Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/08/2012
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

Dr Mary Rudolf

ORCID ID

Contact details

Department of Community Paediatrics
Belmont House
3/5 Belmont Grove
Leeds
LS2 9NP
United Kingdom
+44 (0)113 292 6352
Mary.Rudolf@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCC112 RUDOLF R&D

Study information

Scientific title

Acronym

APPLES

Study hypothesis

Obesity is a major public health problem affecting some 15% of the adult population, causing significant morbidity. As such, it forms one of the Health of the Nation targets. Control of obesity, once established is notoriously difficult to achieve, and preventative measures are therefore required. The proposed study has been designed to determine whether a Primary School based health education programme can influence life style factors (namely nutrition and exercise) and so affect the development of obesity.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Other nutritional, metabolic and endocrine disease

Intervention

1. Primary School based health education programme
2. No programme

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

If successful, an improvement in quality of diet and levels of exercise will be achieved in children of all weights, along with a reduction in the number of children in the overweight category. The principal benefit to the NHS will be the development of a novel approach to the problem of obesity for an age group where it is most likely to have an effect. Other benefits include the adoption of Health Promoting School principles in additional schools in Leeds, validation of the new BMI charts in childhood, and critical trial of health education curriculum materials.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/01/1996

Overall trial end date

31/05/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Children attending primary schools in Leeds

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

06/01/1996

Recruitment end date

31/05/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Community Paediatrics
Leeds
LS2 9NP
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11691759

Publication citations

  1. Results

    Sahota P, Rudolf MC, Dixey R, Hill AJ, Barth JH, Cade J, Randomised controlled trial of primary school based intervention to reduce risk factors for obesity., BMJ, 2001, 323, 7320, 1029-1032.

Additional files

Editorial Notes