Factors associated with nutrition intervention adherence: Evidence from a cluster-randomised controlled trial in Kenya.

Nutrition experts point to the importance of a multipronged approach to address high stunting rates in rural areas. This can include nutrition-specific and -sensitive interventions, such as the provision of micronutrient powder, eggs, and chlorine, and nutrition training to improve feeding practices. In 2018, an agricultural nongovernmental organisation initiated a multipronged approach as part of a randomised trial. However, adherence to a programme with so many components can be challenging for participants. The aim of this study is to understand which factors are associated with high adherence in complex multifaceted nutrition-sensitive agricultural programmes. We used a mixed method approach in which we used bivariate and multivariable analyses to estimate the relationship between child and caregiver demographic factors with product adherence. We analyzed data from six focus groups and 120 feedback sessions on barriers to product adherence. We found that the age and sex of the child did not influence product adherence, but caregivers were more likely to adhere to all products if they were not the child's biological mother (most often grandmothers) (0.28 higher adherence score; p < 0.001) and if caregivers were older (0.34 higher adherence score, p < 0.001). A higher monthly training attendance, combining product distribution and interactive training, predicted stronger product adherence. Participants noted that adherence was supported by the early demonstration of positive results, regular reminders, interactive trainings, and the encouragement of family members. These findings underscore the importance of combining product distribution with training and include potentially targeting grandmothers and other caregivers who may demonstrate higher product adherence.

Effectiveness of an integrated agriculture, nutrition-specific, and nutrition-sensitive program on child growth in Western Kenya: a cluster-randomized controlled trial.

BACKGROUND: Stunting rates remain unacceptably high in many regions, including sub-Saharan Africa. Agricultural programs have led to increased yields and household incomes but showed limited success in improving nutritional status. OBJECTIVES: We assessed whether linear growth could be improved through a potentially scalable, integrated program adding nutrition-specific and nutrition-sensitive components to an existing agricultural program. METHODS: In this cluster-randomized controlled trial in rural Western Kenya, we randomized children aged 6-35 months from farming families to an agricultural intervention without (control group) or with a bundle of interventions (intervention group), including distribution of micronutrient powders (MNP), poultry to increase egg consumption, seeds of greens and onions, and soap and chlorine solution, as well as provision of monthly behavior change trainings. The primary outcome was the change in height-for-age z-score (HAZ) over 2 years of follow-up. We assessed safety through active morbidity and passive adverse event monitoring. We conducted an intention-to-treat analysis, followed by per-protocol and prespecified subgroup analyses. RESULTS: From March to April 2018, we enrolled 1927 children from 126 clusters (control, 942 children in 63 clusters; intervention, 985 children in 63 clusters). Data on HAZ were available for 1672 (86.6%) children after 2 years. Adherence was >80% for use of MNP, chlorine, and greens and receipt of soap, and ∼40% for egg and red onion consumption. The intention-to-treat analysis indicated a greater change in HAZ over 2 years in the intervention group (adjusted effect size, 0.11; 95% CI: 0.02-0.19). We found a slightly stronger effect in the per-protocol analysis (adjusted effect size, 0.15; 95% CI: 0.06-0.24). Dietary diversity and consumption of iron-rich foods were improved in the intervention group, and reported instances of fever, lower respiratory tract infections, and diarrheal episodes were lower in the intervention group. CONCLUSIONS: This study found a modest improvement in linear growth, indicating the need for multiple, integrated interventions to achieve benefits. The trial was registered with clinicaltrials.gov as NCT03448484.

