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| [ 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 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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 |
| 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 |
| 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 |
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