Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

BACKGROUND: Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy-protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. METHODS AND FINDINGS: A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (-3.18 percentage points (pp), 95% CI [-5.86 to -0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (-2.74 pp, 95% CI [-5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. CONCLUSIONS: This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03533712.

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso.

BACKGROUND: Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. METHODS AND FINDINGS: The MISAME-III study is an open label individually randomized controlled trial where pregnant women (n = 1,897) of gestational age <21 weeks received either a combination of micronutrient-fortified BEP and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control). The prenatal phase of the MISAME-III study was conducted between the first enrollment in October 2019 and the last delivery in August 2021. In a sub-study nested under the MISAME-III trial, we evaluated anthropometry and body composition in newborns who were born starting from 17 November 2020 (n: control = 368 and intervention = 352) and their mothers (n: control = 185 and intervention = 186). Primary study outcomes were newborn and maternal fat-free mass (FFMI) and fat-mass (FMI) indices. We used the deuterium dilution method to determine FFMI and FMI and %FFM and %FM of total body weight within 1 month postpartum. Our main analysis followed a modified intention-to-treat approach by analyzing all subjects with body composition data available. Univariable and multivariable linear regression models were fitted to compare the intervention and control arms, with adjusted models included baseline maternal age, height, arm fat index, hemoglobin concentration and primiparity, household size, wealth and food security indices, and newborn age (days). At study enrollment, the mean ± SD maternal age was 24.8 ± 6.13 years and body mass index (BMI) was 22.1 ± 3.02 kg/m2 with 7.05% of the mothers were underweight and 11.5% were overweight. Prenatal micronutrient-fortified BEP supplementation resulted in a significantly higher FFMI in mothers (MD (mean difference): 0.45; 95% CI (confidence interval): 0.05, 0.84; P = 0.026) and newborns (MD: 0.28; 95% CI: 0.06, 0.50; P = 0.012), whereas no statistically significant effects were found on FMI. The effect of micronutrient-fortified BEP on maternal FFMI was greater among mothers from food secure households and among those with a better nutritional status (BMI ≥21.0 kg/m2 or mid-upper arm circumference (MUAC) ≥23 cm). Key limitations of the study are the relatively high degree of missing data (approximately 18%), the lack of baseline maternal body composition values, and the lack of follow-up body composition measurements to evaluate any long-term effects. CONCLUSIONS: Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. TRIAL REGISTRATION: ClinicalTrials.gov with identifier NCT03533712.

Correction: Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1004186.].

Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial.

BACKGROUND: Providing balanced energy-protein (BEP) supplements is a promising intervention to improve birth outcomes in low- and middle-income countries (LMICs); however, evidence is limited. We aimed to assess the efficacy of fortified BEP supplementation during pregnancy to improve birth outcomes, as compared to iron-folic acid (IFA) tablets, the standard of care. METHODS AND FINDINGS: We conducted an individually randomized controlled efficacy trial (MIcronutriments pour la SAnté de la Mère et de l'Enfant [MISAME]-III) in 6 health center catchment areas in rural Burkina Faso. Pregnant women, aged 15 to 40 years with gestational age (GA) <21 completed weeks, were randomly assigned to receive either fortified BEP supplements and IFA (intervention) or IFA (control). Supplements were provided during home visits, and intake was supervised on a daily basis by trained village-based project workers. The primary outcome was prevalence of small-for-gestational age (SGA) and secondary outcomes included large-for-gestational age (LGA), low birth weight (LBW), preterm birth (PTB), gestational duration, birth weight, birth length, Rohrer's ponderal index, head circumference, thoracic circumference, arm circumference, fetal loss, and stillbirth. Statistical analyses followed the intention-to-treat (ITT) principle. From October 2019 to December 2020, 1,897 pregnant women were randomized (960 control and 937 intervention). The last child was born in August 2021, and birth anthropometry was analyzed from 1,708 pregnancies (872 control and 836 intervention). A total of 22 women were lost to follow-up in the control group and 27 women in the intervention group. BEP supplementation led to a mean 3.1 percentage points (pp) reduction in SGA with a 95% confidence interval (CI) of -7.39 to 1.16 (P = 0.151), indicating a wide range of plausible true treatment efficacy. Adjusting for prognostic factors of SGA, and conducting complete cases (1,659/1,708, 97%) and per-protocol analysis among women with an observed BEP adherence ≥75% (1,481/1,708, 87%), did not change the results. The intervention significantly improved the duration of gestation (+0.20 weeks, 95% CI 0.05 to 0.36, P = 0.010), birth weight (50.1 g, 8.11 to 92.0, P = 0.019), birth length (0.20 cm, 0.01 to 0.40, P = 0.044), thoracic circumference (0.20 cm, 0.04 to 0.37, P = 0.016), arm circumference (0.86 mm, 0.11 to 1.62, P = 0.025), and decreased LBW prevalence (-3.95 pp, -6.83 to -1.06, P = 0.007) as secondary outcomes measures. No differences in serious adverse events [SAEs; fetal loss (21 control and 26 intervention) and stillbirth (16 control and 17 intervention)] between the study groups were found. Key limitations are the nonblinded administration of supplements and the lack of information on other prognostic factors (e.g., infection, inflammation, stress, and physical activity) to determine to which extent these might have influenced the effect on nutrient availability and birth outcomes. CONCLUSIONS: The MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. However, the intervention had a small positive effect on other birth outcomes. Additional maternal and biochemical outcomes need to be investigated to provide further evidence on the overall clinical relevance of BEP supplementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03533712.

Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso.

BACKGROUND: Panel data indicate that nonpregnant women's dietary diversity fluctuates across climatic seasons in low- and middle-income countries. The natural day-to-day variability in food group consumption during gestation is unknown. OBJECTIVES: A longitudinal study was conducted among pregnant women enrolled in the Micronutriments pour la Santé de la Mère et de l'Enfant study 3 randomized controlled efficacy trial [i.e., daily fortified balanced energy-protein supplement and an iron-folic acid (IFA) tablet compared with an IFA tablet only] to investigate the number of 24-hour recalls required to estimate usual prenatal food group (FG) diversity and the seasonality of pregnant women's dietary diversity in Houndé, Burkina Faso. METHODS: FG consumption was assessed twice weekly by qualitative, list-based, 24-hour recalls among 1757 pregnant women (892 control, 865 intervention). The number of days needed to estimate a woman's usual prenatal 10-point FG diversity score was calculated using the within-subject coefficient of variation. Regression models, including truncated Fourier series, were fitted to assess seasonal variations in the FG diversity score and the probability of reaching Minimum Dietary Diversity for Women (MDD-W; i.e., ≥5 FGs). RESULTS: The monthly mean FG scores (<5 FGs) and MDD-W prevalence (<45%) were low. Five list-based recalls allowed observed FG diversity to lie within 15% of the true mean in 90% of the estimations (mean ± SD, 40.4 ± 20.7 recalls per woman). Both the FG diversity score and prevalence achieving MDD-W showed responsiveness to seasonal variations, with peaks at the end of the dry season (i.e., April or May) and troughs in the rainy season (i.e., August). CONCLUSIONS: Five list-based recalls are sufficient to estimate usual FG diversity during gestation, although intra-annual seasonal patterns did modestly affect the FG diversity score and MDD-W prevalence. Thus, timing of repeated dietary surveys is critical to ensure nonbiased inferences of change and trends in Burkina Faso. This trial was registered at clinicaltrials.gov as NCT03533712.

Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.

BACKGROUND: Anemia and suboptimal gestational weight gain (GWG) are associated with adverse maternal and birth outcomes. Limited research indicates that balanced energy-protein (BEP) supplements reduce the incidence of inadequate GWG. OBJECTIVES: We assessed the efficacy of a micronutrient-fortified BEP supplement on the secondary outcomes of anemia, GWG, GWG rate, and GWG in relation to the Institute of Medicine (IOM)'s recommendations, as compared with an iron-folic acid (IFA) tablet. METHODS: We conducted a randomized controlled trial in Burkina Faso, among pregnant women (15-40 y old) enrolled at <21 weeks of gestation. Women received either BEP and IFA (intervention) or IFA (control). Hemoglobin (g/dL) concentrations were measured at baseline and the third antenatal care visit (ANC), whereas maternal weight was measured at baseline and all subsequent ∼7-weekly ANCs. GWG (kg) was calculated as a woman's last weight measurement (at ∼36 weeks of gestation) minus weight at enrollment, whereas GWG rate (kg/wk) was GWG divided by the time between the first and last weight measurements. GWG adequacy (%) was computed as GWG divided by the IOM's recommendation. Binary outcomes included severely inadequate, inadequate, and excessive GWG. Statistical analyses followed the intention-to-treat principle. Linear regression and probability models were fitted for the continuous and binary outcomes, respectively, adjusting for baseline measurements. RESULTS: Women in the BEP group tended to have higher, but nonsignificantly different, GWG (0.28 kg; 95% CI: -0.05, 0.58 kg; P = 0.099). Furthermore, there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or incidence of inadequate or excessive GWG. Findings were robust to model adjustments and complete case and per protocol analyses. CONCLUSIONS: This trial does not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG, as compared with IFA. In conjunction with the small, but positive, effects of maternal BEP supplementation on birth outcomes, our findings warrant the investigation of additional biochemical and postnatal outcomes.This trial was registered at clinicaltrials.gov as NCT03533712.

