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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Scientific title	A randomised controlled trial of the effectiveness of an education package in reducing baby walker use
Study objectives	Is 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) studied	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
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 study start date	01/10/1999
Completion date	30/04/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	The study population will comprise all pregnant women (of at least 28 weeks gestation) registered with 34 participating practices.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1999
Date of final enrolment	30/04/2002

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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.