Effectiveness of locally produced ready-to-use supplementary foods on the prevention of stunting in children aged 6-23 months: a community-based trial from Pakistan.

Undernutrition is a major public health problem in developing countries. Around 40·2 % of children are stunted in Pakistan. This longitudinal study aimed to assess the effectiveness of locally produced ready-to-use supplementary foods in the prevention of stunting by detecting change in of children in intervention v. control arm against the 2006 WHO growth reference. A community-based non-randomised cluster-controlled trial was conducted from January 2018 to December 2020 in the district of Kurram, Khyber Pakhtunkhwa, Pakistan. A total of 80 clusters (each cluster comprising ≈ 250-300 households) were defined in the catchment population of twelve health facilities. Children aged 6-18 months were recruited n 1680. The intervention included a daily ration of 50 g - locally produced ready-to-use-supplementary food (Wawa-Mum). The main outcome of this study was a change in length for age z-score (LAZ) v. WHO growth standards. Comparison between the interventions was by t test and ANOVA. Cox proportional hazard models were used to assess the association between stunting occurrence and the utilisation of locally produced supplement. Out of the total 1680, fifty-one out of the total 1680, 51·1 out of the total 1680 and 51·1 % (n 859) were male. Mean age 13·9 months (sd + 859) were male. Mean age 13·9 months (sd + -4·4). At baseline, 36·9 % (n 618) were stunted. In the intervention group, mean LAZ score significantly increased from -1·13(2·2 sd) at baseline to -0·93(1·8 sd) at 6-month follow-up (P value 0·01) compared with the control group. The incidence rate of stunting in the intervention arm was 1·3 v. 3·4 per person year in the control arm. The control group had a significantly increased likelihood of stunting (Hazard Ratio (HR) 1·7, 95 % CI 1·46, 2·05, P value < 0·001) v. the intervention group. Locally produced ready-to-use supplementary food is an effective intervention for reducing stunting in children below 2 years of age. This can be provided as part of a malnutrition prevention package to overcome the alarming rates of stunting in Pakistan.

Effectiveness of locally produced ready to use supplementary food on hemoglobin, anthropometrics, and plasma micronutrients concentrations of 6 to 23 months age children: a non-randomized community-based trial from Pakistan.

Background: Micronutrient deficiencies including vitamin A, vitamin D, and zinc are highly prevalent in children below 5 years of age in low and -middle-income countries. We aimed to evaluate the effectiveness of ready-to-use Lipid-based Nutrient Supplement-Medium Quantity (LNS-MQ) local name "Wawa-mum" on plasma micronutrient status, hemoglobin concentration and anthropometric measurements. Methods: A community-based non-randomized trial was conducted in the Kurram district of Khyber Pakhtunkhwa from January 2018 to June 2019. A total of 110 children aged 6 to 23 months old were recruited and allocated to the intervention and control arm of the study. A total of 57 children in the intervention arm received a daily ration of 50 g of Wawa-mum, for one year. To assess the impact of the intervention on primary outcome measures, i.e., serum vitamin A, D concentration, plasma zinc, and hemoglobin concentration. Blood samples were collected at baseline and after one year following the intervention. The vitamins concentration in serum were assessed using Enzyme-Linked Immunosorbent Assay (ELISA) and plasma zinc by atomic absorption spectrometry. The hemoglobin concentration was measured by an automated hematology analyzer. A 24-h dietary recall interview was used to assess the nutrient intake adequacy. Multivariate Linear regression models were used to analyze the outcomes while controlling for potential confounders. Results: In the intervention arm, children had on average 6.2 µg/dL (95% CI 3.0-9.3, value of p<0.001) increase in the serum vitamin A concentration, 8.1 ng/mL (95% CI 1.3-14.9, value of p 0.02) increase in serum vitamin D concentration and 49.0 µg/dL (95% CI 33.5-64.5, value of p<0.001) increase in the plasma zinc concentration, and 2.7 g/dL (95% CI 2.0-3.3, value of p<0.001) increase in hemoglobin concentration while adjusted for covariates. An addition, length-for-age z-score (LAZ), weight-for-length z-score (WLZ), weight-for-age z-score (WAZ), and prevalence of undernutrition including stunting, wasting, and underweight were calculated as a secondary outcome to investigate the impact of micronutrients on growth parameters, that has been improved significantly after receiving the Wawa-mum. Conclusion: Wawa-mum (LNS-MQ) is an effective intervention to improve the micronutrient status, hemoglobin concentration, and growth parameters in 6 to 23 months children, which can be scaled up in the existing health system to address the alarming rates of under nutrition in Pakistan and other developing countries. Clinical trial registration: https://doi.org/10.1186/ISRCTN94319790, ISRCTN94319790.

