Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
10/08/2016
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 Peymane Adab

ORCID ID

Contact details

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 414 3777
p.adab@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4795

Study information

Scientific title

Preventing childhood obesity in the UK, with a focus on South Asian children (Birmingham healthy Eating and Active lifestyle for CHildren Study)

Acronym

BEACHeS

Study hypothesis

The aim is to develop an intervention programme for preventing obesity in children, which can later be evaluated in a definitive randomised controlled trial (RCT). The objectives for the study therefore include:
1. To apply an environmental analysis framework to prioritise components for the interventional package
2. To develop the components and time sequence of the intervention programme
3. To assess baseline physical activity (PA), diet and obesity measures in the populations under study
4. To implement an exploratory trial using the intervention, assess feasibility and acceptability
5. To pilot instruments (for obesity, dietary and physical-activity assessment) that will be used for outcome assessment in the definitive trial

Ethics approval

MREC approved (ref: 06/Q2703/43)

Study design

Multicentre non-randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Paediatrics

Intervention

Interventional schools: Increase children's physical activity levels through schools, including physical activity, cooking and skills for families (through cooking skills workshops, signposting of local leisure facilities and organised taster sessions, and setting up walking teams)
Control schools: No active intervention

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

Feasibility and acceptability of intervention

Secondary outcome measures

Direction of effect for change in measures of obesity, physical activity and diet

Overall trial start date

13/11/2006

Overall trial end date

05/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 5 - 7 at baseline, either sex
2. Attending one of the selected schools

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 600; UK sample size: 600

Participant exclusion criteria

Parents do not give active consent

Recruitment start date

13/11/2006

Recruitment end date

05/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

University Hospitals Birmingham
Methley Lane
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: 75374)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26861933

Publication citations

Additional files

Editorial Notes

10/08/2016: Publication reference added.