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 |
| Protocol serial number | RBK99XX7 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- 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
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 |
| denise.kendrick@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The primary outcome measure is prevalence of baby walker possession and use. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
Division of General Practice
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
