ISRCTN ISRCTN50133740
DOI https://doi.org/10.1186/ISRCTN50133740
Secondary identifying numbers 09/3005/04
Submission date
17/12/2010
Registration date
17/03/2011
Last edited
20/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Debbie Lawlor
Scientific

MRC Centre for Causal Analyses in Translational Epidemiology
University of Bristol
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom

Phone +44 (0)117 331 0096
Email d.a.lawlor@bristol.ac.uk

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleActive For Life Year 5: a cluster randomised controlled trial of a primary school-based intervention to increase levels of physical activity, decrease sedentary behaviour and improve diet
Study acronymAFLY5
Study hypothesisA school-based intervention (AFLY5) that consists of teacher training and delivery of 16 lessons with 10 related homeworks (all lesson and homework plans provided) increases levels of physical activity, decreases sedentary behaviour and increases consumption of fruit and vegetables in Year 5 school children.
Ethics approval(s)University of Bristol Faculty of Medicine and Dentistry Ethics Committee, approval pending as of 10/01/2011
ConditionPublic health
InterventionThe intervention is called 'Active for Life Year 5'. It consists of:
1. Training for classroom teachers
2. 16 lesson-plans including pictures, CDs and journals
3. 10 parental-child homework activities
4. Information for school newsletters
5. Information for parents on how to encourage their children to eat healthily and be active
6. A healthy activity day at school for parents, teachers and children

The control group will be 'standard lessons and school activity' for the duration of the study. Providing there is no evidence of harm the control group will be offered the intervention once the study is completed.

The total duration of the intervention is 8 months. Total duration of follow-up for both arms (both identical) is 24 months.
Intervention typeBehavioural
Primary outcome measureMeasured at baseline, 12 months and 24 months:
1. Accelerometer assessed moderate/vigorous physical activity
2. Accelerometer assessed mean sedentary time
3. Portions of fruit and vegetables consumed
Secondary outcome measuresMeasured at baseline, 12 months and 24 months:
1. Self-report of mean time spent screen-viewing
2. Portions of snacks, high-fat foods and high energy drinks consumed per day
3. Mean body mass index
4. Mean waist circumference
5. Odds of overweight/obesity
Overall study start date01/04/2011
Overall study end date30/09/2014

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit9 Years
Upper age limit10 Years
SexBoth
Target number of participants60 schools; ~1500 school children
Participant inclusion criteriaState Primary/Junior Schools in the South West of England. Within these schools the participants will be school children in Year 5 (9 - 10 year olds, either sex)
Participant exclusion criteriaPrivate schools and special schools will be excluded
Recruitment start date01/04/2011
Recruitment end date30/09/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Bristol
Bristol
BS8 2BN
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

c/o Teirnan Williams
Research and Enterprise Department
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Phone +44 (0)117 928 8483
Email Tiernan.Williams@bristol.ac.uk
Website http://www.bris.ac.uk/
ROR logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (ref: 09/3005/04)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 24/07/2011 Yes No
Protocol article protocol update 24/07/2013 Yes No
Results article results 27/05/2014 Yes No
Results article results 11/11/2015 Yes No
Results article results 22/01/2016 Yes No
Results article results 01/06/2016 Yes No

Editorial Notes

20/09/2016: Publication reference added.
11/07/2016: Publication reference added.
25/01/2016: Publication reference added.