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
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
-
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.