The BIG Trial
Breastfeeding in Groups (BIG) a project funded by the CSO
For further information about the BIG trial please contact:
Dr. Pat Hoddinott, Senior Clinical Research Fellow and GP, Public Health Nutrition Research Group, University of Aberdeen, Room 1.015, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD
Tel: 01224 553178 (Mon, Tues, Fri) Tel: 01261 812221 (Weds and Thurs)
Email: p.hoddinott@abdn.ac.uk
Publications
Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial. Pat Hoddinott, Jane Britten, Gordon J Prescott, David Tappin, Anne Ludbrook, David J Godden
Full text of this paper is now available on: http://www.bmj.com/cgi/content/full/338/jan30_1/a3026
Cite as: BMJ 2009;338:a3026
The two tables referred to in the paper can be accessed here
Background to the breastfeeding in groups (BIG) trial
Rationale for the breastfeeding in groups (BIG) randomised controlled trial
Scotland has amongst the lowest breastfeeding rates in the developed world, with only 44% of babies receiving any breast milk at 6 weeks in 2005 (Bolling et al., 2007). There is a particular need for interventions that address health inequalities in breastfeeding, as younger more disadvantaged women are less likely to breastfeed (Bolling et al. 2007). The UK National Institute of Clinical Effectiveness endorses the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI) ten steps to successful breastfeeding (World Health Organisation 2007) as a minimum standard for postnatal care (Demott et al. 2006). The tenth step is to foster the establishment of breastfeeding support groups and refer mothers to them at hospital discharge. A randomised controlled trial of the BFHI, without step ten, increased breastfeeding duration until 1 year in Belarus (Kramer et al. 2001). Some randomized controlled trials of lay supporters (Britton et al., 2007) and some professional education interventions in pregnancy (Gagnon et al., 2007) have included group settings, but evidence is limited and the effectiveness of providing health service breastfeeding groups is unknown
Health professional definitions:
Health visitors: have a remit to promote health for families, particularly with children aged 0–5, and are responsible for preventative action. They usually have individual caseloads, however, some work in teams.
Midwives: care for women throughout pregnancy, birth and for 28 days after a baby is orn and predominantly work in either hospital and/or community teams.
The policy context for the BIG trial
Box 1 describes the Government policies being implemented concurrently with the BIG trial which created a climate of uncertainty and change for front line staff. Implementation of the BIG trial policy depended on how localities responded to these new Government policies, how they allocated personnel resources, their decisions about specialist or generalist roles for health professionals and their relative focus on breastfeeding compared to other initiatives.
Box 1: Government polices impacting on the BIG trial Maternity Services (Scottish Executive 2001; Scottish Executive 2002): Centralisation of maternity services, different models of midwifery teamwork, shorter hospital stays, reduced general practitioner involvement. Primary Care (The Scottish Government 2004): Re-organisation from Local Health Care Co-Operatives to Community Health Partnerships, which involved boundary and work place changes for some. Health Visiting (Scottish Executive 2005; The Scottish Government 2007): Change from routine surveillance for all mothers and babies to targeting care to those with greatest need, risk assessment and child protection. More focus on public health role and health inequalities for whole population. Change from general practice attachment to corporate working and greater specialisation. Community nursing (Scottish Executive 2006; Department of Health2004): All staff had job evaluations according to a knowledge and skills framework with corresponding salary changes resulting in changes in staff employment. |
References
Bolling, K., Grant, K., Hamlyn, B., & Thornton, A. (2007). Infant feeding survey 2005. United Kingdom: The Information Centre, Government Statistical Service.
Britton, C., McCormick, F. M., Renfrew, M. J., Wade, A., & King, S. E. (2007). Support for breastfeeding mothers. Cochrane Database of Systematic Reviews, 3
Demott, K., Bick, D., Norman, R., Ritchie, G., Turnbull, N., Adams, C. et al. (2006). Routine postnatal care of women and their babies. London: The National Collaborating Centre for Primary Care and Royal College of General Practitioners.
Gagnon, A. J. (2007). Individual or group antenatal education for childbirth/parenthood. Cochrane Database of Systematic Reviews, 2
Kramer, M. S., Chalmers, B., Hodnett, E. D., Sevkovskaya, Z., Dzikovich, I., Shapiro, S. et al. (2001). Promotion of breastfeeding intervention trial (PROBIT): A randomized trial in the republic of belarus. JAMA, 285(4), 413-420.