Infant and young child feeding practices and child linear growth in Nepal: Regression-decomposition analysis of national survey data, 1996-2016.

Suboptimal infant and young child feeding (IYCF) practices have profound implications on child survival, health, growth, and development. First, our study analysed trends in 18 IYCF indicators and height-for-age z-score (HAZ) and stunting prevalence across Nepal's Family Health Survey 1996 and four rounds of Nepal Demographic and Health Surveys from 2001-2016. Second, we constructed multivariable regression models and decomposed the contribution of optimal IYCF practices on HAZ and stunting prevalence over the 1996-2016 period. Our findings indicate that most age-appropriate IYCF practices and child linear growth outcomes improved over the past two decades. At present, according to the World Health Organization's tool for national assessment of IYCF practices, duration of breastfeeding is rated very good, early initiation of breastfeeding and exclusive breastfeeding (EBF) are rated good, whereas minimal bottle-feeding and introduction of solid, semi-solid or soft foods are rated fair. Our study also reports that a paucity of age-appropriate IYCF practices-in particular complementary feeding-are significantly associated with increased HAZ and decreased probability of stunting (p < .05). Moreover, age-appropriate IYCF practices-in isolation-made modest statistical contributions to the rapid and sustained reduction in age-specific child linear growth faltering from 1996-2016. Nevertheless, our findings indicate that comprehensive multisectoral nutrition strategies-integrating and advocating optimal IYCF-are critical to further accelerate the progress against child linear growth faltering. Furthermore, specific focus is needed to improve IYCF practices that have shown no significant development over the past two decades in Nepal: EBF, minimum acceptable diet, and minimal bottle-feeding.

Elucidating the sustained decline in under-three child linear growth faltering in Nepal, 1996-2016.

Childhood linear growth faltering remains a major public health concern in Nepal. Nevertheless, over the past 20 years, Nepal sustained one of the most rapid reductions in the prevalence of stunting worldwide. First, our study analysed the trends in height-for-age z-score (HAZ), stunting prevalence, and available nutrition-sensitive and nutrition-specific determinants of linear growth faltering in under-three children across Nepal's Family Health Survey 1996 and Nepal's Demographic and Health Surveys 2001, 2006, 2011, and 2016. Second, we constructed pooled multivariable linear regression models and decomposed the contributions of our time-variant determinants on the predicted changes in HAZ and stunting over the past two decades. Our findings indicate substantial improvements in HAZ (38.5%) and reductions in stunting (-42.6%) and severe stunting prevalence (-63.9%) in Nepalese children aged 0-35 months. We also report that the increment in HAZ, across the 1996-2016 period, was significantly associated (confounder-adjusted p < .05) with household asset index, maternal and paternal years of education, maternal body mass index and height, basic child vaccinations, preceding birth interval, childbirth in a medical facility, and prenatal doctor visits. Furthermore, our quantitative decomposition of HAZ identified advances in utilisation of health care and related services (31.7% of predicted change), household wealth accumulation (25%), parental education (21.7%), and maternal nutrition (8.3%) as key drivers of the long-term and sustained progress against child linear growth deficits. Our research reiterates the multifactorial nature of chronic child undernutrition and the need for coherent multisectoral nutrition-sensitive and nutrition-specific strategies at national scale to further improve linear growth in Nepal. [Correction added on 6 November 2020, after first online publication: in abstract, the citation year in the fourth sentence has been changed from '2001' to '2011'.].

Food biodiversity and total and cause-specific mortality in 9 European countries: An analysis of a prospective cohort study.

