An evaluation of community peer support workers within a programme to improve breastfeeding in Heart of Birmingham Primary Care Trust: a cluster randomised controlled trial

ISRCTN	ISRCTN16126175
DOI	https://doi.org/10.1186/ISRCTN16126175
Secondary identifying numbers	N/A

Submission date: 23/07/2007
Registration date: 11/01/2008
Last edited: 23/08/2011

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

Prof Christine MacArthur
Scientific

Department of Public Health and Epidemiology
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	c.macarthur@bham.ac.uk

Study information

Study design	Single-centre, cluster randomised controlled trial with general practice as the unit of randomistion. General practices were allocated by computer randomisation.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	HoBBIT - Heart of Birmingham Breastfeeding Initiation Trial
Study objectives	The primary research question is whether antenatal community breastfeeding peer support workers can increase breastfeeding initiation.
Ethics approval(s)	Sandwell and West Birmingham Ethics Committee, approved on 2nd February 2006 (ref: 05/Q2709/170)
Health condition(s) or problem(s) studied	Breastfeeding initiation and continuation
Intervention	The intervention is a community breastfeeding peer support service - trained Peer Support Workers (PSWs) will be available to provide breastfeeding information, advice, skills and support, offered to all women. They will make face-to-face contact with the women antenatally through the midwife at about 24-28 weeks in the antenatal clinic or at home. A minimum of two antenatal face-to-face contacts will be aimed for. The PSWs will continue to give support postnatally as required in order to increase continuation. The comparator is usual care.
Intervention type	Other
Primary outcome measure	Breastfeeding initiation rate, defined as the mother either puts the baby to the breast or the baby is given any of the mothers breast milk within the first 48 hours of delivery. Data will be obtained from routine maternity hospital records.
Secondary outcome measures	1. Breastfeeding continuation rate at 10-14 days and 6 weeks, with data obtained from routine Health Visitor records 2. Breastfeeding at 6 months, with data obtained from questionnaires to mothers who consent to be contacted at this time
Overall study start date	01/11/2006
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	3,000
Key inclusion criteria	All women booking for maternity care in all the practices within the Heart of Birmingham Primary Care Trust.
Key exclusion criteria	No exclusion criteria.
Date of first enrolment	01/11/2006
Date of final enrolment	30/04/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Public Health and Epidemiology

Birmingham
B15 2TT
United Kingdom

Sponsor information

Heart of Birmingham Primary Care Trust (UK)
Hospital/treatment centre

Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
England
United Kingdom

Funders

Funder type

Government

Heart of Birmingham Primary Care Trust (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	30/01/2009		Yes	No