Scottish Executive. (2006). Delivering care, enabling health. Harnessing the nursing, midwifery and allied health professions' contribution to implementing delivering for health in Scotland. Edinburgh: Scottish Executive.
Scottish Executive. (2005). Health for all children 4. Guidance on implementation in Scotland. http://www.scotland.gov.uk/Resource/Doc/37432/0011167.pdf
Scottish Executive. (2002). Expert group on acute maternity services. Edinburgh: Scottish Executive.
Scottish Executive. (2001). A framework for maternity services in Scotland. Edinburgh: Scottish Executive.
Scottish Executive. Report of the Review of Nursing in the Community in Scotland. (2006). Visible, accessible and integrated care. Edinburgh: Scottish Executive.
World Health Organisation. (2007). Baby-friendly hospital initiative., October 2007 from http://www.who.int/nutrition/topics/bfhi/en/
World Health Organisation. (2003). Global strategy for infant and young child feeding. www.who.int/nut/documents/gs_infant_feeding_text_eng.pdf
Table W3 Characteristics of locality representatives interviewed
Role, number and type of interview |
Trial involvement |
L1 |
L2 |
L3 |
L4 |
L5 |
L6 |
L7 |
Total of unique individuals |
Midwives 3 focus groups. 2 individual |
Involved in breastfeeding groups & antenatal breastfeeding education |
11 |
1 |
2 |
|
1 |
1 |
31 |
8 |
Involved in antenatal breastfeeding group education only |
|
|
|
3 |
|
|
|
3 |
|
Not involved in breastfeeding groups or antenatal breastfeeding education |
|
|
|
|
12 |
12 |
|
1 |
|
Health Visitors 8 focus groups, 13 individual and 8 pair |
Attended breastfeeding groups |
6 |
6 |
7 |
3 |
6 |
8 |
5 |
41 |
Health Visitors 6 individual |
Did not attend breastfeeding groups |
N/A |
1 |
N/A |
1 |
1 |
1 |
1 |
5 |
Volunteers 2 Focus groups 3 individual |
Attended breastfeeding groups |
N/A |
5 |
N/A |
1 |
13 |
13 |
4 |
11 |
Midwife Managers 4 telephone |
|
14 |
1 |
15 |
15 |
16 |
16 |
14 |
4 |
Primary Care Managers 7 telephone |
|
17 |
1 |
1 |
1 |
28,9 |
28,9 |
27 |
7 |
Women 25 individual |
20 attenders; 5 non attenders |
4
|
3
|
4
|
3
|
4 |
4 |
3
|
25
|
Number of locality representatives |
|
13 |
18 |
15 |
13 |
17 |
19 |
19 |
105 unique individuals. 114 representatives, 126 interviews* |
1,2 One midwife covered two localities. 3 One volunteer covered two localities. 4,5,6 One midwife manager covered two localities.7,8,9 One primary care manager covered two localities. * One health visitor interviewed four times; six interviewed three times; five interviewed twice.
References
Bolling, K., Grant, K., Hamlyn, B., & Thornton, A. (2007). Infant feeding survey 2005. United Kingdom: The Information Centre, Government Statistical Service.
Britton, C., McCormick, F. M., Renfrew, M. J., Wade, A., & King, S. E. (2007). Support for breastfeeding mothers. Cochrane Database of Systematic Reviews, 3
Demott, K., Bick, D., Norman, R., Ritchie, G., Turnbull, N., Adams, C. et al. (2006). Routine postnatal care of women and their babies. London: The National Collaborating Centre for Primary Care and Royal College of General Practitioners.
Gagnon, A. J. (2007). Individual or group antenatal education for childbirth/parenthood. Cochrane Database of Systematic Reviews, 2
Festinger, F. (1954). A theory of social comparison. Human Relat, 1, 117-140.
Hoddinott, P. (2008). Group based approaches to supporting breastfeeding in primary care. (Doctoral dissertation, University of Aberdeen)
Hoddinott, P., Chalmers, M., & Pill, R. (2006). One-to-one or group based peer support for breastfeeding? Women's perceptions of a breastfeeding peer coaching intervention. Birth, 33(2), 139-146.
Hoddinott, P., Lee, A. J., & Pill, R. (2006). Effectiveness of a breastfeeding peer coaching intervention in rural Scotland. Birth, 33(1), 27-36.
Hoddinott, P., Pill, R., & Chalmers, M. (2007). Health professionals, implementation and outcomes: Reflections on a complex intervention to improve breastfeeding rates in primary care. Family Practice, 24(1), 84-91.