BACKGROUND: Food biodiversity, encompassing the variety of plants, animals, and other organisms consumed as food and drink, has intrinsic potential to underpin diverse, nutritious diets and improve Earth system resilience. Dietary species richness (DSR), which is recommended as a crosscutting measure of food biodiversity, has been positively associated with the micronutrient adequacy of diets in women and young children in low- and middle-income countries (LMICs). However, the relationships between DSR and major health outcomes have yet to be assessed in any population. METHODS AND FINDINGS: We examined the associations between DSR and subsequent total and cause-specific mortality among 451,390 adults enrolled in the European Prospective Investigation into Cancer and Nutrition (EPIC) study (1992 to 2014, median follow-up: 17 years), free of cancer, diabetes, heart attack, or stroke at baseline. Usual dietary intakes were assessed at recruitment with country-specific dietary questionnaires (DQs). DSR of an individual's yearly diet was calculated based on the absolute number of unique biological species in each (composite) food and drink. Associations were assessed by fitting multivariable-adjusted Cox proportional hazards regression models. In the EPIC cohort, 2 crops (common wheat and potato) and 2 animal species (cow and pig) accounted for approximately 45% of self-reported total dietary energy intake [median (P10-P90): 68 (40 to 83) species consumed per year]. Overall, higher DSR was inversely associated with all-cause mortality rate. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing total mortality in the second, third, fourth, and fifth (highest) quintiles (Qs) of DSR to the first (lowest) Q indicate significant inverse associations, after stratification by sex, age, and study center and adjustment for smoking status, educational level, marital status, physical activity, alcohol intake, and total energy intake, Mediterranean diet score, red and processed meat intake, and fiber intake [HR (95% CI): 0.91 (0.88 to 0.94), 0.80 (0.76 to 0.83), 0.69 (0.66 to 0.72), and 0.63 (0.59 to 0.66), respectively; PWald < 0.001 for trend]. Absolute death rates among participants in the highest and lowest fifth of DSR were 65.4 and 69.3 cases/10,000 person-years, respectively. Significant inverse associations were also observed between DSR and deaths due to cancer, heart disease, digestive disease, and respiratory disease. An important study limitation is that our findings were based on an observational cohort using self-reported dietary data obtained through single baseline food frequency questionnaires (FFQs); thus, exposure misclassification and residual confounding cannot be ruled out. CONCLUSIONS: In this large Pan-European cohort, higher DSR was inversely associated with total and cause-specific mortality, independent of sociodemographic, lifestyle, and other known dietary risk factors. Our findings support the potential of food (species) biodiversity as a guiding principle of sustainable dietary recommendations and food-based dietary guidelines.

Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso.

BACKGROUND: In many low- and middle-income countries, the prevalence of energy and nutrient deficiencies is high among pregnant women. Balanced energy-protein (BEP) supplements are a promising strategy to cover nutritional requirements during pregnancy and improve birth outcomes. However, the displacement of nutrient-dense foods by BEP might attenuate the efficacy of supplementation. OBJECTIVE: This cross-sectional study of participants in a randomized controlled trial evaluated the difference in energy and macro- and micronutrient intakes, food groups, and nutrient adequacy between a control and intervention group receiving either a daily iron-folic acid (IFA) tablet or IFA and BEP supplement during pregnancy, respectively. METHODS: We collected a single multiple-pass 24-h recall from 470 pregnant women from the MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III study that investigates the efficacy of BEP supplementation on birth outcomes and infant growth. Dietary intake (median and IQR) and nutrient adequacy were assessed using individual recipes and preparation methods of mixed dishes for each participant. Linear regression models were fitted to compare energy and nutrient intakes. RESULTS: Dietary energy, and macro- and micronutrient intakes were significantly higher among women in the intervention group when including BEP [2329 kcal/d (1855, 3008 kcal/d) compared with 1942 kcal/d (1575, 2405 kcal/d) in the control group (all P < 0.001)]. The difference in median energy intake (448 kcal/d; 95% CI: 291, 605 kcal/d) was approximately equivalent to a daily dose of the BEP supplement (393 kcal). Nutrient adequacy ratios for both groups were low for all micronutrients (between 0.02 and 0.66), when excluding BEP (except iron and folic acid, due to standard supplemental doses) from analysis. However, nutrient intakes increased to the Estimated Average Requirement for pregnant women when including BEP supplements. CONCLUSIONS: BEP supplementation increases energy and macro- and micronutrient intakes among pregnant women and fills nutrient gaps without displacing food intake. This trial was registered at clinicaltrials.gov as NCT03533712 (https://clinicaltrials.gov/ct2/show/NCT03533712).

