Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trialBMJ 2009; 338 doi: http://dx.doi.org/10.1136/bmj.a3026 (Published 30 January 2009) Cite this as: BMJ 2009;338:a3026
- Pat Hoddinott, senior clinical research fellow1,
- Jane Britten, research fellow1,
- Gordon J Prescott, senior lecturer2,
- David Tappin, senior clinical lecturer3,
- Anne Ludbrook, professor4,
- David J Godden, director1
- 1Centre for Rural Health, University of Aberdeen, Centre for Health Science, Inverness IV2 3JH
- 2Department of Public Health, University of Aberdeen, Aberdeen AB25 2ZD
- 3Paediatric Epidemiology and Community Health Unit, Section of Child Health, University of Glasgow, Royal Hospital for Sick Children, Glasgow G3 8SJ
- 4Health Economics Research Unit, University of Aberdeen, Aberdeen
- Correspondence to: P Hoddinott
- Accepted 30 September 2008
Objective To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women.
Design Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes.
Setting Primary care in Scotland.
Participants Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that routinely collect breastfeeding outcome data.
Intervention Localities set up new breastfeeding groups to provide population coverage; control localities did not change group activity.
Main outcome measures Primary outcome: any breast feeding at 6-8 weeks from routinely collected data for two pre-trial years and two trial years. Secondary outcomes: any breast feeding at birth, 5-7 days, and 8-9 months; maternal satisfaction.
Results Between 1 February 2005 and 31 January 2007, 9747 birth records existed for intervention localities and 9111 for control localities. The number of breastfeeding groups increased from 10 to 27 in intervention localities, where 1310 women attended, and remained at 10 groups in control localities. No significant differences in breastfeeding outcomes were found. Any breast feeding at 6-8 weeks declined from 27% to 26% in intervention localities and increased from 29% to 30% in control localities (P=0.08, adjusted for pre-trial rate). Any breast feeding at 6-8 weeks increased from 38% to 39% in localities not participating in the trial. Women who attended breastfeeding groups were older (P<0.001) than women initiating breast feeding who did not attend and had higher income (P=0.02) than women in the control localities who attended postnatal groups. The locality cost was £13 400 (€14 410; $20 144) a year.
Conclusion A policy for providing breastfeeding groups in relatively deprived areas of Scotland did not improve breastfeeding rates at 6-8 weeks. The costs of running groups would be similar to the costs of visiting women at home.
Trial registration Current Controlled Trials ISRCTN44857041.
We thank all the managers, health professionals, volunteers, and women who participated in this trial and made it possible. We thank Lee Dowie for trial administration, Fiona Ryan for secretarial support, Roisin Pill (Cardiff University) for qualitative research consultancy, Marion Campbell (University of Aberdeen) for statistical consultancy, Mary Whitmore for training in group facilitation skills, and the Scottish National Neonatal Screening Laboratory, Yorkhill, Glasgow for providing breastfeeding data at 5-7 days gathered on Guthrie cards.
Contributors: PH had the idea for the study. PH, JB, DJG, AL, DT, J Mollison (University of Oxford), and R McInnes (University of Stirling) designed the study. PH and JB coordinated the trial. Quantitative data collection and intervention implementation were overseen by principal investigators (Anne Burns, David Cairns, Angie Docherty, Karen McVittie, Belinda Morgan, Diana Morgan, Marella O’Neill) and local investigators (Jacqueline Allison, Wilma Barnes, Karen Callery, Anne Docherty, Catriona Dreghorn, Gillian Graham, Gina Graham, Liz Greene, Janice Janeczko, Zea Kennedy, Catriona MacLean, Debby Millar, Rosemary Mould, Margaret Pieroni, Andrina Reid, Joan Syme, Ruth Walsh, Emily Whitelaw). All principal and local investigators were employed by NHS Scotland. AL collected and analysed health economic data, with assistance from L Ternent. PH and JB collected and analysed qualitative data. J Chalmers and C Nolan (Information and Statistics Division, Scottish Government) provided Child Health Surveillance Programme data. DT provided and managed Guthrie data. GJP led the statistical analyses. K Harrild and O Say helped with data management. PH is the guarantor.
Funding: The Chief Scientist’s Office of the Scottish Government Health Directorate provided funding through a research grant (CZH/4/156). PH was funded through a primary care research career award, and the Health Economics Research Unit, University of Aberdeen received core funding. The funding body had no role in the study design, data collection, analysis, or writing of reports; it received interim progress reports at six and 18 months and a final report after three years.
Competing interests: None declared.
Ethical approval: The Metropolitan Multi-centre Research Ethics Committee approved the study.
Provenance and peer review: Not commissioned; externally peer reviewed.
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