Welcome
Support Centre
18 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN44857041
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to evaluate the clinical and cost effectiveness of breastfeeding peer support groups in improving breastfeeding initiation, duration and satisfaction
Scientific title
Acronym The BIG Trial
Serial number at source CZH/4/156
Study hypothesis 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 women’s 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
Lay summary
Ethics approval Metropolitan MREC approval gained on the 26th July 2004 (ref: 04/MRE11/28)
Study design Randomised controlled trial and qualitative case-studies
Countries of recruitment United Kingdom
Disease/condition/study domain Breastfeeding
Participants - 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
Participants - 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
Anticipated start date 01/10/2004
Anticipated end date 30/09/2007
Status of trial Completed
Patient information material
Target number of participants 14 clusters of GP practices
Interventions 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.
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).
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.
Sources of funding Scottish Executive Health Department, Chief Scientist Office (UK) (ref: CZH/4/156)
Trial website http://www.abdn.ac.uk/BIG/
Publications 1. 2007 recruitment results in http://www.ncbi.nlm.nih.gov/pubmed/16996320
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19181729
Contact name Dr  Pat  Hoddinott
  Address Centre for Rural Health
University of Aberdeen
The Green House
Beechwood Business Park
  City/town Inverness
  Zip/Postcode IV2 3BL
  Country United Kingdom
  Tel +44 (0)1463 667322
  Fax +44 (0)1463 667310
  Email p.hoddinott@abdn.ac.uk
Sponsor University of Aberdeen (UK)
  Address c/o Professor David J Godden
The Centre for Rural Health
The Green House
Beechwood Business Park
  City/town Inverness
  Zip/Postcode IV2 3BL
  Country United Kingdom
  Tel +44 (0)1463 667322
  Fax +44 (0)1463 667310
  Email d.godden@abdn.ac.uk
  Sponsor website: http://www.abdn.ac.uk/crh/
Date applied 19/12/2006
Last edited 03/02/2009
Date ISRCTN assigned 21/02/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.