Long-Term Impact of Multiple Micronutrient Supplementation on Micronutrient Status, Hemoglobin Level, and Growth in Children 24 to 59 Months of Age: A Non-Randomized Community-Based Trial from Pakistan.

Cost-effective interventions are needed to address undernutrition, particularly micronutrient deficiencies, which are common in children under the age of five in low- and middle-income countries. A community-based, non-randomized clinical trial was undertaken in the Kurram district of Khyber Pakhtunkhwa from January 2018 to June 2019, to evaluate the effect of locally produced micronutrient powder (local name: Vita-Mixe) on plasma micronutrient status, hemoglobin level, and anthropometric outcomes. Children aged 24-48 months old were recruited and allocated to the intervention and control arm of the study. The enrolled children in the intervention arm received one micronutrient powder (MNP) sachet for consumption on alternate days for 12 months. To assess the impact of the intervention on plasma levels of zinc, vitamin D, vitamin A, and hemoglobin level, blood samples were taken at baseline and after one year following the intervention. The analysis was conducted using Enzyme-Linked Immunosorbent Assay (ELISA), atomic absorption spectrometry, and an automated hematology analyzer. For the impact on growth parameters, the anthropometric assessment was performed using WHO standard guidelines. A 24 h dietary recall interview was used to assess the nutrient intake adequacy. Results showed that in the intervention arm, children had on average a 7.52 ng/mL (95% CI 5.11-9.92, p-value < 0.001) increase in the plasma level of vitamin A, 4.80 ng/mL (95% CI 1.63-7.95, p-value < 0.002) increase in vitamin D levels and 33.85 µg/dL (95% CI 24.40-43.30, p-value < 0.001) increase in the plasma zinc level, as well as a 2.0g/dL (95% CI 1.64-2.40, p-value < 0.001) increase in hemoglobin level. Statistically significant improvement was observed in the weight-for-height z-score (WHZ) (from -1.0 ± 0.88 to -0.40 ± 1.01, p < 0.001) and weight-for-age z-score (WAZ) (from -1.40 ± 0.50 to -1.05 ± 0.49, p < 0.001) in the intervention group compared to the control group. No statistically significant change was observed in the height-for-age z-score (HAZ) in the intervention group (p = 0.93). In conclusion, micronutrient powder supplementation is a cost-effective intervention to improve the micronutrient status, hemoglobin level, and growth parameters in under-five children, which can be scaled up in the existing health system to address the alarming rates of undernutrition in Pakistan and other developing countries.

Effectiveness of nutritional supplementation during the first 1000-days of life to reduce child undernutrition: A cluster randomized controlled trial in Pakistan.

