Nutritional treatment of children 6-59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial.

BACKGROUND: Admission criteria that treat children with low mid-upper-arm circumference (MUAC), and low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol. METHODS: This is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ <-3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥-3 for 2 visits, (3) standard treatment receiving RUTF according to WHZ category: (a) WHZ <-3 receive 200 kcal/kg/day until WHZ ≥-2 for 2 visits, (b) WHZ ≥-3 but <-2 receive 1 sachet daily until WHZ ≥-2 for 2 visits or (c) WHZ ≥-2 receive no treatment. All children will be followed up first fortnightly for 12 weeks and then monthly until 6 months post-enrolment. The primary endpoint will be measured at 2 months with the primary outcome being WAZ as a continuous measure. Other outcomes include other anthropometric measurements and a secondary endpoint will be observed at 6 months. A total of 1397 children will be recruited including 209 in the control and 594 in both the simplified and standard arms. The sample size should enable us to conclude on the superiority of the simplified treatment compared to no treatment and on the non-inferiority of the simplified treatment versus standard treatment with a margin of non-inferiority of 0.2 WAZ. DISCUSSION: This trial aims to generate new evidence on the benefit of treating children with WAZ <-3 but MUAC ≥125 mm in order to guide the choice of admission criteria to malnutrition treatment and build evidence on the most efficient treatment protocol. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov: NCT05248516 on February 21, 2022.

Intensified Nutrition Interventions in Antenatal Care Services Increased Consumption of Iron and Folic Acid Supplements and Early Breastfeeding Practices in Burkina Faso: Results of a Cluster-Randomized Program Evaluation.

BACKGROUND: Alive & Thrive supported the Government of Burkina Faso to strengthen the provision of iron and folic acid (IFA) supplementation and interpersonal counseling on maternal nutrition and breastfeeding through antenatal care (ANC) services and community-based contacts in 2 regions. OBJECTIVES: We assessed the impacts of intensified nutrition interventions during ANC compared with standard ANC services on intervention coverage and maternal nutrition practices. METHODS: A cluster-randomized evaluation compared 40 health center catchment areas in intervention areas with 40 in control areas. Repeated cross-sectional surveys in 2019 and 2021 (960 pregnant women and 1920 women with children 0-5 mo of age per survey round) provided data on impact indicators, intervention exposure, and other factors. We derived difference-in-difference (DID) effect estimates, adjusted for geographic clustering, for maternal dietary diversity, IFA consumption, and early breastfeeding practices. RESULTS: More women in intervention areas had 4+ ANC visits (DID: 8.3 percentage points [pps]) and started ANC during the first trimester (DID: 10.5 pp), compared with control areas. Improvements were achieved in exposure to nutrition counseling on dietary diversity (DID: 44.4 pp), food quantity (DID: 42.9 pp), adequate weight gain (DID: 35.1 pp), and breastfeeding (DID: 25.9 pp). Women in intervention areas consumed more IFA supplements during pregnancy (DID: 21 tablets). Early initiation of and exclusive breastfeeding also improved (DID: 17.0 and 8.3 pp, respectively). However, dietary diversity (4 out of 10 food groups) and mean probability of adequacy of micronutrient intake (14%) among pregnant women remained low in both areas. CONCLUSIONS: Strengthening maternal nutrition interventions delivered through government ANC services was feasible and effective in improving maternal nutrition practices. Continued efforts to strengthen the delivery and use of maternal nutrition services may be required for greater behavior changes, and to address family support, social norms, and other factors to improve women's diets during pregnancy.

Post-Recovery Relapse of Children Treated with a Simplified, Combined Nutrition Treatment Protocol in Mali: A Prospective Cohort Study.

The present study aimed to determine the 6-month incidence of relapse and associated factors among children who recovered from acute malnutrition (AM) following mid-upper arm circumference (MUAC)-based simplified combined treatment using the ComPAS protocol. A prospective cohort of 420 children who had reached a MUAC ≥ 125 mm for two consecutive measures was monitored between December 2020 and October 2021. Children were seen at home fortnightly for 6 months. The overall 6-month cumulative incidence of relapse [95%CI] into MUAC < 125 mm and/or edema was 26.1% [21.7; 30.8] and 1.7% [0.6; 3.6] to MUAC < 115 mm and/or edema. Relapse was similar among children initially admitted to treatment with a MUAC < 115 mm and/or oedema and among those with a MUAC ≥ 115 mm but <125 mm. Relapse was predicted by lower anthropometry both at admission to and discharge from treatment, and a higher number of illness episodes per month of follow-up. Having a vaccination card, using an improved water source, having agriculture as the main source of income, and increases in caregiver workload during follow-up all protected from relapse. Children discharged as recovered from AM remain at risk of relapsing into AM. To achieve reduction in relapse, recovery criteria may need to be revised and post-discharge strategies tested.

