Characteristic | N | Statistic |
---|---|---|
Setting | ||
 Country | 24 |  |
  England, n (%) |  | 18 (75) |
  Scotland, n (%) |  | 1 (4) |
  Wales, n (%) |  | 2 (8) |
  Northern Ireland, n (%) |  | 3 (13) |
 School types that were included [51][Accessed 1st September 2021] a | 15 |  |
  State, n (%) |  | 14 (93) |
  Academy, n (%) |  | 3 (20) |
  Voluntary aided, n (%) |  | 1 (7) |
  Foundation, n (%) |  | 1 (7) |
  Faith, n (%) |  | 1 (7) |
  Grammar, n (%) |  | 1 (7) |
  Independent, n (%) |  | 1 (7) |
Intervention | ||
 Type of intervention [1] b | 24 |  |
  Individual-cluster, n (%) |  | 2 (8) |
  Professional-cluster, n (%) |  | 18 (75) |
  External-cluster, n (%) |  | 8 (33) |
  Cluster–cluster, n (%) |  | 23 (96) |
  Multifaceted, n (%) |  | 21 (88) |
 Intervention componentsc | 24 |  |
  Resources and materials for schools, n (%) |  | 11 (46) |
  Classroom lessons, n (%) |  | 10 (42) |
  Physical activity lessons, n (%) |  | 5 (21) |
  Incentive scheme, n (%) |  | 4 (17) |
  Change in school/classroom environment, n (%) |  | 4 (17) |
  Peer support, n (%) |  | 3 (13) |
  Support for parents/guardians, n (%) |  | 3 (13) |
  Goal setting, n (%) |  | 2 (8) |
  Staff training, n (%) |  | 2 (8) |
  Home activities, n (%) |  | 2 (8) |
  Extracurricular physical activity, n (%) |  | 2 (8) |
  Parent’s evenings, n (%) |  | 1 (4) |
  Drama workshops, n (%) |  | 1 (4) |
  Funding, n (%) |  | 1 (4) |
  School action group formation, n (%) |  | 1 (4) |
  School club sessions, n (%) |  | 1 (4) |
  Screening, n (%) |  | 1 (4) |
  Feedback, n (%) |  | 1 (4) |
  Motivational interviews, n (%) |  | 1 (4) |
  Interactive sessions, n (%) |  | 1 (4) |
  Discussions with parents/guardians, n (%) |  | 1 (4) |
  Gamification (competitive) techniques, n (%) |  | 1 (4) |
 Type of control group | 24 |  |
  Usual care, n (%) |  | 21 (88) |
  Active, n (%) |  | 2 (8) |
  Two control groups (one usual care and one active control), n (%) |  | 1 (4) |
Study design | ||
 Justification for CRT design | 24 |  |
  Yes, n (%) |  | 5 (21) |
 Type of randomisation | 24 |  |
  Completely randomised, n (%) |  | 11 (46) |
  Minimisation, n (%) |  | 5 (21) |
  Stratified, n (%) |  | 4 (17) |
  Matched pair, n (%) |  | 3 (13) |
 | 1 (4) | |
 Number of trial conditions | 24 |  |
  Two, n (%) |  | 21 (88) |
  Three, n (%) |  | 2 (8) |
  Four, n (%) |  | 1 (4) |
 Length of follow-up | 24 |  |
  Up to 6 months, n (%) |  | 11 (46) |
  7 to 12 months, n (%) |  | 8 (33) |
  13 to 18 months, n (%) |  | 3 (13) |
  More than 18 months, n (%) |  | 1 (4) |
  Not stated, n (%) |  | 1 (4) |
 Were pupils recruited before randomisation of clusters? | 24 |  |
  Pupils recruited before randomisation, n (%) |  | 12 (50) |
  Pupils recruited after randomisation, n (%) |  | 4 (17) |
  Unclear, n (%) |  | 8 (33) |
 Were baseline cluster-level characteristics reported? | 24 |  |
  Yes, n (%) |  | 13 (54) |
Ethical approval | ||
 Was ethical approval obtained? | 24 |  |
  Yes, n (%) |  | 22 (92) |
  No, n (%) |  | 1 (4) |
  Not stated, n (%) |  | 1 (4) |
Sample size | ||
 Type of justification for sample size | 24 |  |
  Formal sample size calculationd, n (%) |  | 3 (13) |
  Other justification, n (%) |  | 19 (79) |
  Not stated, n (%) |  | 2 (8) |
 Target number of schools, median (IQR; range) | 18 | 7.5 (5 to 8; 2 to 20) |
 Target number of clusters, median (IQR; range) | 18 | 7.5 (5 to 8; 2 to 20) |
 Target number of pupils, median (IQR; range) | 13 | 320 (150 to 1200; 50 to 1852) |
 Achieved number of schools, median (IQR; range) | 24 | 7.5 (4.5 to 9; 2 to 37) |
 Achieved number of clusters, median (IQR; range) | 24 | 8 (5.5 to 9.5; 2 to 37) |
 Achieved number of pupils, median (IQR; range) | 24 | 274 (179 to 557; 29 to 1567) |
 Achieved mean cluster size, median (IQR; range) | 24 | 35.9 (24 to 89.4; 1.4 to 237.7) |
Objectives of the feasibility study | ||
 Feasibility objectives | 24 |  |
  Test randomisation process, n (%) |  | 3 (13) |
  Test data collection process, n (%) |  | 8 (33) |
  Test willingness to be randomised (at cluster level and/or individual levels), n (%) |  | 4 (17) |
  Estimate recruitment percentage (at cluster level and/or individual levels), n (%) |  | 15 (63) |
  Estimate follow-up percentage (at cluster level and/or individual levels), n (%) |  | 15 (63) |
  Test implementation of intervention, n (%) |  | 10 (42) |
  Test compliance with intervention, n (%) |  | 6 (25) |
  Assess acceptability of intervention (at cluster level and/or individual levels), n (%) |  | 16 (67) |
  Assess acceptability of trial procedures (at cluster level and/or individual levels), n (%) |  | 6 (25) |
  Test the feasibility of blinding procedures, n (%) |  | 0 (0) |
  Test outcome measures, n (%) |  | 14 (58) |
  Estimate standard deviation of continuous outcomes or control arm rate for binary outcomes, n (%) |  | 1 (4) |
  Test consent procedures, n (%) |  | 0 (0) |
  Identify potential harms, n (%) |  | 3 (13) |
  Assess potential effectiveness of intervention, n (%) |  | 17 (71) |
  Estimate intervention cost, n (%) |  | 7 (29) |
  Estimate the ICC of the primary outcome, n (%) |  | 2 (8) |
  Estimate sample size for definitive trial, n (%) |  | 5 (21) |
Other study characteristics of methodological interest | ||
 Analysis method for estimating potential effectiveness | 24 |  |
  Individual-level analysis that allows for clustering, n (%) |  | 9 (38) |
  Cluster-level analysis, n (%) |  | 4 (17) |
  Did not account for clustering, n (%) |  | 4 (17) |
  Not stated, n (%) |  | 3 (13) |
  Did not estimate potential effectiveness, n (%) |  | 4 (17) |
 P-value reported for effectiveness | 24 |  |
 Yes, n (%) |  | 8 (33) |