Nutritional Supplementation for Children Recovering from Long-Term Diarrhea in Kenya: A Mixed-Methods Study on Caregiver Acceptability and Adherence

Abstract

ObjectivesThis study aimed to assess caregiver acceptability of and adherence to a nutritional supplement of lactoferrin and lysozyme administered to children recovering from long-term diarrhea sequelae in Kenya. DesignAn explanatory sequential mixed-methods sub-study nested within a 16-week double-blind randomized, placebo controlled trial. SettingHoma Bay, Kisii, and Migori Counties in Kenya. Participants A total of 519 caregiver-child dyads with complete follow-up data were included in this study. Children were aged 6-24 months, had received medical care for diarrhea and were ready for discharge, had a mid-upper arm circumference of <12.5cm at screening, and were no longer exclusively breastfeeding. InterventionDaily sachets of an investigational product (IP) mixed with rice powder and administered with porridge for 16 weeks. Caregivers received baseline training and met with the research team every two weeks. Main outcome measuresThis study had two primary outcome measures: 1) acceptability of the IP, measured as the median response to a 5-point Likert scale used in surveys and 2) adherence to the IP, measured as the number of sachets consumed per 14-day course, as verified by pictorial logs and returned sachet counts. ResultsAdherence was high across all time points (median 14 sachets per two-week course; 85%–97% adherence). A 1-unit increase in acceptability was associated with 34% higher odds of full adherence (OR: 1.34; 95% CI: 1.16 – 1.55; p < 0.01). Qualitative analysis revealed that family member support, home visits, and pictorial adherence logs facilitated adherence, while administration fatigue, stigma surrounding supplementation, and food insecurity resulting in supplement sharing served as barriers. ConclusionsWhile caregiver adherence and acceptability of the IP were high, addressing challenges such as stigma, administration fatigue, and resource limitations may strengthen future implementation efforts and promote sustained use. Trial Registration Number: NCT05519254, PACTR202108480098476