

 6 months

53.0 (8.6; 157)

1.0 (8.2; 133)

51.1 (9.3; 163)

−1.6 (7.3; 128)

2.7 (0.8–4.6; 261)

0.006

 12 months

51.4 (10.4; 150)

−0.6 (8.7; 123)

51.3 (10.0; 147)

−1.9 (8.8; 121)

1.3 (−0.9 to 3.5; 244)

0.23

HLS-EU-Q16—health literacyb

 Baseline

12.2 (3.6; 232)

–

12.6 (3.0; 227)

–

–

–

 6 months

12.5 (3.5; 181)

0.5 (3.1; 171)

12.5 (3.0; 177)

−0.1 (2.6; 166)

0.6 (0.0–1.2; 337)

0.04

 12 months

12.6 (3.2; 167)

0.5 (3.1; 158)

12.7 (3.2; 156)

0.0 (2.8; 147)

0.5 (−0.2 to 1.2; 305)

0.14

TFEQ—cognitive restraint of eatingc

 Baseline

7.6 (4.1; 232)

–

7.8 (3.7; 225)

–

–

–

 6 months

8.9 (4.4; 185)

1.2 (3.3; 175)

7.6 (3.7; 176)

0.2 (3.5; 161)

1.1 (0.3–1.8; 336)

0.005

 12 months

8.4 (4.2; 169)

0.9 (3.4; 159)

7.8 (3.9; 159)

0.2 (3.1; 147)

0.7 (0.0–1.4; 306)

0.06

TFEQ—disinhibitiond

 Baseline

4.4 (2.9; 234)

–

4.7 (3.0; 228)

–

–

–

 6 months

4.2 (2.7; 188)

−0.4 (1.9; 178)

4.5 (2.9; 178)

−0.1 (2.0; 166)

−0.2 (−0.6 to 0.2; 344)

0.32

 12 months

4.0 (2.7; 169)

−0.5 (1.9; 159)

4.1 (2.7; 161)

−0.5 (2.1; 151)

−0.1 (−0.5 to 0.4; 310)

0.81

TFEQ—hungere

 Baseline

3.5 (2.9; 235)

–

3.9 (3.0; 228)

–

–

–

 6 months

3.2 (2.7; 189)

−0.5 (2.0; 180)

3.5 (3.0; 179)

−0.6 (2.0; 166)

0.1 (−0.3 to 0.5; 346)

0.61

 12 months

3.2 (2.7; 169)

−0.6 (2.1; 160)

3.2 (2.9; 161)

−0.6 (2.1; 151)

0.1 (−0.4 to 0.5; 311)

0.80

IPAQ—MET min

 Baseline

3,922 (2,964; 109)

–

3,173 (2,869; 119)

–

–

–

 6 months

5,364 (3,592; 98)

1,447 (2,997; 56)

4,240 (3,568; 100)

1,129 (3,652; 56)

317 (−934 to 1,568; 112)

0.62

 12 months

5,092 (3,899; 98)

808 (4,060; 54)

3,906 (3,048; 97)

925 (2,781; 54)

−117 (−1,445 to 1,211; 108)

0.86

Daily steps

 Baseline

5,617 (3,195; 179)

–

5,761 (3,131; 151)

–

–

–

 6 months

6,112 (3,320; 151)

270 (2,726; 136)

5,833 (3,668; 144)

−49 (2,861; 119)

319 (−370 to 1,009; 255)

0.36

 12 months

5,987 (3,298; 105)

−132 (2,971; 92)

5,540 (3,581; 118)

−241 (3,003; 95)

109 (−753 to 971; 187)

0.80

  1. All outcomes presented in this table were evaluated with two-sided t tests for independent samples and were not adjusted for multiple comparisons. The exact P value for change in body weight at 6 months was 3.779 × 10−5.
  2. aHigher scores indicate better QoL (score range = 0–100).
  3. bHigher scores indicate better health literacy (score range = 0–16).
  4. cHigher scores indicate better cognitive restraint (score range = 0–21).
  5. dHigher scores indicate worse control (score range = 0–16).
  6. eHigher scores indicate higher susceptibility for internal and external hunger signs (score range = 0–14).
  7. MET, metabolic equivalent of task.
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