ISRCTN ISRCTN61188203
DOI https://doi.org/10.1186/ISRCTN61188203
Protocol serial number PCC112 RUDOLF R&D
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Northern and Yorkshire (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
01/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary Rudolf
Scientific

Department of Community Paediatrics
Belmont House
3/5 Belmont Grove
Leeds
LS2 9NP
United Kingdom

Phone +44 (0)113 292 6352
Email Mary.Rudolf@leedsth.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymAPPLES
Study objectivesObesity 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOther nutritional, metabolic and endocrine disease
Intervention1. Primary School based health education programme
2. No programme
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/1999

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Key inclusion criteriaChildren attending primary schools in Leeds
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment06/01/1996
Date of final enrolment31/05/1999

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Community Paediatrics
Leeds
LS2 9NP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/11/2001 Yes No