Characteristics that modify the effect of small-quantity lipid-based nutrient supplementation on child anemia and micronutrient status: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Small-quantity lipid-based nutrient supplements (SQ-LNSs) have been shown to reduce the prevalence of child anemia and iron deficiency, but effects on other micronutrients are less well known. Identifying subgroups who benefit most from SQ-LNSs could support improved program design. OBJECTIVES: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child hemoglobin (Hb), anemia, and inflammation-adjusted micronutrient status outcomes. METHODS: We conducted a 2-stage meta-analysis of individual participant data from 13 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 15,946). We generated study-specific and subgroup estimates of SQ-LNSs compared with control, and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine potential study-level effect modifiers. RESULTS: SQ-LNS provision decreased the prevalence of anemia (Hb < 110 g/L) by 16% (relative reduction), iron deficiency (plasma ferritin < 12 µg/L) by 56%, and iron deficiency anemia (IDA; Hb < 110 g/L and plasma ferritin <12 µg/L) by 64%. We observed positive effects of SQ-LNSs on hematological and iron status outcomes within all subgroups of the study- and individual-level effect modifiers, but effects were larger in certain subgroups. For example, effects of SQ-LNSs on anemia and iron status were greater in trials that provided SQ-LNSs for >12 mo and provided 9 (as opposed to <9) mg Fe/d, and among later-born (than among first-born) children. There was no effect of SQ-LNSs on plasma zinc or retinol, but there was a 7% increase in plasma retinol-binding protein (RBP) and a 56% reduction in vitamin A deficiency (RBP < 0.70 µmol/L), with little evidence of effect modification by individual-level characteristics. CONCLUSIONS: SQ-LNSs can substantially reduce the prevalence of anemia, iron deficiency, and IDA among children across a range of individual, population, and study design characteristics. Policy-makers and program planners should consider SQ-LNSs within intervention packages to prevent anemia and iron deficiency.This trial was registered at www.crd.york.ac.uk/PROSPERO as CRD42020156663.

Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh.

Background: Anemia in young children is a global health problem. Risk factors include poor nutrient intake and poor water quality, sanitation, or hygiene. Objective: We evaluated the effects of water quality, sanitation, handwashing, and nutrition interventions on micronutrient status and anemia among children in rural Kenya and Bangladesh. Design: We nested substudies within 2 cluster-randomized controlled trials enrolling pregnant women and following their children for 2 y. These substudies included 4 groups: water, sanitation, and handwashing (WSH); nutrition (N), including lipid-based nutrient supplements (LNSs; ages 6-24 mo) and infant and young child feeding (IYCF) counseling; WSH+N; and control. Hemoglobin and micronutrient biomarkers were measured after 2 y of intervention and compared between groups using generalized linear models with robust SEs. Results: In Kenya, 699 children were assessed at a mean ± SD age of 22.1 ± 1.8 mo, and in Bangladesh 1470 participants were measured at a mean ± SD age of 28.0 ± 1.9 mo. The control group anemia prevalences were 48.8% in Kenya and 17.4% in Bangladesh. There was a lower prevalence of anemia in the 2 N intervention groups in both Kenya [N: 36.2%; prevalence ratio (PR): 0.74; 95% CI: 0.58, 0.94; WSH+N: 27.3%; PR: 0.56; 95% CI: 0.42, 0.75] and Bangladesh (N: 8.7%; PR: 0.50; 95% CI: 0.32, 0.78; WSH+N: 7.9%, PR: 0.46; 95% CI: 0.29, 0.73). In both trials, the 2 N groups also had significantly lower prevalences of iron deficiency, iron deficiency anemia, and low vitamin B-12 and, in Kenya, a lower prevalence of folate and vitamin A deficiencies. In Bangladesh, the WSH group had a lower prevalence of anemia (12.8%; PR: 0.74; 95% CI: 0.54, 1.00) than the control group, whereas in Kenya, the WSH+N group had a lower prevalence of anemia than did the N group (PR: 0.75; 95% CI: 0.53, 1.07), but this was not significant (P = 0.102). Conclusions: IYCF counseling with LNSs reduced the risks of anemia, iron deficiency, and low vitamin B-12. Effects on folate and vitamin A varied between studies. Improvements in WSH also reduced the risk of anemia in Bangladesh but did not provide added benefit over the nutrition-specific intervention. These trials were registered at clinicaltrials.gov as NCT01590095 (Bangladesh) and NCT01704105 (Kenya).

