Effect of a participatory intervention in women’s self-help groups for the prevention of chronic suppurative otitis media in their children in Jumla Nepal: a cluster-randomised trial

Chronic suppurative otitis media (CSOM) causes preventable deafness and disproportionately affects children living in poverty. Our hypothesis was that health promotion in women’s groups would increase their knowledge, attitudes and practices (KAP) regarding ear disease and reduce the prevalence of CSOM in their children. We did a cluster randomised trial in two village development committees (VDCs) in Jumla, Nepal. In July 2014, 30 women’s groups were randomly allocated to intervention or control, stratified by VDC and distance to the road. The intervention groups participated in three sessions of health promotion using the WHO Hearing and Ear Care Training Resource Basic Level. The primary outcome was women’s KAP score and the secondary outcome was prevalence of CSOM in their children at 12 month follow-up. Analyses were by intention to treat. Participants and the research team were not masked to allocation. In June and July 2014 we recruited 508 women and 937 of their children. 12 months later there was no difference in the women’s KAP score (mean difference 0.14, 95% CI − 0.1 to 0.38, P = 0.25) or the prevalence of CSOM in their children (OR 1.10, 95%CI 0.62 to 1.84, P = 0.75) between intervention and control groups. However, overall, there was a significant improvement in the KAP score (mean difference − 0.51, 95% CI − 0.71,to − 0.31, P < 0.0001) and in the prevalence of CSOM from baseline 11.2% to follow-up 7.1% (P < 0.0001). Health promotion in women’s groups did not improve maternal KAP or reduce prevalence of CSOM. Over time there was a significant improvement in women’s KAP score and reduction in the prevalence of CSOM which may be attributable to our presence in the community offering treatment to affected children, talking to their parents and providing ciprofloxacin drops to the local health posts. More research is needed in low resource settings to test our findings. Australia and New Zealand Clinical Trial Registry 12,614,000,231,640 ; Date of registration: 5.3.2014: Prospectively registered.