Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/04/2011
Date assigned
19/05/2011
Last edited
01/11/2011
Prospective/Retrospective
Retrospectively 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 Cris Glazebrook

ORCID ID

Contact details

Nottingham University Hospital
Division of Psychiatry
Behavioural Sciences
A Floor
South Block
Nottingham
NG72UH
United Kingdom
+44 (0)115 823 0420
cris.glazebrook@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial evaluating the implementation and effectiveness of schools-based programme to promote exercise self-efficacy in children with risk factors for obesity: Steps to Active Kids (STAK)

Acronym

STAK

Study hypothesis

Children receiving the STAK intervention will have lower body mass index (BMI), smaller waist circumference, higher levels of self-reported physical activity and higher exercise self-efficacy than children in the control group. Children in the asthma group will have better lung function as assessed by peak flow meter.

Ethics approval

The University of Nottingham Medical School Ethics Committee approved on 12th February 2010 reference (B/10/2009)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Obesity, asthma

Intervention

A stepped approach will be used for the intervention. Following initial screening all children who meet the inclusion criteria will, after informed consent of parent, complete Steps 1 and 2. Children who are above the 97th centile or above 91st centile for children with asthma will be invited to take part in Step 3.

Step 1: Participants will be given two ‘Street Dance’ DVDs which comprise 10 minute daily exercise sessions, including a warm up, learning a new dance move and a cool down. Each DVD covers a two week period (14 different sessions). Sessions have been designed to be short and intensive and have been modelled by an ethnically diverse group of children with a range of body sizes. Children will also be given an Activity Diary to complete which will log their physical activity. Using the well known UK premise of ‘five a day’ for eating five pieces of fruit or vegetables, children are encouraged to complete and log in the diary five pieces of physical activity a day, thereby meeting the recommended target of 60 minutes. Additional sections highlight the benefits of exercise, a healthy diet and exercising with asthma. The diary is reviewed on a weekly basis and activity reinforced by verbal praise and stickers.

Step 2: Children will participate in a ‘fun circuit’ class held once a week for 4 weeks. The class, designed to maintain activity levels and motivate, comprises a circuit of two minute activity stations. Participants will record their scores after each activity station and a pedometer will be given as a motivational tool. Participants will continue to complete their diary.

Step 3: Comprises a short motivational interview including goal setting follow by a review session. Progress on these goals will be reviewed at 4 month follow up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Body mass index (BMI) and exercise self-efficacy at 12 month follow-up

Secondary outcome measures

1. Self-reported activity
2. Emotional and behavioural wellbeing
3. Lung function (peak flow)
4. Waist circumference

Measureed at 4 month and 12 month follow-up.

Overall trial start date

01/04/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 9 to 11 years with one, or more of the following risk factors;
1.1. Asthma
1.2. Low exercise self-efficacy
1.3. Teacher-rated build above the 75th centile
1.4. Teacher-rated concern about participation in physical activity

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600 children from 20 schools

Participant exclusion criteria

Children with high levels of customary activity (teacher and pupil rated) this will include overweight children with high levels of customary activity

Recruitment start date

01/04/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospital
Nottingham
NG72UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG72UH
United Kingdom
+44 (0)115 951 5151
cris.glazebrook@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk

Funders

Funder type

Government

Funder name

National Institute of Healthcare Research (NIHR) (UK)

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/22029547

Publication citations

  1. Protocol

    Glazebrook C, Batty MJ, Mullan N, Macdonald I, Nathan D, Sayal K, Smyth A, Yang M, Guo B, Hollis C, Evaluating the effectiveness of a schools-based programme to promote exercise self-efficacy in children and young people with risk factors for obesity: steps to active kids (STAK)., BMC Public Health, 2011, 11, 830, doi: 10.1186/1471-2458-11-830.

Additional files

Editorial Notes