Adherence to home fortification with micronutrient powders in Kenyan pre-school children: self-reporting and sachet counts compared to an electronic monitoring device

Abstract

Background: The efficacy of home fortification with iron-containing micronutrient powders varies between trials, perhaps in part due to population differences in adherence. We aimed to assess to what extent adherence measured by sachet count or self-reporting forms is in agreement with adherence measured by electronic device. In addition, we explored how each method of adherence assessment (electronic device, sachet count, self-reporting forms) is associated with haemoglobin concentration measured at the end of intervention; and to what extent baseline factors were associated with adherence as measured by electronic device.

Methods: Three hundred thirty-eight rural Kenyan children aged 12-36 months were randomly allocated to three treatment arms (home fortification with two different iron formulations or placebo). Home fortificants were administered daily by parents or guardians over a 30 day-intervention period. We assessed adherence using an electronic device that stores and provides information of the time and day of opening of the container that was used to store the fortificants sachets in each child's residence. In addition, we assessed adherence by self-reporting and sachet counts. We also measured haemoglobin concentration at the end of intervention.

Results: Adherence, defined as having received at least 24 sachets (≥ 80%), during the 30-day intervention period was attained by only 60.6% of children as assessed by the electronic device. The corresponding values were higher when adherence was assessed by self-report (83.9%; difference: 23.3%, 95% CI: 18.8% to 27.8%) or sachet count (86.3%; difference: 25.7%, 95% CI: 21.0% to 30.4%). Among children who received iron, each 10 openings of the electronic cap of the sachet storage container were associated with an increase in haemoglobin concentration at the end of intervention by 1.2 g/L (95% CI: 0.0 to 1.9 g/L). Adherence was associated with the age of the parent but not with intervention group; with age, sex or anthropometric indices of the child; or with age or sex of the parent or guardian.

Conclusions: The use of self -reporting and sachet count may lead to overestimates of adherence to home fortification.

Trial registration: The trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.

Keywords: Child; Food, fortified; Iron; Kenya; Patient compliance; Preschool; Self-report.

Fig. 1

Participant flow chart

Fig. 2

Adherence measurements as assed by self-reporting and sachet tools compared with MEMS device. Panel a Data were not available for 17 children because 15 self-reporting forms were either missing or not filled out and records of 2 MEMS devices missing because 1 device was damaged and another was not returned at end of 30 days after randomization. Panel b Data were not available for 15 children because 13 children lost or did not return empty sachets and 2 MEMS devices were unavailable. Not all data points in Panel a and Panel b are visible due to over-lapping of adherence counts. The red line indicates perfect agreement in adherence counts between pairs of assessment methods. For each panel, data points presented above the reference line indicate overestimation of adherence assessed by self-report or sachet count, respectively, as compared to adherence measured by MEMS, whereas data points presented below the reference line indicate underestimation of adherence measured by MEMS

Fig. 3

Age of parent or guardian at baseline as a predictor of adherence to daily home fortification