Table 2.
Main intention to treat 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) | 603 | 55.25 (22.33) | 1252 | –1.35 (–5.29 to 2.59) | 0.50 | ||
| Time spent in sedentary behaviour (min/day) | 649 | 451.84 (65.40) | 603 | 454.08 (66.78) | 1252 | –0.11 (–9.71 to 9.49) | 0.98 | ||
| Servings of fruit and vegetables (No/day) | 1097 | 1.81 (1.55) | 1024 | 1.89 (1.70) | 2121 | 0.08 (–0.12 to 0.28) | 0.42 | ||
| Continuous outcomes (secondary)§ | |||||||||
| Time spent screen viewing (min/day weekday) | 1097 | 145.45 (133.95) | 1024 | 132.52 (125.37) | 2121 | –15.56 (–33.56 to 2.45) | 0.09 | ||
| Time spent screen viewing (min/day Saturday) | 1097 | 175.64 (171.79) | 1024 | 155.33 (154.43) | 2121 | –20.86 (–37.30 to –4.42) | 0.01 | ||
| Body mass index (z score¶) | 945 | 0.05 (1.03) | 880 | –0.05 (0.95) | 1825 | –0.02 (–0.08 to 0.03) | 0.41 | ||
| Waist circumference (z score¶) | 1027 | 0.08 (1.04) | 954 | –0.08 (0.94) | 1981 | –0.12 (–0.23 to –0.01) | 0.03 | ||
| Servings of snacks (No/day) | 1097 | 2.46 (1.59) | 1024 | 2.24 (1.49) | 2121 | –0.22 (–0.38 to –0.05) | 0.01 | ||
| Servings of high fat foods (No/day) | 1097 | 0.88 (0.96) | 1024 | 0.79 (0.97) | 2121 | –0.10 (–0.24 to 0.03) | 0.13 | ||
| Servings of high energy drinks (No/day) | 1097 | 2.45 (1.61) | 1024 | 2.21 (1.44) | 2121 | –0.26 (–0.43 to –0.10) | 0.002 | ||
| Binary outcomes | |||||||||
| Generally overweight/obese | 945 | 198 (21.05%) | 880 | 166 (18.9%) | 1825 | 0.89 (0.61 to 1.31) | 0.56 | ||
| Centrally overweight/obese | 1027 | 510 (49.7%) | 954 | 416 (43.6%) | 1981 | 0.72 (0.50 to 1.04) | 0.08 | ||
MVPA=moderate or vigorous physical activity; Np=number of participants.
In these analyses, 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.