EAT-Lancet diet score requires minimum intake values to predict higher micronutrient adequacy of diets in rural women of reproductive age from five low- and middle-income countries.

The EAT-Lancet Commission promulgated a universal reference diet. Subsequently, researchers constructed an EAT-Lancet diet score (0-14 points), with minimum intake values for various dietary components set at 0 g/d, and reported inverse associations with risks of major health outcomes in a high-income population. We assessed associations between EAT-Lancet diet scores, without or with lower bound values, and the mean probability of micronutrient adequacy (MPA) among nutrition-insecure women of reproductive age (WRA) from low- and middle-income countries (LMIC). We analysed single 24-h diet recall data (n 1950) from studies in rural DRC, Ecuador, Kenya, Sri Lanka and Vietnam. Associations between EAT-Lancet diet scores and MPA were assessed by fitting linear mixed-effects models. Mean EAT-Lancet diet scores were 8·8 (SD 1·3) and 1·9 (SD 1·1) without or with minimum intake values, respectively. Pooled MPA was 0·58 (SD 0·22) and energy intake was 10·5 (SD 4·6) MJ/d. A one-point increase in the EAT-Lancet diet score, without minimum intake values, was associated with a 2·6 (SD 0·7) percentage points decrease in MPA (P < 0·001). In contrast, the EAT-Lancet diet score, with minimum intake values, was associated with a 2·4 (SD 1·3) percentage points increase in MPA (P = 0·07). Further analysis indicated positive associations between EAT-Lancet diet scores and MPA adjusted for energy intake (P < 0·05). Our findings indicate that the EAT-Lancet diet score requires minimum intake values for nutrient-dense dietary components to avoid positively scoring non-consumption of food groups and subsequently predicting lower MPA of diets, when applied to rural WRA in LMIC.

Prognostic factors and outcomes of COVID-19 cases in Ethiopia: multi-center cohort study protocol.

BACKGROUND: The coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2) and became pandemic after emerging in Wuhan, China, in December 2019. Several studies have been conducted to understand the key features of COVID-19 and its public health impact. However, the prognostic factors of COVID-19 are not well studied in the African setting. In this study, we aim to determine the epidemiological and clinical features of COVID-19 cases, immunological and virological courses, interaction with nutritional status, and response to treatment for COVID-19 patients in Ethiopia. METHODS: A multi-center cohort study design will be performed. Patients with confirmed COVID-19 infection admitted to selected treatment centers will be enrolled irrespective of their symptoms and followed-up for 12 months. Baseline epidemiological, clinical, laboratory and imaging data will be collected from treatment records, interviews, physical measurements, and biological samples. Follow-up data collection involves treatment and prognostic outcomes to be measured using different biomarkers and clinical parameters. Data collection will be done electronically using the Open Data Kit (ODK) software package and then exported to STATA/SPSS for analysis. Both descriptive and multivariable analyses will be performed to assess the independent determinants of the treatment outcome and prognosis to generate relevant information for informed prevention and case management. The primary outcomes of this study are death/survival and viral shedding. Secondary outcomes include epidemiological characteristics, clinical features, genetic frequency shifts (genotypic variations), and nutritional status. DISCUSSION: This is the first large prospective cohort study of patients in hospitals with COVID-19 in Ethiopia. The results will enable us to better understand the epidemiology of SARS-CoV-2 in Africa. This study will also provide useful information for effective public health measures and future pandemic preparedness and in response to outbreaks. It will also support policymakers in managing the epidemic based on scientific evidence. TRIAL REGISTRATION: The Protocol prospectively registered in ClinicalTrials.gov (NCT04584424) on 30 October, 2020.

Maternal nutritional status mediates the association between maternal age and birth outcomes.