A behaviour change intervention with lipid-based nutrient supplements had little impact on young child feeding indicators in rural Kenya.

Poor infant and young child feeding (IYCF) practices are associated with linear growth faltering. Our objective was to evaluate the impact of a nutrition and water and sanitation for health intervention on three IYCF indicators-minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD) in Kenyan children. Households were randomized into one of eight groups: (a) active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH + N. In the N and WSH + N arms, community-based promoters counselled households on optimal IYCF practices, and small-quantity lipid-based nutrient supplements (SQ-LNS) were provided to children 6-24 months of age. Twelve months (Year 1) and 24 months (Year 2) after interventions began, enumerators surveyed mothers to ascertain IYCF practices. We made pairwise comparisons of each intervention arm versus the active control arm using log binomial models. In total, 3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2. Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH + N arm (N: 68%; WSH + N: 61%; C: 61%; N arm prevalence ratio: 1.13 95% CI [1.01, 1.25]). In this setting, a nutrition behaviour change communication intervention had little impact on IYCF indicators. The provision of SQ-LNS was not detrimental to current IYCF indicators in the community.

Sickle Cell and α+-Thalassemia Traits Influence the Association between Ferritin and Hepcidin in Rural Kenyan Children Aged 14-26 Months.

Background: The relation between subclinical hemoglobinopathies and concentrations of the iron-regulatory hormone hepcidin is not well characterized. Objective: We investigated the relation of hepcidin concentration with hemoglobinopathies among young children in Kenya. Methods: We quantified serum hepcidin and ferritin in 435 Kenyan children aged 14-20 mo in a subsample of the Water, Sanitation, and Handwashing (WASH) Benefits Trial. Blood samples were genotyped for α+-thalassemia and for sickle cell disorder. Hepcidin was compared across sickle cell and α+-thalassemia genotypes separately by using generalized linear models, and children who were normozygous for both conditions were also compared with those who had either of these conditions. In the association between hepcidin and ferritin, we assessed effect modification by genotype. Results: In this population, we found that 16.2% had sickle cell trait and 0.2% had sickle cell disorder, whereas 40.0% were heterozygous for α+-thalassemia and 8.2% were homozygous. Hepcidin concentration did not differ by genotype, but effect modification was found by genotype in the association between hepcidin and ferritin (P < 0.1). Among normozygous sickle cell children (HbAA), there was an association between hepcidin and ferritin (ß = 0.92; 95% CI: 0.72, 1.10). However, among those with sickle cell trait (HbAS), the association was no longer significant (ß = 0.31; 95% CI: -0.04, 0.66). Similarly, among children who were normozygous (αα/αα) or heterozygous (-α/αα) for α+-thalassemia, hepcidin and ferritin were significantly associated [ß = 0.94 (95% CI: 0.68, 1.20) and ß = 0.77 (95% CI: 0.51, 1.03), respectively]; however, in children who were homozygous for α+-thalassemia (-α/-α), there was no longer a significant association (ß = 0.45; 95% CI: -0.10, 1.00). Conclusion: Hepcidin was not associated with hemoglobin genotype, but there may be a difference in the way hepcidin responds to iron status among those with either sickle cell trait or homozygous α+-thalassemia in young Kenyan children. This trial was registered at clinicaltrials.gov as NCT01704105.

Infant Serum and Maternal Milk Vitamin B-12 Are Positively Correlated in Kenyan Infant-Mother Dyads at 1-6 Months Postpartum, Irrespective of Infant Feeding Practice.

