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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.