Impact on child acute malnutrition of integrating small-quantity lipid-based nutrient supplements into community-level screening for acute malnutrition: A cluster-randomized controlled trial in Mali

Lieven Huybregts, Agnes Le Port, Elodie Becquey, Amanda Zongrone, Francisco M Barba, Rahul Rawat, Jef L Leroy, Marie T Ruel, Lieven Huybregts, Agnes Le Port, Elodie Becquey, Amanda Zongrone, Francisco M Barba, Rahul Rawat, Jef L Leroy, Marie T Ruel

Abstract

Background: Community-based management of acute malnutrition (CMAM) has been widely adopted to treat childhood acute malnutrition (AM), but its effectiveness in program settings is often limited by implementation constraints, low screening coverage, and poor treatment uptake and adherence. This study addresses the problem of low screening coverage by testing the impact of distributing small-quantity lipid-based nutrient supplements (SQ-LNSs) at monthly screenings held by community health volunteers (CHVs). Screening sessions included behavior change communication (BCC) on nutrition, health, and hygiene practices (both study arms) and SQ-LNSs (one study arm). Impact was assessed on AM screening and treatment coverage and on AM incidence and prevalence.

Methods and findings: A two-arm cluster-randomized controlled trial in 48 health center catchment areas in the Bla and San health districts in Mali was conducted from February 2015 to April 2017. In both arms, CHVs led monthly AM screenings in children 6-23 months of age and provided BCC to caregivers. The intervention arm also received a monthly supply of SQ-LNSs to stimulate caregivers' participation and supplement children's diet. We used two study designs: i) a repeated cross-sectional study (n = approximately 2,300) with baseline and endline surveys to examine impacts on AM screening and treatment coverage and prevalence (primary study outcomes) and ii) a longitudinal study of children enrolled at 6 months of age (n = 1,132) and followed monthly for 18 months to assess impact on AM screening and treatment coverage and incidence (primary study outcomes). All analyses were done by intent to treat. The intervention significantly increased AM screening coverage (cross-sectional study: +40 percentage points [pp], 95% confidence interval [CI]: 32, 49, p < 0.001; longitudinal study: +28 pp, 95% CI: 23, 33, p < 0.001). No impact on treatment coverage or AM prevalence was found. Children in the intervention arm, however, were 29% (95% CI: 8, 46; p = 0.017) less likely to develop a first AM episode (incidence) and, compared to children in comparison arm, their overall risk of AM (longitudinal prevalence) was 30% (95% CI: 12, 44; p = 0.002) lower. The intervention lowered CMAM enrollment by 10 pp (95% CI: 1.9, 18; p = 0.016), an unintended negative impact likely due to CHVs handing out preventive SQ-LNSs to caregivers of AM children instead of referring them to the CMAM program. Study limitations were i) the referral of AM cases by our research team (for ethical reasons) during monthly measurements in the longitudinal study might have interfered with usual CMAM activities and ii) the outcomes presented by child age also reflect seasonal variations because of the closed cohort design.

Conclusions: Incorporating SQ-LNSs into monthly community-level AM screenings and BCC sessions was highly effective at improving screening coverage and reducing AM incidence, but it did not improve AM prevalence or treatment coverage. Future evaluation and implementation research on CMAM should carefully assess and tackle the remaining barriers that prevent AM cases from being correctly diagnosed, referred, and adequately treated.

Trial registration: ClinicalTrials.gov NCT02323815.

Conflict of interest statement

All authors have declared that no competing interests exist.

Figures

Fig 1. Theory of change of the…
Fig 1. Theory of change of the PROMIS intervention.
Hypothesized impacts of the intervention presented in this paper are shown in blue. The blue box represents the intervention. AM, acute malnutrition; IYCF, infant and young child feeding; PROMIS, Innovative Approaches for the Prevention of Childhood Malnutrition; SQ-LNS, small-quantity lipid-based nutrient supplement.
Fig 2. Trial profile for repeated cross-sectional…
Fig 2. Trial profile for repeated cross-sectional study and longitudinal study.
HC, health center.
Fig 3. Total SQ-LNS coverage and SQ-LNS…
Fig 3. Total SQ-LNS coverage and SQ-LNS coverage through the meeting with CHVs in the longitudinal study by child age and by study arm.
Line graphs represent the fitted values of the proportion of children who received SQ-LNS in the intervention arm (blue) and the comparison arm (orange) through the monthly meeting with CHV (dashed lines) or from any source (solid line). Gray areas represent 95% confidence bands of kernel-weighted local polynomial smoothed values by study arm using the observed data. Analysis is based on n = 9,424 child visits in the comparison arm and n = 9,434 in the intervention arm. Mixed-effects regression models with restricted cubic splines (knots at 9, 15, and 22 months of child age) were used with health center catchment area and child as random intercepts and health district, sampling strata, month of inclusion, child sex, whether the child was a first live birth or not, age splines, and intervention as fixed effects. A chunk Wald test was used to test the “age spline × intervention” interaction terms (p-values shown). CHV, community health volunteer; SQ-LNS, small-quantity lipid-based nutrient supplement.
Fig 4. Kaplan–Meier failure plot showing the…
Fig 4. Kaplan–Meier failure plot showing the cumulative probability of child AM by study arm using the longitudinal study data (n = 567 children in the comparison arm contributing 535 child-years of follow-up; n = 565 in the intervention arm contributing 604 child-years of follow-up).
The blue dashed line represents results from the intervention arm, and the orange solid line represents results from the comparison arm. AM, acute malnutrition.
Fig 5. Effect modification of the intervention…
Fig 5. Effect modification of the intervention by child age on AM prevalence during follow-up of children enrolled in the longitudinal study (n = 10,282 child visits in the comparison arm and n = 10,236 in the intervention arm).
The blue dashed line represents fitted values obtained from the regression model for the intervention arm. The orange solid line represents fitted values obtained from the same regression model but for the comparison arm. Gray areas represent 95% confidence bands of kernel-weighted local polynomial smoothed values by study arm using the observed data. Mixed-effects regression models with restricted cubic splines (knots at 9, 12, and 16 months of child age) were used with health center catchment area and child as random intercepts and health district, sampling strata, month of inclusion, child sex, whether the child was a first live birth or not, age splines, and intervention as fixed effects. A chunk Wald test was used to test the “age spline × intervention” interaction terms (p-value shown). AM, acute malnutrition.

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