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 |
| Secondary identifying numbers | 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
Scientific
Centre for Rural Health
University of Aberdeen
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
| Phone | +44 (0)1463 667322 |
|---|---|
| p.hoddinott@abdn.ac.uk |
Study information
| Study design | Randomised controlled trial and qualitative case-studies |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 study start date | 01/10/2004 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 14 clusters of GP practices |
| 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
- Scotland
- United Kingdom
Study participating centre
Centre for Rural Health
Inverness
IV2 3BL
United Kingdom
IV2 3BL
United Kingdom
Sponsor information
University of Aberdeen (UK)
Not defined
Not defined
c/o Professor David J Godden
The Centre for Rural Health
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
| Phone | +44 (0)1463 667322 |
|---|---|
| d.godden@abdn.ac.uk | |
| Website | http://www.abdn.ac.uk/crh/ |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Scottish Executive Health Department, Chief Scientist Office (UK) (ref: CZH/4/156)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