Background: Childhood stunting can start in the womb and continue for two years. Therefore, the first 1000 days of life between a woman's pregnancy and her child's 2nd birthday offer a unique window of opportunity to build healthier and more prosperous futures. Therefore, we aimed to assess the effectiveness of nutritional supplementation during the first 1000-days to reduce the prevalence of stunting in children at 24 months of age. Methods: In this cluster randomized controlled trial, we enrolled women during their pregnancy from two rural districts of Sindh, Pakistan. A cluster was one union council with a population of ∼25000 residents. Out of 29 clusters, we randomly allocated 6 clusters to the intervention and control groups each. Pregnant women received a monthly supply of 5 kg (i.e., 165 grams/day) of wheat soya blend plus (WSB+) during pregnancy and the first six months of their lactation period. In addition, their children received lipid-based nutrient supplement - medium-quantity (LNS-MQ) between 6-23 months of age. The primary outcome was a reduction in the prevalence of stunting in children at 24 months of age. Analysis was an intention to treat. The trial is registered on ClinicalTrial.gov, number NCT02422953. Findings: Two thousand thirty pregnant women (1017 in the intervention group and 1013 in the control group) were enrolled between August 30, 2014, and May 25, 2016. Monthly follow-ups were conducted between October 1, 2014, and October 25, 2018. At 24 months of age, we captured data from 699 (78%) of 892 live births in the intervention group and 653 (76%) of 853 live births in the control group. There was a significant difference in mean length (49.4 cm vs 48.9 cm, p =0.027), weight (3.1 kg vs 3.0 kg, p =0.013), length for age z-scores (-1.2 vs -1.5, p =0.004) and weight for age z-scores (-1.2 vs -1.5, p =0.015) among infants in the intervention compared to control group. At 24 months of age, a significant difference in the prevalence of stunting (absolute difference, 10.2%, 95% CI 18.2 to 2.3, p =0.017) and underweight (absolute difference, 13.7%, 95% CI 20.3 to 7.0, p =0.001) were observed in the intervention as compared to the control group. The prevalence of wasting was not significantly different between the intervention and control groups (absolute difference, 6.9%, 95% CI 14.1 to 0.3, p =0.057). Interpretation: Provision of WSB+ and LNS-MQ during the first 1000-days of life improved child linear growth and reduced stunting in children at 24 months. This study can be scaled-up in similar settings to lower the prevalence of stunting in children under two years of age. Funding: World Food Programme, Pakistan.

Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial.

BACKGROUND: In Pakistan, the prevalence of stunting among children younger than 5 y has remained above WHO critical thresholds (≥30%) over the past 2 decades. OBJECTIVES: We hypothesized that an unconditional cash transfer (UCT) combined with lipid-based nutrient supplement (LNS) and/or social and behavior change communication (SBCC) will prevent stunting among children 6-23 mo of age. METHODS: This was a 4-arm, community-based cluster randomized controlled trial conducted in the district of Rahim Yar Khan, Pakistan. A total of 1729 children (UCT, n = 434; UCT + SBCC, n = 433; UCT + LNS, n = 430; and UCT + LNS + SBCC, n = 432) were enrolled at 6 mo of age and measured monthly for 18 mo until the age of 24 mo. RESULTS: At 24 mo of age, children who received UCT + LNS [rate ratio (RR): 0.85; 95% CI: 0.74, 0.97; P = 0.015) and UCT + LNS + SBCC (RR: 0.86; 95% CI: 0.77, 0.96; P = 0.007) had a significantly lower risk of being stunted compared with the UCT arm. No significant difference was noted among children who received UCT + SBCC (RR: 1.03; 95% CI: 0.91, 1.16; P = 0.675) in the risk of being stunted compared with the UCT arm. The pooled prevalence of stunting among children aged 6-23 mo was 41.7%, 44.8%, 38.5%, and 39.3% in UCT, UCT + SBCC, UCT + LNS, and UCT + LNS + SBCC, respectively. In pairwise comparisons, a significant impact on stunting among children in UCT + LNS (P = 0.029) and UCT + LNS + SBCC (P = <0.001) was noted compared with the UCT arm. CONCLUSIONS: UCT combined with LNS and UCT + LNS + SBCC were effective in reducing the prevalence of stunting among children aged 6-23 mo in marginalized populations. UCT + SBCC was not effective in reducing the child stunting prevalence. This trial was registered at clinicaltrials.gov as NCT03299218.

Effectiveness of Specialized Nutritious Foods and Social and Behavior Change Communication Interventions to Prevent Stunting among Children in Badakhshan, Afghanistan: Protocol for a Quasi-Experimental Study.

Stunting predominantly occurs during the first 1000 days of life and continues to the age of five years. We will aim to assess the effectiveness of specialized nutritious foods (SNF)and social and behavior change communication (SBCC) strategies during the first 1000 days of life to prevent stunting among children in two rural districts of Badakhshan, Afghanistan. This will be a quasi-experimental pre-post study with the control group utilizing qualitative and quantitative methods. Before launching the program, formative research will be conducted on the acceptability, appropriate use and SBCC strategies needed to support the introduction of intervention package. Repeated cross-sectional baseline and endline surveys will be conducted in both the intervention and the control districts. After the formative research and baseline household survey, an intervention focusing on the provision of SNF, targeting pregnant and lactating women and children 6-23 months, and SBCC strategies will be implemented for at least 12 months. The primary outcome will be a reduction in the prevalence of stunting among children under two years in the intervention group compared to the control group. We will aim to compare the intervention and control group between the pre- and post-intervention assessments to isolate the effect of the intervention by difference-in-differences estimates. The program monitoring and evaluation component will examine the quality of implementation, acceptability of intervention, identification of potential barriers and to learn how to enhance the program's effectiveness through ongoing operational improvements. The results will be beneficial to design interventions to prevent stunting within Afghanistan and other low-middle-income countries.

