Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial

Background Community-based management of severe acute malnutrition (SAM) involves weekly or biweekly outpatient clinic visits for clinical surveillance and distribution of therapeutic foods. Distance to outpatient clinics and high opportunity costs for caregivers can represent major barriers to access. Reducing the frequency of outpatient visits while providing training to caregivers to recognize clinical danger signs at home between outpatient visits may increase acceptability, coverage, and public health impact of SAM treatment. We investigated the effectiveness of monthly clinic visits compared to the standard weekly follow-up in the outpatient treatment of uncomplicated SAM in northwestern Nigeria. Methods and findings We conducted a cluster randomized crossover trial to test the noninferiority of nutritional recovery in children with uncomplicated SAM receiving monthly follow-up compared to the standard weekly schedule. From January 2018 to November 2019, 3,945 children aged 6 to 59 months were enrolled at 10 health centers (5 assigned to monthly follow-up and 5 assigned to weekly follow-up) in Sokoto, Nigeria. In total, 96% of children (n = 1,976 in the monthly follow-up group and 1,802 in the weekly follow-up group) were followed until program discharge, and 91% (n = 1,873 in the monthly follow-up group and 1,721 in the weekly follow-up group) were followed to 3 months postdischarge. The mean age at admission was 15.8 months (standard deviation [SD] 7.1), 2,097/3,945 (53.2%) were girls, and the mean midupper arm circumference (MUAC) at admission was 105.8 mm (SD 6.0). In a modified intention-to-treat analysis, the primary outcome of nutritional recovery, defined as having MUAC ≥125 mm on 2 consecutive visits, was analyzed using generalized linear models, with generalized estimating equations to account for clustering. Nutritional recovery was lower in the monthly follow-up group compared to the weekly group (1,036/1,976, 52.4% versus 1,059/1,802, 58.8%; risk difference: −6.8%), and noninferiority was not demonstrated (lower bound of the confidence interval [CI] was −11.5%, lower than the noninferiority margin of 10%). The proportion of children defaulting was lower in the monthly group than in the weekly group (109/1,976, 5.5% versus 151/1,802, 8.4%, p = 0.03). Three months postdischarge, children in the monthly group were less likely to relapse compared to those in the weekly group (58/976, 5.9% versus 78/1,005, 7.8%, p = 0.03), but cumulative mortality at 3 months postdischarge was higher in the monthly group (159/1,873, 8.5% versus 106/1,721, 6.2%, p < 0.001). Study results may depend on context-specific factors including baseline level of care and the clinical status of children presenting to health centers, and, thus, generalizability of these results may be limited. Conclusions Where feasible, a weekly schedule of clinic visits should be preferred to maintain effectiveness of SAM treatment. Where geographic coverage of programs is low or frequent travel to outpatient clinics is difficult or impossible, a monthly schedule of visits may provide an alternative model to deliver treatment to those in need. Modifications to the outpatient follow-up schedule, for example, weekly clinic visits until initial weight gain has been achieved followed by monthly visits, could increase the effectiveness of the model and add flexibility for program delivery. Trial registration ClinicalTrials.gov NCT03140904. Matt D.T. Hitchings and colleagues investigate the effectiveness of a monthly schedule of follow-up for the management of uncomplicated severe acute malnutrition in children aged 6-59 months in Nigeria. Author summary Why was this study done? Severe acute malnutrition (SAM) affects at least 13.6 million children under 5 worldwide each year and is associated with significant increase in mortality and morbidity. Despite improvements in the management of SAM, coverage of treatment programs remains low. Distance to outpatient clinics and high opportunity costs for caregivers represent major barriers to access. New models are needed to increase coverage and access to lifesaving treatment for SAM. What did the researchers do and find? We conducted a cluster randomized crossover trial to assess the effectiveness of a monthly follow-up schedule compared to a weekly schedule in terms of nutritional recovery and secondary outcomes including nonresponse, default, hospitalization, and death, and weight gain, length of stay, and relapse among recovered children. Study outcomes were assessed at the end of treatment and at 3 months postdischarge. Noninferiority of the monthly follow-up group in terms of nutritional recovery was not demonstrated. However, we found lower rates of default with monthly follow-up implying greater acceptability among caregivers. There was no statistical difference in weight velocity between groups at 4 and 8 weeks, but time to recovery was longer with monthly follow-up and relapse at 3 months postdischarge was less likely to occur in the monthly group. Finally, the mortality risk between admission and 3 months postdischarge was significantly higher in the monthly follow-up group. What do these findings mean? Where possible, a weekly schedule of clinic visits should be preferred for treatment of SAM. Although this study did not demonstrate noninferiority of a monthly schedule of follow-up for nutritional recovery, monthly follow-up may be considered in specific settings where more frequent follow-up is infeasible.