Multiple modifiable maternal, household and health service factors are associated with maternal nutrition and early breastfeeding practices in Burkina Faso.

Low coverage of effective nutrition interventions in many high-burden countries, due to service provision and demand factors, result in poor uptake of recommended practices and nutrition outcomes. We examined the factors that influence maternal nutrition and early breastfeeding practices and determined the extent that the key factors could improve these practices in two regions in Burkina Faso. We used household survey data among pregnant (n = 920) and recently delivered women (n = 1840). Multivariable regression analyses were conducted to identify the determinants of a diverse diet and iron-folic acid (IFA) supplement consumption, weight monitoring during pregnancy and early initiation of breastfeeding (EIBF). Population attributable risk analysis was used to estimate how much the outcomes can be improved under optimal conditions of interventions that address the modifiable determinants. During pregnancy, 21% of women achieved minimum diet diversity (MDD-W), 70% consumed 90+ IFA tablets and 65% were weighed 4+ times; EIBF was 40%. Nutrition knowledge was associated with MDD-W (odds ratio [OR]: 3.2), 90+ IFA (OR: 1.5) and EIBF (OR: 1.9). Positive social norms and family support were associated with 90+ IFA (OR: 1.5). Early and 4+ ANC visits were associated with 90+ IFA (OR: 1.5 and 10) and 4+ weight monitoring (OR: 6.2). Nutrition counselling was associated with 90+ IFA (OR: 2.5) and EIBF (OR: 1.5). Under optimal programme conditions, 41% of women would achieve MDD-W, 93% would consume 90+ IFA, 93% would be weighed 4+ times and 57% would practice EIBF. Strengthening the delivery and uptake of interventions targeted at these modifiable factors has the potential to improve maternal nutrition practices.

Prevalence and determinants of gestational weight gain among pregnant women in Niger.

Low gestational weight gain (GWG) and low mid-upper arm circumference (MUAC) are associated with adverse pregnancy outcomes. We aimed to assess the prevalence and determinants of low GWG and low MUAC among pregnant women in rural Zinder, Niger. A community-based survey was conducted among 1,384 pregnant women in the catchment areas of 18 integrated health centers in the region of Zinder, Niger. Weight and MUAC were measured during an in-home visit and again 1 month later, when haemoglobin concentration and micronutrient status were also assessed. The prevalence of low GWG was defined based on the 2009 United States Institute of Medicine (U.S. IOM) guidelines (<0.35 kg/week) and less than the third centile of the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) standards. Factors associated with GWG and MUAC were identified using logistic regression models adjusting for season, village, and gestational age. The median (interquartile range) age was 25.0 (20.7, 30.0) years, and 16.4% were ≤19 years. The prevalence of low GWG were 62.9% and 27.5% according to 2009 IOM and less than the third INTERGROWTH-21st centile, respectively; 24.9% had low MUAC. Higher α-1-acid glycoprotein (OR = 1.7, 95% CI [1.1, 2.8]) and C-reactive protein (OR = 1.2, 95% CI [1.02, 1.50]) increased the odds of low GWG. Adolescents (OR = 2.7, 95% CI [1.8, 4.0]), housewives (OR = 1.97, 95% CI [1.36, 2.86]), and those who reported recent food assistance (OR = 1.80, 95% CI [1.04, 3.11]) had higher odds of low MUAC. Prevalence of low GWG and low MUAC was high among pregnant women. Determinants of GWG and MUAC included socio-economic, demographic, and biological factors, although only markers of inflammation were consistent predictors across different definitions of low GWG.

Assessment of Dietary Intake and Nutrient Gaps, and Development of Food-Based Recommendations, among Pregnant and Lactating Women in Zinder, Niger: An Optifood Linear Programming Analysis.

