Contact information
Type
Scientific
Primary contact
Dr Denise Kendrick
ORCID ID
http://orcid.org/0000-0003-3603-6542
Contact details
Division of General Practice
University of Nottingham
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 970 9389
denise.kendrick@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBK99XX7
Study information
Scientific title
A randomised controlled trial of the effectiveness of an education package in reducing baby walker use
Acronym
Study hypothesis
Is an education package delivered by midwives and health visitors aimed at reducing baby walker use effective?
Ethics approval
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Pediatric injury
Intervention
i. 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome measure is prevalence of baby walker possession and use.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1999
Overall trial end date
30/04/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study population will comprise all pregnant women (of at least 28 weeks gestation) registered with 34 participating practices.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1999
Recruitment end date
30/04/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of General Practice
Nottingham
NG7 2UH
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 Trent (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
Basic results (scientific)
Publication list
1. 2003 results in: https://www.ncbi.nlm.nih.gov/pubmed/12634038
2. 2003 results in: https://doi.org/10.1177/001789690306200105
3. 2003 results in: https://www.ncbi.nlm.nih.gov/pubmed/12919267
4. 2003 results in: https://doi.org/10.1177/001789690306200407
5. 2005 results in: https://www.ncbi.nlm.nih.gov/pubmed/16105365
6. 2006 results in: http://hej.sagepub.com/content/65/3/197.abstract
7. 2018 results in: http://dx.doi.org/10.1136/bmjopen-2017-020056