Young maternal age during pregnancy is linked with adverse birth outcomes. This study examined the role of maternal nutritional status in the association between maternal age and small for gestational age (SGA) delivery and birth length. We used data from a birth cohort study in Ethiopia, involving women who were 15-24 years of age and their newborns. A mediation analysis was fitted in a sample of 1,422 mother infant dyads for whom data on birth length were available, and 777 dyads for whom gestational age and birth weight was measured. We used commands, medeff for the mediation analysis and medsens for sensitivity analysis in STATA 14. Maternal nutritional status, measured by mid-upper arm circumference, mediated 21% of the association between maternal age and birth length and 14% of the association with SGA delivery. The average direct effect (ADE) of maternal age on birth length was (ß = 0.45, 95% CI [0.17, 0.99]) and the average causal mediated effect (ACME) was (ß = 0.12, 95% CI [0.02, 0.15]). We also found an ADE (ß = 0.31, 95% CI [0.09, 0.47]) and an ACME of (ß = 0.05, 95% CI [0.003, 0.205]) of maternal age on SGA delivery. The sensitivity analysis suggests an unmeasured confounder with a positive correlation of 0.15 and 0.20 between the mediator and the outcome could explain the observed ACME for birth length and SGA, respectively. We cannot make strong causal assertions as the findings suggest the mediator partly explained the total effect of maternal age on both outcomes.

Neither n-3 Long-Chain PUFA Supplementation of Mothers through Lactation nor of Offspring in a Complementary Food Affects Child Overall or Social-Emotional Development: A 2 × 2 Factorial Randomized Controlled Trial in Rural Ethiopia.

BACKGROUND: The n-3 (ω-3) long-chain polyunsaturated fatty acid (LC-PUFA) docosahexaenoic acid (DHA) is essential for optimal brain development. There is a lack of evidence on the effect of postnatal n-3 LC-PUFA supplementation on child development in low-income countries. OBJECTIVE: We evaluated the efficacy of fish-oil supplementation through lactation or complementary food supplementation on the development of children aged 6-24 mo in rural Ethiopia. METHODS: We conducted a double-blind randomized controlled trial of n-3 LC-PUFA supplementation for 12 mo using fish-oil capsules [maternal intervention: 215 mg DHA + 285 mg eicosapentaenoic acid (EPA)] or a fish-oil-enriched complementary food supplement (child intervention: 169 mg DHA + 331 mg EPA). In total, 360 pairs of mothers and infants aged 6-12 mo were randomly assigned to 4 arms: maternal intervention and child control, child intervention and maternal control, maternal and child intervention, and maternal and child control. Primary outcomes were overall developmental performance with the use of a culturally adapted Denver II test that assesses personal-social, language, fine-motor, and gross-motor domains and social-emotional developmental performance using the Ages and Stages Questionnaire: Social Emotional at baseline and at 6 and 12 mo. We used mixed-effects models to estimate intervention effects on developmental performance over time (intervention × time interaction). RESULTS: The evolution in overall and social-emotional developmental performance over time did not differ across study arms (intervention × time: F = 1.09, P = 0.35, and F = 0.61, P = 0.61, respectively). Effects did not change after adjustment for child age, birth order, and nutritional status; maternal age and education; wealth; family size; and breastfeeding frequency. Children's developmental performance significantly decreased during study follow-up (ß: -0.03 SDs/mo; 95% CI: -0.04, -0.01 SD/mo; P < 0.01). CONCLUSIONS: n-3 LC-PUFA supplementation does not affect overall or social-emotional development of children aged 6-24 mo in a low-income setting. Follow-up of the cohort is recommended to determine whether there are long-term effects of the intervention. This trial was registered at clinicaltrials.gov as NCT01817634.

Adolescent pregnancy and linear growth of infants: a birth cohort study in rural Ethiopia.

BACKGROUND: Evidences indicate that the risk of linear growth faltering is higher among children born from young mothers. Although such findings have been documented in various studies, they mainly originate from cross-sectional data and demographic and health surveys which are not designed to capture the growth trajectories of the same group of children. This study aimed to assess the association between young maternal age and linear growth of infants using data from a birth cohort study in Ethiopia. METHODS: A total of 1423 mother-infant pairs, from a birth cohort study in rural Ethiopia were included in this study. They were followed for five time points, with three months interval until the infants were 12 months old. However, the analysis was based on 1378 subjects with at least one additional follow-up measurement to the baseline. A team of data collectors including nurses collected questionnaire based data and anthropometric measurements from the dyads. We fitted linear mixed-effects model with random intercept and random slope to determine associations of young maternal age and linear growth of infants over the follow-up period after adjusting for potential confounders. RESULTS: Overall, 27.2% of the mothers were adolescents (15-19 years) and the mean ± SD age of the mothers was 20 ± 2 years. Infant Length for Age Z score (LAZ) at birth was negatively associated with maternal age of 15-19 years (ß = - 0.24, P = 0.032). However, young maternal age had no significant association with linear growth of the infants over the follow-up time (P = 0.105). Linear growth of infants was associated positively with improved maternal education and iron-folate intake during pregnancy and negatively with infant illness (P < 0.05). CONCLUSION: Young maternal age had a significant negative association with LAZ score of infants at birth while its association over time was not influential on their linear growth. The fact that wide spread socio economic and environmental inequalities exist among mothers of all ages may have contributed to the non-significant association between young maternal age and linear growth faltering of infants. This leaves an opportunity to develop comprehensive interventions targeting for the infants to attain optimal catch-up growth.

Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial.

Micronutrients powder (MNP) can prevent anaemia amongst children 6-23 months old. However, evidence of an effect on growth is limited and concerns about the safety of iron-containing MNP interventions limits their applicability. In a cluster randomized controlled intervention, we evaluated the effectiveness of a nutritional package including counselling and provision of MNP to improve the nutritional status of children aged 6-23 months and the effect of sustained use of MNP on morbidity in a malaria-endemic area. Child feeding practises and nutritional status were assessed through cross-sectional surveys. Biweekly morbidity surveillance and anthropometry measurements were carried out in a nested cohort study. No significant differences in the prevalence of wasting (-0.7% [-6.8, 5.3] points; p = .805), stunting (+4.6% [-2.9, 12.0] points; p = .201), or mean length-for-age z-score and weight-for-length z-score scores were found between study groups. The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively. There were no significant differences in the risk of diarrhoea (RR: 1.68, 95% CI [0.94, 3.08]), fever (RR: 1.20 [0.82, 1.77]), and malaria (RR: 0.68 [0.37, 1.26]) between study groups. In the nested study, the rate of linear growth was higher in the intervention than in the control group by 0.013 SD/month (p = .027). In a programmatic intervention, MNP and nutrition education marginally improved child feeding practises and growth, without increasing morbidity from malaria or fever.

Household food insecurity and its association with school absenteeism among primary school adolescents in Jimma zone, Ethiopia.

BACKGROUND: Household food insecurity and lack of education are two of the most remarkable deprivations which developing countries are currently experiencing. Evidences from different studies showed that health and nutrition problems are major barriers to educational access and achievement in low-income countries which poses a serious challenge on effort towards the achieving Sustainable Development Goals. Evidence on the link between food security and school attendance is very important to address this challenge. This study aimed to assess to what extent food insecurity affects school absenteeism among primary school adolescents. METHODS: A school based cross-sectional study was conducted among primary school adolescents in Jimma zone from October-November, 2013. Structured questionnaire was used to collect data on the household food security and socio-demographic variables. Data were analyzed using SPSS for windows version 16.0 after checking for missing values and outliers. Multivariable logistic regression analyses were used to determine the association of school absenteeism and food insecurity with independent variables using odds ratio and 95 % of confidence intervals. Variables with p ≤ 0.25 in the bivariate analyses were entered into a multivariable regression analysis to control for associations among the independent variables. RESULTS: The frequency of adolescent school absenteeism was significantly high (50.20 %) among food insecure households (P < 0.001) compared to their peers whose households were food secure (37.89 %). Findings of multivariable logistic regression analysis also showed that household food insecurity [AOR = 2.81 (1.70, 4.76)] was positively associated with poor school attendance while female-headed household [AOR = 0.23 (0.07, 0.72)], urban residence [AOR = 0.52 (0.36, 0.81)] and male-gender [AOR = 0.64 (0.54, 0.74)] were inversely associated with school absenteeism. Household food insecurity was positively associated with lack of maternal education [AOR = 2.26 (0.57, 8.93)] and poor household economic status [AOR = 1.39 (1.18, 2.83)]. However, livestock ownership [AOR = 0.17 (0.06, 0.51)] was negatively associated with household food insecurity. CONCLUSIONS: Findings of this study showed that household food insecurity has strong linkage with adolescent school absenteeism. Maternal education and household economic status were significantly associated with household food security status. Therefore, national policies and programs need to stress on how to improve family income earning capacity and socioeconomic status to handle household food insecurity which is a key contributor of adolescent school absenteeism.

Urban-rural disparities in the nutritional status of school adolescent girls in the Mizan district, south-western Ethiopia.