Pregnant and lactating women in rural Niger are at high risk for inadequate intakes of multiple micronutrients. Thus, 24 h dietary recalls were conducted and analyzed for dietary intakes in this population (n = 202). Using linear programming analyses, micronutrient gaps in women's diets were identified, food-based recommendations (FBR) to improve dietary micronutrient adequacy were developed, and various supplementation strategies were modelled. Energy intakes were below estimated requirements, and, for most micronutrients, >50% of women were at risk of inadequate intakes. Linear programming analyses indicated it would be difficult to select a diet that achieved recommended dietary allowances for all but three (vitamin B6, iron and zinc) of 11 modeled micronutrients. Consumption of one additional meal per day, and adherence to the selected FBR (daily consumption of dark green leafy vegetables, fermented milk, millet, pulses, and vitamin A fortified oil), would result in a low percentage of women at risk of inadequate intakes for eight modeled micronutrients (vitamin A, riboflavin, thiamin, B6, folate, iron, zinc, and calcium). Because the promotion of realistic FBRs likely will not ensure that a low percentage of women are at risk of inadequate intakes for all modeled micronutrients, multiple micronutrient supplementation or provision of nutrient-dense foods should be prioritized.

The mixed effects of a package of multilevel interventions on the health and care of pregnant women in Zinder, Niger.

BACKGROUND: Anaemia is prevalent among pregnant women in rural Niger and antenatal care (ANC) attendance is suboptimal. We designed a programmatic intervention including community-based behaviour change communication, provision of essential drugs (including iron folic acid (IFA) supplements) and quality improvement activities at selected integrated health centres (IHCs). OBJECTIVE: To assess the impact of the programmatic intervention on: (1) utilisation of ANC, (2) adherence to daily IFA supplementation and (3) prevalence of adequate gestational weight gain (GWG) and anaemia among pregnant women in Zinder, Niger. METHODS: Using a quasi-experimental study design comparing a cohort of women at baseline to another cohort of women at endline, 18 IHCs and surrounding villages were randomly assigned to time of enrolment over 1 year. A baseline survey was implemented among randomly selected pregnant women in 68 village clusters. Subsequently, the intervention was rolled out and an endline survey was implemented 6 months later in the same villages. RESULTS: Mean age in the baseline (n=1385) and endline (n=922) surveys was 25.8±6.4 years. The percentage of pregnant women who reported attending any number of ANC and an adequate number of ANC for their gestational age, respectively, was not significantly different between the endline and the baseline surveys. Pregnant women in the endline survey were more likely to have received IFA (60.0% vs 45.8%, OR: 2.7 (1.2, 6.1)); and the proportion of pregnant women who reportedly consumed IFA daily in the previous 7 days was significantly higher in the endline than in the baseline survey (46.4% vs 32.8%, OR: 2.8 (1.2, 6.5)). There was no impact on the prevalence of adequate GWG or anaemia. CONCLUSIONS: The programmatic intervention resulted in a modest increase in the number of pregnant women who reported receiving and consuming IFA supplements as recommended, but did not affect ANC attendance and nutritional status.

Prevalence of and factors associated with antenatal care seeking and adherence to recommended iron-folic acid supplementation among pregnant women in Zinder, Niger.

The World Health Organization recommends iron and folic acid (IFA) supplementation for pregnant women. The high prevalence of anaemia among pregnant women in Niger warrants better understanding of the utilization of antenatal care (ANC) and IFA. We aimed to assess the prevalence of and factors associated with ANC coverage and adherence to IFA recommendation among pregnant women. Pregnant women (n = 923) from 64 randomly selected villages within the catchment area of 12 health centres were interviewed during a baseline household survey in Zinder, Niger. ANC and IFA coverage were 60.1% and 43.6%, respectively. Only 71.7% of women who attended ANC received IFA. Of the 401 women who reportedly received any IFA supplements, 99.3% had attended any ANC during their current pregnancy and 68.6% reported adherence to recommended IFA supplementation (i.e., consumed IFA every day in the previous week). Women with gestational age ≥27 weeks were more likely to have attended ANC than women with gestational age <27 weeks (85.9% vs. 27.5%, odds ratio [OR]: 21.81, 95% confidence interval [CI]: 13.81, 34.45). Women who reportedly received husbands' advice about attending ANC were more likely to attend ANC (OR: 1.48, 95% CI [1.03, 2.11]) and adhere to IFA recommendations (OR: 1.80, 95% CI [1.04, 3.13]) compared to those who did not receive any advice. ANC attendance is crucial to ensure distribution of IFA supplementation among pregnant women in Zinder. Interventions to improve ANC and IFA adherence will require promotion of early ANC, ensure availability of IFA at ANC, and involve husbands in ANC.

Using formative research to promote antenatal care attendance and iron folic acid supplementation in Zinder, Niger.