Kramer, M. S., Chalmers, B., Hodnett, E. D., Sevkovskaya, Z., Dzikovich, I., Shapiro, S. et al. (2001). Promotion of breastfeeding intervention trial (PROBIT): A randomized trial in the republic of belarus. JAMA, 285(4), 413-420.
Raj, V. K., & Plichta, S. B. (1998). The role of social support in breastfeeding promotion: A literature review. Journal of Human Lactation, 14(1), 41-45.
Scottish Executive. (2006). Delivering care, enabling health. Harnessing the nursing, midwifery and allied health professions' contribution to implementing delivering for health in Scotland. Edinburgh: Scottish Executive.
Scottish Executive. (2005). Health for all children 4. Guidance on implementation in Scotland. http://www.scotland.gov.uk/Resource/Doc/37432/0011167.pdf
Scottish Executive. (2002). Expert group on acute maternity services. Edinburgh: Scottish Executive.
Scottish Executive. (2001). A framework for maternity services in Scotland. Edinburgh: Scottish Executive.
Scottish Executive. Report of the Review of Nursing in the Community in Scotland. (2006). Visible, accessible and integrated care. Edinburgh: Scottish Executive.
World Health Organisation. (2007). Baby-friendly hospital initiative., October 2007 from http://www.who.int/nutrition/topics/bfhi/en/
World Health Organisation. (2003). Global strategy for infant and young child feeding. www.who.int/nut/documents/gs_infant_feeding_text_eng.pdf
The Preliminary study: The Banff and Buchan Breastfeeding Coaching Project
A preliminary controlled intervention study of group and individual peer support using action research methods significantly increased breastfeeding rates at 2 weeks and informed the design of this trial (Hoddinott, Chalmers & Pill 2006; Hoddinott, Lee & Pill 2006). Qualitative data revealed that groups were more popular than one-to-one peer support, that the action research process might contribute to effectiveness and that inter- and intra-team health professional relationships were an important determinant of outcome (Hoddinott, Chalmers, & Pill 2006; Hoddinott, Pill, & Chalmers 2007). A fuller discussion of both the preliminary study and the BIG trial is available (Hoddinott 2008)
Hoddinott, P., Chalmers, M., & Pill, R. (2006). One-to-one or group based peer support for breastfeeding? Women's perceptions of a breastfeeding peer coaching intervention. Birth, 33(2), 139-146.
Hoddinott, P., Lee, A. J., & Pill, R. (2006). Effectiveness of a breastfeeding peer coaching intervention in rural Scotland. Birth, 33(1), 27-36.
Hoddinott, P., Pill, R., & Chalmers, M. (2007). Health professionals, implementation and outcomes: Reflections on a complex intervention to improve breastfeeding rates in primary care. Family Practice, 24(1), 84-91.
Hoddinott, P. (2008). Group based approaches to supporting breastfeeding in primary care. (Doctoral dissertation, University of Aberdeen)
Published abstracts for the preliminary study: Effectiveness of a Breastfeeding Peer Coaching Intervention in Rural Scotland Pat Hoddinott, Amanda J. Lee and Roisin Pill, BIRTH 33:1 March 2006, 27-36
http://www3.interscience.wiley.com/journal/118622068/abstract
Background: Breastfeeding initiation in Scotland in 2000 was 63 percent, compared with over 90 percent in Norway and Sweden. Although peer support is effective in improving exclusivity of breastfeeding in countries where over 80 percent of women initiate breastfeeding, the evidence for effectiveness in countries with lower initiation is uncertain. Our primary aim was to assess whether group-based and one-to-one peer breastfeeding coaching improves breastfeeding initiation and duration.
Methods: Action research methodology was used to conduct an intervention study in 4 geographical postcode areas in rural northeast Scotland. Infant feeding outcomes at birth and hospital discharge; at 1, 2, and 6 weeks; and at 4 and 8 months were collected for 598 of 626 women with live births during a 9-month baseline period and for 557 of 592 women with live births during a 9-month intervention period. Groups met in 5 locations, with 266 groups meeting in the period when intervention women were eligible to attend. Data on place of birth and length of postnatal hospital stay were also collected. Control data from 10 other Health Board areas in Scotland were compared. An intention-to participate survey about coaching participation was completed by 206 of 345 women initiating breastfeeding. Group attendance data were collected by means of 266 group diaries.
