Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/11/2013
Date assigned
17/02/2014
Last edited
21/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Project Spraoi, based in Cork, is of vital importance to Ireland, as there are currently no initiatives that target at the same time physical activity, healthy eating and sedentary time amongst schoolchildren. Over half of Irish primary school age children do not achieve the recommended level of 60 minutes of physical activity per day and only 18% (16% boys; 20% girls) report eating vegetables twice or more daily. Such behaviours are unlikely to change as these children mature and, consequently, will contribute to rising health costs. According to the Department of Health, obesity alone indirectly costs the nation €0.4 billion per year.
Project Spraoi is a 24 month whole-school health promotion intervention. It is derived from New Zealand’s ‘Project Energize’ and is adapted to an Irish setting. This study aims to determine whether Project Spraoi has had any positive impact on physical activity, nutritional knowledge/behaviours and long-term health parameters including body composition and blood pressure.

Who can participate
The project is designed for primary schools but also extends to children’s homes. Participants will be 5-6 year old and 10-11 year old children attending primary schools in Cork city and county.

What does the study involve?
The programme includes: (i) provision of staff into schools to structure activity programmes that are aligned with the curriculum; and (ii) seeking opportunities to enhance nutritional intake.
The participating schools will be randomly allocated to one of two groups: a ‘intervention’ group (trained ‘Energizers’ will work with teachers to implement physical activity and nutrition initiatives) or a ‘control’ group (schools continue their usual school curriculum).
Children are evaluated, which involves taking measures (blood pressure, heart rate, height, weight, waist circumference, body fat, physical activity and fitness) at the beginning of the study and two years later. Parents/guardians are also asked to give consent and complete a written questionnaire.

What are the possible benefits and risks of participating?
Benefits include improvements in physical activity levels, nutritional behaviours and markers of health in schoolchildren. There are no risks to participating.

Where is the study run from?
Cork Institute of Technology and schools in in Cork city and county (Ireland).

When is the study starting and how long is it expected to run for?
October 2013 to June 2016.

Who is funding the study?
Cork Institute of Technology (Ireland)

Who is the main contact?
Dr Tara Coppinger
tara.coppinger@cit.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tara Coppinger

ORCID ID

Contact details

Cork Institute of Technology
Dept of Sport
Leisure & Childhood studies
Rossa Ave
Bishopstown
Cork
NA
Ireland
tara.coppinger@cit.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Project Spraoi: a strategy to improve nutrition and physical activity in schoolchildren - a randomised controlled trial

Acronym

Study hypothesis

It is hypothesised that improvements in:
1. Fitness, physical activity, nutritional knowledge/behaviour
2. Key long-term health parameters including body mass and blood pressure
will be found in children attending intervention schools, compared to those attending control schools.

Ethics approval

The Cork Institute of Technology’s Ethics Committee, October 2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Health promotion intervention for children attending primary schools in Cork city and county

Intervention

Schools are randomised to two groups:
1. Intervention group: Trained “Energizers” work with intervention schools to support teachers implement physical activity and nutrition initiatives.
2. Control group: Control schools do not receive any input from ‘Energizers’ and continue their usual school curriculum.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Physical activity level and intensity will be measured via 7 day accelerometry (Actigraph)
2. Nutritional knowledge and behaviour will be measured via questionnaire

Outcomes will be measured at baseline and 24 months (+/- 1-2 month/s).

Secondary outcome measures

1. Height measured using a Seca 213, portable stadiometer (Seca, Birmingham, UK)
2. Weight measured using a portable Tanita WB-110MA electronic scale (Tanita Corporation, Japan)
3. Body composition (percentage body fat, total lean and fat mass) using the Impedimed DF50, bioimpedence monitor (Queensland, Australia)
4. Waist circumference anthropometric measuring tape
5. Blood pressure and pulse measured by Auto Blood Pressure Monitor T8, Omron Corporation, Tokyo, Japan
6. Aerobic fitness measured by a fitness test - 550 metre run
7. Household questionnaire will be completed by parent/guardian

Outcomes will be measured at baseline and 24 months (+/- 1-2 month/s). In addition, height and weight measures at 6, 12 and 18 months +/- 2 weeks will be taken amongst the youngest (5-6 years old at baseline) age group.

Overall trial start date

01/10/2013

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All school children aged 5-11 years, who provide written and informed consent and parental/guardian consent, who are attending participating school.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

342

Participant exclusion criteria

On ethical grounds, there will be no exclusion criteria for participants but potential confounders will be assessed when undertaking measurements, in direct consultation with class teachers/principals.

Recruitment start date

01/10/2013

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

Cork Institute of Technology
Cork
NA
Ireland

Sponsor information

Organisation

Cork Institute of Technology (Ireland)

Sponsor details

Rossa Ave
Bishopstown
Cork
N/A
Ireland
tara.coppinger@cit.ie

Sponsor type

University/education

Website

http://www.cit.ie

Funders

Funder type

University/education

Funder name

Cork Institute of Technology (Ireland)

Alternative name(s)

CIT

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Ireland

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

Publication citations

Additional files

Editorial Notes