In Niger, use of antenatal care (ANC) and iron folic acid (IFA) supplements is suboptimal. The objectives of this paper are as follows: (a) to conduct formative research to understand barriers and beliefs among pregnant women related to ANC, IFA supplementation, and pregnancy outcomes; (b) assess the quality of currently provided ANC services; (c) use the findings to guide the development of programmatic interventions to improve coverage of ANC services and IFA supplementation of pregnant women. Structured in-home interviews (n = 72) and focus groups (n = 4) were conducted with pregnant women in 4 randomly selected villages in rural Zinder. ANC consultations (n = 33) were observed in 5 randomly selected health centres, and exit interviews were conducted with all pregnant women and seven health agents following these observations. During workshops with stakeholders, results of the formative research were interpreted, and programmatic interventions were developed. In home interviews, 72% of women reported having attended at least one ANC visit. They also reported husbands (71%), mothers (40%), and friends (33%) supporting ANC attendance. Among those having attended ANC, only 65% reported taking IFA the day prior to the interview. Three of five health centres visited had IFA in stock. Health staff did not provide IFA supplements during 18 of 33 observed ANC consultations of which only 7 cases could be explained by the lack of IFA supplements in stock. Findings were used to design a 3-pronged intervention: (a) behaviour change communication activities in communities; (b) quality improvement activities in health centres to strengthen ANC; and (c) provision of key supplies required for ANC.

Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS).

BACKGROUND: Of two community-based trials among young children in neighboring health districts of Burkina Faso, one found that small-quantity lipid-based nutrient supplements (LNS) increased child growth compared with a non-intervention control group, but zinc supplementation did not in the second study. OBJECTIVES: We explored whether the disparate growth outcomes were associated with differences in intervention components, household demographic variables, and/or children's morbidity. METHODS: Children in the LNS study received 20g LNS daily containing different amounts of zinc (LNS). Children in the zinc supplementation study received different zinc supplementation regimens (Z-Suppl). Children in both studies were visited weekly for morbidity surveillance. Free malaria and diarrhea treatment was provided by the field worker in the LNS study, and by a village-based community-health worker in the zinc study. Anthropometric assessments were repeated every 13-16 weeks. For the present analyses, study intervals of the two studies were matched by child age and month of enrollment. The changes in length-for-age z-score (LAZ) per interval were compared between LNS and Z-Suppl groups using mixed model ANOVA or ANCOVA. Covariates were added to the model in blocks, and adjusted differences between group means were estimated. RESULTS: Mean ages at enrollment of LNS (n = 1716) and Z-Suppl (n = 1720) were 9.4±0.4 and 10.1±2.7 months, respectively. The age-adjusted change in mean LAZ per interval declined less with LNS (-0.07±0.44) versus Z-Suppl (-0.21±0.43; p<0.0001). There was a significant group by interval interaction with the greatest difference found in 9-12 month old children (p<0.0001). Adjusting for demographic characteristics and morbidity did not reduce the observed differences by type of intervention, even though the morbidity burden was greater in the LNS group. CONCLUSIONS: Greater average physical growth in children who received LNS could not be explained by known cross-trial differences in baseline characteristics or morbidity burden, implying that the observed difference in growth response was partly due to LNS.

Factors Affecting the Validity of Coverage Survey Reports of Receipt of Vitamin A Supplements During Child Health Days in Southwestern Burkina Faso.

BACKGROUND: Assessment of high-dose vitamin A supplementation (VAS) coverage often relies on postevent coverage (PEC) surveys, but the validity of these methods has rarely been evaluated. OBJECTIVES: To assess reported VAS coverage and factors associated with missed coverage and to investigate the reliability of the results. METHODS: During a cross-sectional survey, 10 454 caregivers of children <27 months old were asked whether their child had received VAS in the past 6 months. During a 48-week longitudinal study of 6232 children 6 to 30 months old, caregivers were asked every 4 weeks if their child had received VAS in the past 4 weeks. RESULTS: The cross-sectional study showed that 94.4% (95% confidence interval [CI]: 93.8%, 94.9%) of eligible children 6 to 26 months of age reportedly received VAS in the previous 6 months, as did 85.8% (CI: 84.5%, 87.2%) of ineligible, 0 to 5 months old children. The longitudinal study showed that 81.6% of children surveyed within 4 weeks following a VAS campaign reportedly received VAS during the campaign and 13.4% of caregivers incorrectly reported receiving VAS when no campaign had actually occurred. False-positive reporting was more likely when oral polio vaccine (OPV) was distributed during the reporting period (20.6% vs 5.4%; P < .001). Showing a photo of OPV during the interview reduced the odds ratio (OR) of false-positive reports (OR = 0.7 [0.6-0.8]). CONCLUSIONS: The PEC surveys should include children outside the target age to assess targeting efficiency, and pictures of both VAS and oral vaccines distributed during the same period should be shown during interviews to enhance reporting accuracy.

