Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

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.