A randomised controlled trial to evaluate the clinical and cost effectiveness of breastfeeding peer support groups in improving breastfeeding initiation, duration and satisfaction

ISRCTN	ISRCTN44857041
DOI	https://doi.org/10.1186/ISRCTN44857041
Protocol serial number	CZH/4/156
Sponsor	University of Aberdeen (UK)
Funder	Scottish Executive Health Department, Chief Scientist Office (UK) (ref: CZH/4/156)

Submission date: 19/12/2006
Registration date: 21/02/2007
Last edited: 03/02/2009

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 Pat Hoddinott
Scientific

Centre for Rural Health
University of Aberdeen
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom

Phone	+44 (0)1463 667322
Email	p.hoddinott@abdn.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial and qualitative case-studies
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The BIG Trial
Study objectives	1. To compare clinical and cost effectiveness of a policy to provide breastfeeding support groups with usual care (internal control) and non-participating areas of Scotland (external control) 2. To compare before and after breastfeeding rates at six to eight weeks between intervention and control 3. To compare womens breastfeeding satisfaction between intervention and control 4. To measure the costs of the intervention to the health service and parents of each additional percentage point change in breastfeeding prevalence at six to eight weeks 5. To examine implementation processes using a qualitative case study approach
Ethics approval(s)	Metropolitan MREC approval gained on the 26th July 2004 (ref: 04/MRE11/28)
Health condition(s) or problem(s) studied	Breastfeeding
Intervention	14 clusters of GP practices will be randomised to intervention or control. Intervention areas will be asked to double their existing number of breastfeeding groups and set up a minimum of two new breastfeeding groups. Groups will: 1. Be for women and their children 2. Be held weekly 3. Invite pregnant women and breastfeeding mothers 4. Have a health professional group facilitator 5. Be woman-centred with at least 50% of time social and interactive. Area group facilitators will meet with women and voluntary organisation representatives every six to eight weeks for support and reflective practice. A group resource pack and a training day will be provided. Control areas will provide usual care with no new breastfeeding group activity.
Intervention type	Other
Primary outcome measure(s)	Any breastfeeding (exclusive or partial) at six to eight weeks for two years pre-study and two study years (National Child Health Surveillance Programme data).
Key secondary outcome measure(s)	1. Any breastfeeding at birth (National Child Health Surveillance Programme data). 2. Any breastfeeding at seven days (Guthrie data). 3. Any breastfeeding at eigh to nine months (National Child Health Surveillance Programme data). 4. Womens' satisfaction using the Maternal Breastfeeding Evaluation Scale. 5. Social support using The Duke-UNC Functional Social Support Questionnaire. 6. Knowledge of and attendance at any birth related groups. 7. Qualitative case studies to examine variations and implementation processes. 8. NHS costs and the costs and benefits to women.
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	14
Key inclusion criteria	1. Clusters of General Practitioner (GP) practices collecting National Child Health Surveillance Programme data 2. Any pregnant women or breastfeeding mothers with babies less than eight months old can participate in breastfeeding groups set up by intervention areas
Key exclusion criteria	1. Clusters of GP practices that do not collect National Child Health Surveillance Programme data 2. Any woman identified by health professionals as having a severe medical or mental health problem which could be detrimental to other group participants and/or their babies
Date of first enrolment	01/10/2004
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Centre for Rural Health

Inverness
IV2 3BL
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	recruitment results	01/05/2007		Yes	No
Results article	results	30/01/2009		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes