Contact information
Type
Scientific
Primary contact
Dr Pat Hoddinott
ORCID ID
Contact details
Centre for Rural Health
University of Aberdeen
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
+44 (0)1463 667322
p.hoddinott@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZH/4/156
Study information
Scientific title
Acronym
The BIG Trial
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 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
Metropolitan MREC approval gained on the 26th July 2004 (ref: 04/MRE11/28)
Study design
Randomised controlled trial and qualitative case-studies
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/10/2004
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
14 clusters of GP practices
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Rural Health
Inverness
IV2 3BL
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
c/o Professor David J Godden
The Centre for Rural Health
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
+44 (0)1463 667322
d.godden@abdn.ac.uk
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
Scottish Executive Health Department, Chief Scientist Office (UK) (ref: CZH/4/156)
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
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
Publication citations
-
Recruitment results
Hoddinott P, Britten J, Harrild K, Godden DJ, Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?, Contemp Clin Trials, 2007, 28, 3, 232-241, doi: 10.1016/j.cct.2006.08.004.
-
Results
Hoddinott P, Britten J, Prescott GJ, Tappin D, Ludbrook A, Godden DJ, Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial., BMJ, 2009, 338, a3026.