A randomised controlled trial of the effectiveness of support from breastfeeding counsellors for women who want to breastfeed

ISRCTN	ISRCTN37327292
DOI	https://doi.org/10.1186/ISRCTN37327292
Protocol serial number	RDC00941
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jonathan Graffy
Scientific

Department of General Practice and Primary Care
Queen Mary and Westfield College
Mile End
London
E1 4NS
United Kingdom

Phone	+44 (0)20 7882 7702/7923 4122

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breastfeeding
Intervention	1. Support from a breastfeeding counsellor 2. Standard care
Intervention type	Other
Primary outcome measure(s)	Proportion of women breast-feeding to 4 months
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/1999

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	720
Key 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
Key exclusion criteria	1. No spoken English 2. Unsafe for a volunteer to visit the woman's home
Date of first enrolment	01/12/1997
Date of final enrolment	01/12/1999

Department of General Practice and Primary Care

London
E1 4NS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/01/2004		Yes	No