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Table 5 Changes in outcome variables ─ per-protocol analysis a

From: LINDA – a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial

Outcome variable

Intervention group (PP) Nb

Control group (CTRL) N = 1,338

Difference between groups (PP vs. CTRL)

 

%

%

pc

Change in physical activity level

(n = 629)

(n = 1,323)

0.003

Increased

30.0

23.1

 

No change

54.8

58.5

 

Decreased

15.1

18.4

 

Change in meal regularity

   

Breakfast

(n = 482)

(n = 1,332)

0.491

 More regular

22.6

20.0

 

 No change

58.3

60.2

 

 More irregular

19.1

19.7

 

Lunch

(n = 486)

(n = 1,336)

0.110

 More regular

29.8

25.0

 

 No change

46.1

48.5

 

 More irregular

24.1

26.5

 

Dinner

(n = 484)

(n = 1,334)

0.024

 More regular

24.6

22.6

 

 No change

50.0

45.3

 

 More irregular

25.4

32.1

 

Change in the bedtime before school-/work-days

(n = 266)

(n = 1,317)

0.016

Earlier

35.7

27.7

 

No change

34.6

35.2

 

Later

29.7

37.1

 
 

Median (IQR)

Median (IQR)

p d

Change in BMI

(n = 918)

(n = 1,294)

 

All

0.52 (1.53)

0.51 (1.75)

0.996

BMI classes (before the intervention):

   

 BMI < 18.5

0.71 (1.08)

0.62 (1.30)

0.495

 BMI 18.5–24.9

0.51 (1.48)

0.49 (1.57)

0.740

 BMI 25.0–29.9

0.45 (2.28)

0.62 (2.55)

0.929

 BMI ≥ 30

0.57 (2.94)

0.23 (3.80)

0.881

  1. aThe participants in the intervention arm who completed the questionnaire both at the baseline and at the end of the intervention period, were not excluded for pregnancy during the intervention period, AND chose to discuss healthy physical activity and/or dietary behaviors and/or sleeping behaviors with the study nurses.
  2. bThe size of the intervention group in the per-protocol analyses varied according to the outcome variable as follows: Regarding change in physical activity level, participants who chose to discuss (at least) their physical activity behaviors (n = 637) were included. A valid answer to the question assessing physical activity was given by n = 629. Regarding change in meal regularity, participants who chose to discuss (at least) their dietary behaviors (n = 486) were included. Regarding change in bedtime, participants who chose to discuss (at least) their sleeping behaviors (n = 269) were included. Regarding change in BMI, participants who chose to discuss either their physical activity or dietary behaviors or sleeping behaviors, or two or three of these (n = 957) were included.
  3. cPearson’s Chi-square test.
  4. dMann–Whitney test.
  5. PP = per-protocol, CTRL = control, IQR = interquartile range.