Condition category
Not Applicable
Date applied
17/12/2010
Date assigned
17/03/2011
Last edited
20/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Debbie Lawlor

ORCID ID

Contact details

MRC Centre for Causal Analyses in Translational Epidemiology
University of Bristol
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
+44 (0)117 331 0096
d.a.lawlor@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/3005/04

Study information

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

Acronym

AFLY5

Study hypothesis

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

University of Bristol Faculty of Medicine and Dentistry Ethics Committee, approval pending as of 10/01/2011

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/04/2011

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

60 schools; ~1500 school children

Participant exclusion criteria

Private schools and special schools will be excluded

Recruitment start date

01/04/2011

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2BN
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

c/o Teirnan Williams
Research and Enterprise Department
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8483
Tiernan.Williams@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bris.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21781344
2013 protocol update in: http://www.ncbi.nlm.nih.gov/pubmed/23883177
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24865166
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26559131
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26801759
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27386615

Publication citations

  1. Protocol

    Lawlor DA, Jago R, Noble SM, Chittleborough CR, Campbell R, Mytton J, Howe LD, Peters TJ, Kipping RR, The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial., Trials, 2011, 12, 181, doi: 10.1186/1745-6215-12-181.

  2. Protocol update

    Lawlor DA, Peters TJ, Howe LD, Noble SM, Kipping RR, Jago R, The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan., Trials, 2013, 14, 1, 234, doi: 10.1186/1745-6215-14-234.

  3. Results

    Kipping RR, Howe LD, Jago R, Campbell R, Wells S, Chittleborough CR, Mytton J, Noble SM, Peters TJ, Lawlor DA, Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: active for Life Year 5 (AFLY5) school based cluster randomised controlled trial., BMJ, 2014, 348, g3256.

  4. Results

    Lawlor DA, Kipping RR, Anderson EL, Howe LD, Chittleborough CR, Moure-Fernandez A, Noble SM, Rawlins E, Wells SL, Peters TJ, Jago R, Campell R, 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, Public Health Research, 2016 .

Additional files

Editorial Notes

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