Objectives: We sought to understand the influence of recurrent assessments on the behaviour of children and caregivers in a 2-year study of an agricultural livelihood intervention.
Design: This study used qualitative exit interviews from caregivers in the control arm of a large, cluster-randomised control trial, Shamba Maisha.
Setting: The study was conducted in Western Kenya and involved 12 health facilities between 2016 and 2019.
Participants: Participants were 99 caregivers in the control arm who had a child that was 6-36 months in age at the start of the study.
Interventions: Intervention participants within Shamba Maisha received an irrigation pump, farming lessons and a microloan. Control participants received no intervention but were offered the intervention after completing the 2-year study.
Results: Despite receiving no formal benefits, control caregivers reported improved mental health and enhanced knowledge of their child's health compared with the beginning of the study and reported changes in the child's play and diet that they attributed to participation in study assessments. Caregivers in the control arm attributed their changed behaviour to recurrent questioning, instrumental support, interactions with study staff and increased health knowledge.
Conclusions: Recurrent assessments altered participant behaviour, which may have made inference of the intervention's impact more difficult. In designing future, such studies with intervention and control arms, a trade-off between the gains in statistical power provided by recurrent visits and the avoidance of alterations in participants' behaviour that could affect responses to assessments must be considered when deciding on the number of visits for assessment.
Trial Registration Numbers: NCT03170986; NCT02815579.
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http://dx.doi.org/10.1136/bmjopen-2023-077637 | DOI Listing |
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Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
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January 2025
Department of Anatomy and Cell Biology, College of Medicine, Chung-Ang University, Seoul, 06974, South Korea.
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