Results: There was a significant increase in any breastfeeding of 6.8 percent from 34.3 to 41.1 percent (95% CI 1.2, 12.4) in the study population at 2 weeks after birth compared with a decline in any breastfeeding in the rest of Scotland of 0.4 percent from 44 to 43.6 percent (95%CI _1.2, 0.4). Breastfeeding rates increased compared with baseline rates at all time points until 8 months. However, the effect was not uniform across the 4 postcode areas and was not related to level of deprivation. Little difference was seen in receipt of information and knowledge about the availability of coaching among areas. All breastfeeding groups were well attended, popular, and considered helpful by participants. A minority of women (n = 14/206) participated in formal one-to-one coaching. Women who received antenatal, birth, and postnatal care from community midwife led units were more likely to be breastfeeding at 2 weeks (p = 0.007) than women who received some or all care in district maternity units. Conclusions: Group-based and one-to-one peer coaching for pregnant women and breastfeeding mothers increased breastfeeding initiation and duration in an area with below average breastfeeding rates.
One-to-One or Group-Based Peer Support for Breastfeeding? Women's Perceptions of a Breastfeeding Peer Coaching Intervention
Pat Hoddinott, Maretta Chalmers and Roisin Pill,
BIRTH 33:2 June 2006, 139-146. http://www3.interscience.wiley.com/journal/118622093/abstract
Background: Studies reporting one-to-one peer support interventions have been successful in some countries with high breastfeeding initiation rates, but less so in Great Britain, where low uptake of peer support has occurred. We conducted a peer coaching intervention study in rural Scotland that improved breastfeeding initiation and duration. This study reports qualitative data about participants' perceptions of the coaching intervention. The aim was to investigate why group-based peer support was more popular than one-to-one peer support.
Methods: Qualitative data were collected and analyzed from an initial focus group; 21 semi-structured interviews; and 31 coaching group observations and respondents (n = 105/192) in response to an open question about reasons for not choosing a personal coach in a survey of breastfeeding experiences. We developed a coding frame, identified themes, and constructed charts for analysis and interpretation of data.
Results: Analysis revealed that groups were more popular because they normalized breastfeeding in a social environment with refreshments, which improved participants' sense of well-being. Groups provided flexibility, a sense of control, and a diversity of visual images and experiences, which assisted women to make feeding-related decisions for themselves, and they offered a safe place to rehearse and perform breastfeeding in front of others, in a culture where breastfeeding is seldom seen in public. Women often felt initial anxiety when attending a group for the first time, and they expressed doubt that one set of ''breastfeeding rules'' would suit everyone.
Conclusions: Pregnant women and breastfeeding mothers will voluntarily engage in an activity to support breastfeeding if there is a net interactional (verbal, visual, emotional and gustatory) gain and a minimum risk of a negative experience. One-to-one peer coaching was perceived as a greater risk to confidence and empowerment than group- based peer coaching.
Health professionals, implementation and outcomes: reflections on a complex intervention to improve breastfeeding rates in primary care Pat Hoddinott, Roisin Pill and Maretta Chalmers Family Practice 2007;24:84-91.
http://fampra.oxfordjournals.org/cgi/content/abstract/cml061v1
Objectives. To understand why a complex breastfeeding coaching intervention, which offered health professional-facilitated breastfeeding groups for pregnant and breastfeeding mothers and personal peer coaches, was more effective at improving breastfeeding rates in some areas than others.
Methods. This controlled intervention study was designed, implemented and evaluated using principles from action research methodology. We theoretically sampled 14 health professionals with varying levels of involvement and 12 consented to be interviewed. We analysed data from 266 group diaries kept by health professionals, 31 group observations, 10 audio-recorded steering group meetings and field notes. Women's perspectives were obtained by analysing qualitative data from one focus group, 21 semi-structured qualitative interviews and responses to open-survey questions.
Results. The intervention was more effective at improving breastfeeding rates in areas where health visitors and midwives were committed to working together to implement the intervention, where health professionals shared group facilitation and where inter- and intra-professional relationships were strong. The area where the intervention was ineffective had continuity of a single group facilitator with breastfeeding expertise and problematic relationships within and between midwife and health visitor teams. No one style of group suited all women. Some preferred hearing different views, others valued continuity of help from a facilitator with breastfeeding expertise.
Conclusions. We hypothesise that involving several local health professionals in implementing an intervention may be more effective than a breastfeeding expert approach. Inter- and intra-health professional relationships may be an important determinant of outcome in interventions that aim to influence population behaviours like breastfeeding.