1Maya Health Alliance / Wuqu Kawoq, Guatemala, 2Academy of Nutrition and Dietetics, Chicago, USA, 3George Mason University, Washington, USA, 4Purdue University , Lafayette, USA.
Background and aims. Community-based research studies have been delayed or halted due to the on-going COVID-19 pandemic. However, delaying non-COVID-19 related nutrition research in vulnerable populations with a high prevalence of food insecurity and limited access to quality health services may have additional negative public health implications. The Saqmolo’ study is a community-based, randomized controlled trial (planned N=1200) that examines how adding one egg daily to standard nutrition care (i.e., education, growth monitoring, micronutrient powders) impacts child development in rural, Maya infants. We are discussing adaptations made to start the study safely due to the COVID-19 pandemic.
Methods. We adapted the study protocol based on Maya Health Alliance, institutional review board, and government COVID-19 safety guidelines. Main changes included. virtual training for the study staff; recruiting by phone versus in-person; assessing participants´ COVID-19 exposure before scheduling home visits; social distancing (1.5 m) during visits while using PPE; limiting time for home visits (45-60 min); and full adherence to a COVID-19 sanitation protocol.
Results. We will monitor the impact of these changes and the repercussions of the COVID-19 pandemic on study recruitment and retention efforts. We anticipate reduced flexibility to recruit in- person and inside health facilities, poorer baseline child nutritional status due to increased food insecurity, and in some cases, limited participant phone access, potentially impacting recruitment rates and generalizability. Supervisors will monitor COVID-19 related events and staff adherence to the COVID-19 safety protocols and provide additional support, as necessary.
Conclusion. Continuing to deliver nutrition interventions safely and effectively to at-risk populations during the on-going COVID-19 pandemic should be a priority. Preliminary experiences in identifying best practices for safely conducting community-based research can potentially be adapted for other studies/programs. Trial registration. NCT04316221
Keywords: COVID-19; randomized trial; food security.