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
Secondary identifying numbers	RDC00941

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 11/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
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	Proportion of women breast-feeding to 4 months
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/1997
Completion date	01/12/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	32 practices, 720 women (added 07/01/10)
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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of General Practice and Primary Care

London
E1 4NS
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 London (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	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/01/2004		Yes	No