INTRODUCTION: Malnutrition that occurs during adolescence has important consequences for the future growth and development of the individual, particularly in girls in developing countries. Besides limiting growth, adolescent malnutrition has important consequences for society. Despite this, there is a lack of information on the nutritional status of adolescent girls in Ethiopia. This study was therefore performed to help redress this lack of data and to provide information for future improvements by health planners and policy makers. METHODS: A comparative cross-sectional study design was employed to determine the urban-rural disparity in nutritional status of adolescent school girls in the Mizan district in south-western Ethiopia. A two-stage sampling procedure was used to randomly select 622 adolescent girls, 311 each from urban and rural locations. Trained field workers used structured questionnaires to obtain the desired information from the respondents. Anthropometric measurements of height and weight were collected using standard procedures and appropriate quality control measures. Height-for-age Z-scores and body mass index (BMI)-for-age Z-scores were generated using AnthroPlus software. The independent sample t-test and χ2 test were used to determine statistical significance. RESULTS: There were no significant differences in the ages or physical activities of the two populations of girls studied. Consumption of cereal, vegetables, sweets, sugars, fats, meat, and eggs was similar between the two groups, although slight differences were found with regard to legumes, milk, and fruit consumption. No significant differences were found in the prevalence of mild underweight girls and overweight girls in the urban and rural groups (26.5% vs 22.3% and 7.5% vs 5.2%, respectively). Significant stunting was, however, present in the rural population (40.9% vs. 17.8% in the urban group). Although overall lower than the reference data provided by WHO, the mean BMI-for-age Z-scores and height-for-age Z-scores were significantly higher in the urban girls than in their rural counterparts, with mean differences of 0.18 (95% confidence interval (CI) 0.02-0.34) and 0.58 (95% CI 0.45-0.72), respectively. CONCLUSIONS: Malnutrition was present in both urban and rural adolescent girls. The most obvious disparity between the two populations was significant stunting in the rural population. There is therefore an urgent need for strategies to address severe nutritional problems in rural adolescent girls and to improve the nutrition of adolescent girls within the urban environment.

Corrigendum to 'Defining a Dichotomous Indicator for Population-Level Assessment of Dietary Diversity Among Pregnant Adolescent Girls and Women: ' [Curr. Dev. Nutr. 8 (2024) 102053].

[This corrects the article DOI: 10.1016/j.cdnut.2023.102053.].

Defining a Dichotomous Indicator for Population-Level Assessment of Dietary Diversity Among Pregnant Adolescent Girls and Women: A Secondary Analysis of Quantitative 24-h Recalls from Rural Settings in Bangladesh, Burkina Faso, India, and Nepal.

Background: The Minimum Dietary Diversity for Women of Reproductive Age (MDD-W) indicator was validated as a proxy of micronutrient adequacy among nonpregnant women in low- and middle-income countries (LMICs). At that time, indeed, there was insufficient data to validate the indicator among pregnant women, who face higher micronutrient requirements. Objective: This study aimed to validate a minimum food group consumption threshold, out of the 10 food groups used to construct MDD-W, to be used as a population-level indicator of higher micronutrient adequacy among pregnant women aged 15-49 y in LMICs. Methods: We used secondary quantitative 24-h recall data from 6 surveys in 4 LMICs (Bangladesh, Burkina Faso, India, and Nepal, total n = 4909). We computed the 10-food group Women's Dietary Diversity Score (WDDS-10) and calculated the mean probability of adequacy (MPA) of 11 micronutrients. Linear regression models were fitted to assess the associations between WDDS-10 and MPA. Sensitivity, specificity, and proportion of individuals correctly classified were used to assess the performance of MDD-W in predicting an MPA of >0.60. Results: In the pooled sample, median values (interquartile range) of WDDS-10 and MPA were 3 (1) and 0.20 (0.34), respectively, whereas the proportion of pregnant women with an MPA of >0.60 was 9.6%. The WDDS-10 was significantly positively associated with MPA in each survey. Although the acceptable food group consumption threshold varied between 4 and 6 food groups across surveys, the threshold of 5 showed the highest performance in the pooled sample with good sensitivity (62%), very good specificity (81%), and percentage of correctly classified individuals (79%). Conclusions: The WDDS-10 is a good predictor of dietary micronutrient adequacy among pregnant women aged 15-49 y in LMICs. Moreover, the threshold of 5 or more food groups for the MDD-W indicator may be extended to all women of reproductive age, regardless of their physiologic status.