Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00941
Study information
Scientific title
Acronym
Study hypothesis
This proposal is for randomised controlled trial to test whether women who receive extra support from a breastfeeding counsellor breastfeed for longer than those who do not. Women having their first child or women who did not breastfeed their last child for more than six weeks will be randomly allocated to determine whether or not they receive additional support from a breastfeeding counsellor. The study will be performed in general practice and women will be recruited and followed up by members of their primary care team.
This project addresses the question of how we can help women who have difficulties with breastfeeding and improve breastfeeding rates nationally. It builds up on the applicants previous research and will be a value to many mothers. If this study shows that breastfeeding counsellors are effective, it would encourage more women to train as counsellors and suggest that the NHS should promote their work.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Breastfeeding
Intervention
1. Support from a breastfeeding counsellor
2. Standard care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Proportion of women breast-feeding to 4 months
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1997
Overall trial end date
01/12/1999
Reason abandoned
Eligibility
Participant inclusion criteria
Women attending for antenatal care between 28 and 36 weeks of pregnancy are asked to complete the initial questionnaire, to determine if they are eligible for inclusion. Mothers were eligible for inclusion if they were considering breast feeding, not having breast-fed a previous child for more than 6 weeks
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
32 practices, 720 women (added 07/01/10)
Participant exclusion criteria
1. No spoken English
2. Unsafe for a volunteer to visit the woman's home
Recruitment start date
01/12/1997
Recruitment end date
01/12/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Practice and Primary Care
London
E1 4NS
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 London (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
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14703543
Publication citations
-
Results
Graffy J, Taylor J, Williams A, Eldridge S, Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding., BMJ, 2004, 328, 7430, 26, doi: 10.1136/bmj.328.7430.26.