Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial.

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.

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 pound13 400 (euro14 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.