A randomised controlled trial of the effectiveness of an education package in reducing baby walker use

ISRCTN ISRCTN54817783
DOI https://doi.org/10.1186/ISRCTN54817783
Secondary identifying numbers RBK99XX7
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
06/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Denise Kendrick
Scientific

Division of General Practice
University of Nottingham
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

ORCiD logoORCID ID 0000-0003-3603-6542
Phone +44 (0)115 970 9389
Email denise.kendrick@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Scientific titleA randomised controlled trial of the effectiveness of an education package in reducing baby walker use
Study objectivesIs an education package delivered by midwives and health visitors aimed at reducing baby walker use effective?
Ethics approval(s)Ethical approval as of 06/02/2019:
Queen's Medical Centre, University Hospital NHS Trust Ethics Committee, 13/07/1999, ref. EX029902.
North Nottinghamshire Local Research Ethics Committee, 12/06/2000, ref. NNHA/494.

Previous ethical approval:
Queen's Medical Centre, Nottingham, ref. EX029902.
Health condition(s) or problem(s) studiedPediatric injury
Interventioni. Evidence based educational package developed to reduce baby walker use. The package will be presented at one ante-natal consultation from 28 weeks (by midwives) and in 2 post-natal consultations, at the birth review and 3-4 month hip check (by health visitors).
ii. No exposure to package.
Intervention typeOther
Primary outcome measureThe primary outcome measure is prevalence of baby walker possession and use.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/1999
Completion date30/04/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaThe study population will comprise all pregnant women (of at least 28 weeks gestation) registered with 34 participating practices.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/1999
Date of final enrolment30/04/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of General Practice
Nottingham
NG7 2UH
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2003 Yes No
Results article results 01/03/2003 Yes No
Results article results 01/09/2003 Yes No
Results article results 01/12/2003 Yes No
Results article results 01/08/2005 Yes No
Results article results 01/09/2006 Yes No
Results article results 01/06/2018 Yes No

Editorial Notes

06/02/2019: The ethics approval was updated.
31/01/2019: The following changes were made:
1. The ORCID was added.
2. The ethics was added.
3. Publication references added.