Table 3.
Per protocol analyses of effect of AFLY5 intervention on primary and secondary outcomes assessed immediately after end of intervention
| Outcomes (primary/secondary) | Control (reference) group | Intervention group | Main comparison between two groups (intervention v control) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Np | Mean (SD) or No (%) | Np | Mean (SD) or No (%) | Np | Difference in means or odds ratio (95% CI)* | P value | |||
| Continuous outcomes (primary)† | |||||||||
| Time spent in MVPA‡ (min/day) | 649 | 56.65 (23.42) | 424 | 54.39 (21.55) | 1073 | –2.12 (–6.70 to 2.47) | 0.37 | ||
| Time spent in sedentary behaviour (min/day) | 649 | 451.84 (65.40) | 424 | 453.68 (67.42) | 1073 | 0.44 (–10.32 to 11.21) | 0.94 | ||
| Servings of fruit and vegetables (No/day) | 1097 | 1.81 (1.55) | 722 | 1.99 (1.77) | 1819 | 0.18 (–0.05 to 0.41) | 0.12 | ||
| Continuous outcomes (secondary)§ | |||||||||
| Time spent screen viewing (min/day weekday) | 1097 | 145.45 (133.95) | 722 | 124.20 (118.88) | 1819 | –19.11 (–39.59 to 1.37) | 0.07 | ||
| Time spent screen viewing (min/day Saturday) | 1097 | 175.64 (171.79) | 722 |
146.99 (147.15) | 1819 | –24.61 (–42.06 to –7.17) | 0.006 | ||
| Body mass index (z score¶) | 945 | 0.05 (1.03) | 613 | –0.05 (0.96) | 1558 | –0.01 (–0.07 to 0.05) | 0.82 | ||
| Waist circumference (z score¶) | 1027 | 0.08 (1.04) | 665 | –0.06 (0.94) | 1692 | –0.09 (–0.21 to 0.04) | 0.17 | ||
| Servings of snacks (No/day) | 1097 | 2.46 (1.59) | 722 | 2.29 (1.54) | 1819 | –0.18 (–0.38 to 0.02) | 0.07 | ||
| Servings of high fat foods (No/day) | 1097 | 0.88 (0.96) | 722 | 0.86 (0.99) | 1819 | –0.04 (–0.19 to 0.11) | 0.62 | ||
| Servings of high energy drinks (No/day) | 1097 | 2.45 (1.61) | 722 | 2.18 (1.44) | 1819 | –0.29 (–0.48 to -0.09) | 0.005 | ||
| Binary outcomes | |||||||||
| Generally overweight/obese | 945 | 198 (21.0%) | 613 | 111 (18.1%) | 1558 | 0.96 (0.62 to 1.48) | 0.84 | ||
| Centrally overweight/obese | 1027 | 510 (49.7%) | 665 | 295 (44.4%) | 1692 | 0.87 (0.58 to 1.32) | 0.52 | ||
MVPA=moderate or vigorous physical activity; Np=number of participants.
Per protocol analysis defined as teaching at least 70% (11/16) AFLY5 lessons. All participants from intervention classes where teacher taught fewer than 11 (70%) lessons were excluded from these analyses (children from 16 classes (from 12 schools) were excluded).
In these analyses, after removal of schools that did not teach at least 11 out of 16 lessons, participants were included for each outcome if they had a follow-up measurement of that outcome; for missing baseline data, an indicator variable was used,46 which means that for each outcome participants are included even if they do not have a baseline measurement.
*Estimated using multi-level models to account for clustering (non-independence) among children from same school; multi-level multivariable linear regression was used for effects of intervention on continuously measured outcomes and multi-level multivariable logistic regression was used for binary outcomes; baseline/school stratifying variables were age, sex, baseline measure of outcome under consideration, school involvement in other health promoting behaviours, and school area level deprivation.
†P<0.05 indicates statistical significance.
‡Assessed by accelerometer.
§P<0.01 indicates statistical significance after account taken of multiple testing.
¶Internally standardised.