Background: Vitamin B-12 is an essential nutrient required for many functions including DNA synthesis, erythropoiesis, and brain development. If maternal milk vitamin B-12 concentrations are low, infants may face elevated risks of deficiency when exclusively breastfed. Objective: We evaluated cross-sectional associations between infant serum vitamin B-12 concentrations and maternal milk vitamin B-12 concentrations at 1-6 mo postpartum among an unsupplemented population in rural western Kenya, and assessed biological demographic, and dietary characteristics associated with adequate infant serum vitamin B-12. Methods: We modeled 1) infant serum vitamin B-12 using maternal milk vitamin B-12 concentration with linear regression; and 2) adequate (>220 pmol/L) infant serum vitamin B-12 using hypothesized biological, demographic, and dietary predictors with logistic regression. In both models, we used generalized estimating equations to account for correlated observations at the cluster-level. Results: The median (quartile 1, quartile 3) infant serum vitamin B-12 concentration was 276 pmol/L (193, 399 pmol/L) and approximately one-third of infants had serum vitamin B-12 ≤220 pmol/L, indicating that they were vitamin B-12 depleted or deficient. There was a positive correlation between maternal milk and infant serum vitamin B-12 (r = 0.36, P < 0.001) and in multivariable analyses, maternal milk vitamin B-12 concentration was significantly associated with infant serum vitamin B-12 adequacy (P-trend = 0.03). Conclusions: Despite a high prevalence (90%) of maternal milk vitamin B-12 concentrations below the level used to establish the Adequate Intake (<310 pmol/L), there was a low prevalence of infant vitamin B-12 deficiency. We found few factors that were associated with infant vitamin B-12 adequacy in this population, including infant feeding practices, although maternal vitamin B-12 status was not measured. The contribution of maternal milk to infant vitamin B-12 status remains important to quantify across populations, given that maternal milk vitamin B-12 concentration is modifiable with supplementation. This trial was registered at clinicaltrials.gov as NCT01704105.

Vitamin B-12 Concentrations in Breast Milk Are Low and Are Not Associated with Reported Household Hunger, Recent Animal-Source Food, or Vitamin B-12 Intake in Women in Rural Kenya.

BACKGROUND: Breast milk vitamin B-12 concentration may be inadequate in regions in which animal-source food consumption is low or infrequent. Vitamin B-12 deficiency causes megaloblastic anemia and impairs growth and development in children. OBJECTIVE: We measured vitamin B-12 in breast milk and examined its associations with household hunger, recent animal-source food consumption, and vitamin B-12 intake. METHODS: In a cross-sectional substudy nested within a cluster-randomized trial assessing water, sanitation, hygiene, and nutrition interventions in Kenya, we sampled 286 women 1-6 mo postpartum. Mothers hand-expressed breast milk 1 min into a feeding after 90 min observed nonbreastfeeding. The Household Hunger Scale was used to measure hunger, food intake in the previous week was measured with the use of a food-frequency questionnaire (FFQ), and vitamin B-12 intake was estimated by using 24-h dietary recall. An animal-source food score was based on 10 items from the FFQ (range: 0-70). Breast milk vitamin B-12 concentration was measured with the use of a solid-phase competitive chemiluminescent enzyme immunoassay and was modeled with linear regression. Generalized estimating equations were used to account for correlated observations at the cluster level. RESULTS: Median (IQR) vitamin B-12 intake was 1.5 µg/d (0.3, 9.7 µg/d), and 60% of women consumed <2.4 µg/d, the estimated average requirement during lactation. Median (IQR) breast milk vitamin B-12 concentration was 113 pmol/L (61, 199 pmol/L); 89% had concentrations <310 pmol/L, the estimated adequate concentration. Moderate or severe hunger prevalence was 27%; the animal-source food score ranged from 0 to 30 item-d/wk. Hunger and recent animal-source food and vitamin B-12 intake were not associated with breast milk vitamin B-12 concentrations. Maternal age was negatively associated with breast milk vitamin B-12 concentrations. CONCLUSION: Most lactating Kenyan women consumed less than the estimated average requirement of vitamin B-12 and had low breast milk vitamin B-12 concentrations. We recommend interventions that improve vitamin B-12 intake in lactating Kenyan women to foster maternal health and child development. The main trial was registered at clinicaltrials.gov as NCT01704105.