Effectiveness of wheat soya blend supplementation during pregnancy and lactation on pregnancy outcomes and nutritional status of their infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan: a cluster randomized-controlled trial.

PURPOSE: We aimed to assess the effectiveness of wheat soya blend plus (WSBP) provided during pregnancy and lactation on weight gain during pregnancy, reduction of low birthweight (LBW), and improvement in nutritional status in infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan. METHODS: A cluster randomized-controlled trial was conducted in Thatta and Sujawal districts in Pakistan from August 2014 to December 2016. A total of 2030 pregnant women were enrolled in the study. These women and their infants were followed during pregnancy and first 6 months of life. Pregnant women received a monthly ration of 5 kg (i.e., 165 g/day) of WSB + during pregnancy and the first 6 months of their lactation period. RESULTS: There was no difference in weight gain during pregnancy between the intervention and control groups (n = 496, 326.7 g/week 95% CI 315.2-338.1 vs. (n = 507, 306.9 g/week, 95% CI 279.9-333.9 P = 0.192), after adjustment with different factors. The reduction in the prevalence of LBW was not different between intervention and control groups (n = 325, 34.0%, 95% CI 31.7-36.4, vs. (n = 127, 34.3%, 95% CI 27.2-41.5, P = 0.932). Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group. However, no difference was noted on reduction in the risk of stunting among infants at 6 months of age in the intervention and control group (n = 1318 RR 0.91, 95% CI 0.78-1.07, P = 0.253) after adjustment. A significant reduction in anemia was noted (n = 1328 RR 0.94, 95% CI 0.91-0.98, P = 0.002) in infants at 6 months of age in the intervention as compared to the control group in adjusted analysis. CONCLUSIONS: Provision of WSB + during pregnancy and the first 6 months of lactation is effective in reducing the risk of under nutrition and anemia in infants at 6 months of age. This study can potentially guide the government and donor agencies in investing in nutritional programmes, especially for pregnant and lactating women living in vulnerable settings.

Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial.

BACKGROUND: Chronic childhood malnutrition, or stunting, remains a persistent barrier to achieve optimal cognitive development, child growth and ability to reach full potential. Almost half of children under-five years of age are stunted in the province of Sindh, Pakistan. OBJECTIVE: The primary objective of this study was to test the hypothesis that the provision of lipid-based nutrient supplement-medium-quantity (LNS-MQ) known as Wawamum will result in a 10% reduction in risk of being stunted at the age of 24 months in the intervention group compared with the control group. DESIGN: A cluster randomized controlled trial was conducted in Thatta and Sujawal districts of Sindh province, Pakistan. A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study. The unit of randomization was union council and considered as a cluster. A total of 12 clusters, 6 in each study group were randomly assigned to intervention and control group. All children received standard government health services, while children in the intervention group also received 50 grams/day of Wawamum. RESULTS: Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88-0.94, p<0.001) and wasting (RR = 0.78, 95% CI; 0.67-0.92, p = 0.004) as compared to children who received the standard government health services. There was no evidence of a reduction in the risk of underweight (RR = 0.94, 95% CI; 0.85-1.04, p = 0.235) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94-0.99, p = 0.042). The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008). The mean compliance of Wawamum was 60% among children. CONCLUSIONS: The study confirmed that the provision of Wawamum to children 6-23 months of age is effective in reducing the risk of stunting, wasting and anaemia. This approach should be scaled up among the most food insecure areas/households with a high prevalence of stunting to achieve positive outcomes for nutrition and health. This study was registered at clinicaltrials.gov as NCT02422953. Clinical Trial Registration Number: NCT02422953.