Active for Life Year 5

ISRCTN	ISRCTN50133740
DOI	https://doi.org/10.1186/ISRCTN50133740
Protocol serial number	09/3005/04
Sponsor	University of Bristol (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (ref: 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 of protocol

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

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Active 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 acronym	AFLY5
Study objectives	A 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
Health condition(s) or problem(s) studied	Public health
Intervention	The 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 type	Behavioural
Primary outcome measure(s)	Measured 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
Key secondary outcome measure(s)	Measured 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
Completion date	30/09/2014

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	9 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	1500
Key inclusion criteria	State 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)
Key exclusion criteria	Private schools and special schools will be excluded
Date of first enrolment	01/04/2011
Date of final enrolment	30/09/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Bristol

Bristol
BS8 2BN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	24/07/2011		Yes	No
Protocol article	protocol update	24/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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