Condition category
Pregnancy and Childbirth
Date applied
23/07/2007
Date assigned
11/01/2008
Last edited
23/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christine MacArthur

ORCID ID

Contact details

Department of Public Health and Epidemiology
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
c.macarthur@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HoBBIT - Heart of Birmingham Breastfeeding Initiation Trial

Study hypothesis

The primary research question is whether antenatal community breastfeeding peer support workers can increase breastfeeding initiation.

Ethics approval

Sandwell and West Birmingham Ethics Committee, approved on 2nd February 2006 (ref: 05/Q2709/170)

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

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Breastfeeding initiation rate, defined as the mother either puts the baby to the breast or the baby is given any of the mother’s 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 trial start date

01/11/2006

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All women booking for maternity care in all the practices within the Heart of Birmingham Primary Care Trust.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3,000

Participant exclusion criteria

No exclusion criteria.

Recruitment start date

01/11/2006

Recruitment end date

30/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Heart of Birmingham Primary Care Trust (UK)

Sponsor details

Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Heart of Birmingham Primary Care Trust (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19181730

Publication citations

  1. Results

    MacArthur C, Jolly K, Ingram L, Freemantle N, Dennis CL, Hamburger R, Brown J, Chambers J, Khan K, Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial., BMJ, 2009, 338, b131.

Additional files

Editorial Notes