Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial

Background Breastfeeding is crucial for a child’s health, providing numerous benefits such as improved disease resistance and intelligence. Despite global efforts, exclusive breastfeeding rates remain a concern. Maternal employment is a well-documented, significant barrier, as working mothers often face challenges in sustaining exclusive breastfeeding. Studies have shown that prenatal intention strongly influences breastfeeding practices. Thus, an intervention module in improving exclusive breastfeeding intention targeting knowledge, attitude, subjective norm, and perceived control is necessary. This study aims to develop, validate, and evaluate a theory-based intervention programme to improve exclusive breastfeeding intention among working mothers in Malacca, Malaysia. This randomised controlled trial, guided by CONSORT, will assess the intervention's impact on knowledge, attitude, subjective norm, perceived control, and exclusive breastfeeding intention among working mothers. Methods This two-arm randomised controlled trial will allocate pregnant women to either the intervention or control group by cluster, with each cluster defined as a government health clinic. This study will be conducted over a 30-month period, encompassing planning, theory-based module development, implementation, and effectiveness evaluation. All pregnant women who meet the inclusion criteria will be included. A total of 216 participants are needed for hypothesis testing. Participants will be randomly allocated into two parallel groups at a 1:1 ratio (n=108 per group) to receive either the health education intervention or standard routine care. The primary outcome is exclusive breastfeeding intention, and the secondary outcomes are knowledge, attitude, subjective norms, and perceived behaviour control regarding exclusive breastfeeding, which will be measured at baseline, 1 month, and 4 months postnatal. Discussion This study is the first trial to assess the effectiveness of a theory-based health education intervention in improving exclusive breastfeeding intention among working mothers in Malaysia. Furthermore, this study will provide evidence on the effectiveness of the intervention delivered throughout both the antenatal and postnatal periods within this region. Ethics and dissemination This study protocol was approved by the Medical Research and Ethics Committee Ministry of Health Malaysia (NMRR ID-24-02852-NQU (IIR) on 23 ^rd December 2024. Trial registration Thai Clinical Trials Registry, TCTR20250116001. Registered on 16 ^th January, 2025.