Comparison of Preventive and Therapeutic Zinc Supplementation in Young Children in Burkina Faso: A Cluster-Randomized, Community-Based Trial.

BACKGROUND: The WHO and UNICEF recommend therapeutic zinc supplementation (TZS) for the treatment of diarrhea. In zinc-deficient populations, preventive zinc supplementation might provide greater benefits for reducing diarrhea and malaria incidence and increasing growth and plasma zinc (pZn) concentration. If effective, intermittent preventive zinc supplementation (IPZS) would cost less than daily preventive zinc supplementation (DPZS). OBJECTIVE: We assessed the effects of IPZS, DPZS, and TZS in children on the primary outcomes of diarrhea incidence, malaria incidence, growth, and pZn concentration compared with nonsupplemented control groups. METHODS: Rural Burkinabe children (n = 7641; 6-30 mo old) in 36 clusters were randomly assigned to 1 of 5 treatment groups for 16, 32, or 48 wk: 1) IPZS (10 mg Zn/d for 10 d every 16 wk); 2) DPZS (7 mg Zn/d); 3) TZS (20 mg Zn/d for 10 d for diarrhea); 4) morbidity surveillance control (MSC); or 5) nonintervention control (NIC). Supplemented groups remained masked until completion of primary analyses with mixed models. RESULTS: At baseline, stunting (28.6%) and low pZn concentration (<65 µg/dL; 43.5%) were common. After 48 wk, mean ± SE pZn increased more (P = 0.008) in the DPZS group (3.9 ± 1.3 µg/dL) than in the TZS (-0.5 ± 1.2 µg/dL) and NIC (-1.2 ± 0.9 µg/dL) groups. All supplemented groups had a moderately lower incidence of reported diarrhea (0.48-0.49 compared with 0.57 episodes/100 d, P = 0.001) and reported fever (1.1-1.2 compared with 1.5 episodes/100d, P < 0.001) and gained slightly less length (3.15-3.20 compared with 3.36 cm/16 wk, P < 0.001) than the MSC group, but did not differ from each other. Prevalence of diarrhea and incidences of confirmed fever and malaria were not different across study groups. CONCLUSIONS: The preventive and TZS groups had reduced diarrhea incidence, but it is uncertain whether this resulted from a functional response to zinc or reporting bias. The comparison should be re-examined in populations known to respond to zinc supplementation. This trial was registered at www.clinicaltrials.gov as NCT00944359.

Caregiver recognition of childhood diarrhea, care seeking behaviors and home treatment practices in rural Burkina Faso: a cross-sectional survey.

INTRODUCTION: To design effective national diarrhea control programs, including oral rehydration solution (ORS) and therapeutic zinc supplementation, information is needed on local perceptions of illness, external care seeking behaviors, and home treatment practices. METHODS: A cross-sectional, community-based household survey was conducted in the Orodara Health District, Burkina Faso. Caregivers of 10,490 children <27 months were interviewed to assess child diarrhea prevalence and related care practices. Characteristics of households, caregivers, children, and reported illnesses were compared for those caregivers who did or did not recognize the presence of diarrhea, as defined according to clinical criteria (≥ 3 liquid or semi-liquid stools/day). Multiple logistic regression models were used to examine factors associated with illness recognition and treatment. RESULTS: Clinically defined diarrhea was present in 7.6% (95% CI: 7.1-8.1%) of children during the 24 hours preceding the survey but recognized by only 55% of caregivers. Over half (55%) of the caregivers of 1,067 children with a clinically defined diarrhea episode in the past 14 days sought care outside the home; 78% of those seeking care attended a public sector clinic. Care was sought and treatment provided more frequently for children with fever, vomiting, anorexia, longer illness duration, and those living closer to the health center; and care was sought more frequently for male children. 80% of children with recent diarrhea received some form of treatment; only 24% received ORS, whereas 14% received antibiotics. Zinc was not yet available in the study area. CONCLUSIONS: Caregivers frequently fail to recognize children's diarrhea, especially among younger infants and when illness signs are less severe. Treatment practices do not correspond with international recommendations in most cases, even when caregivers consult with formal health services. Child caregivers need additional assistance to recognize diarrhea correctly, and both caregivers and health care providers need updated training on current diarrhea treatment recommendations.