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"Child nutrition disorders"
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Effects of microbiota-directed foods in gnotobiotic animals and undernourished children
Childhood malnutrition is accompanied by growth stunting and immaturity of the gut microbiota. Even after therapeutic intervention with standard commercial complementary foods, children may fail to thrive. Gehrig et al. and Raman et al. monitored metabolic parameters in healthy Bangladeshi children and those recovering from severe acute malnutrition. The authors investigated the interactions between therapeutic diet, microbiota development, and growth recovery. Diets were then designed using pig and mouse models to nudge the microbiota into a mature post-weaning state that might be expected to support the growth of a child. These were first tested in mice inoculated with age-characteristic gut microbiota. The designed diets entrained maturation of the children's microbiota and put their metabolic and growth profiles on a healthier trajectory. Science , this issue p. eaau4732 , p. eaau4735 Health-linked microbiota can be used to monitor the effects of potentially therapeutic dietary components on recovery from malnutrition. To examine the contributions of impaired gut microbial community development to childhood undernutrition, we combined metabolomic and proteomic analyses of plasma samples with metagenomic analyses of fecal samples to characterize the biological state of Bangladeshi children with severe acute malnutrition (SAM) as they transitioned, after standard treatment, to moderate acute malnutrition (MAM) with persistent microbiota immaturity. Host and microbial effects of microbiota-directed complementary food (MDCF) prototypes targeting weaning-phase bacterial taxa underrepresented in SAM and MAM microbiota were characterized in gnotobiotic mice and gnotobiotic piglets colonized with age- and growth-discriminatory bacteria. A randomized, double-blind controlled feeding study identified a lead MDCF that changes the abundances of targeted bacteria and increases plasma biomarkers and mediators of growth, bone formation, neurodevelopment, and immune function in children with MAM.
Journal Article
Effect of nutritional education based on the precede-proceed model on improving the growth indicators, knowledge, attitude, and food intake of malnourished children: study protocol for a randomized clinical trial
Background
Malnutrition in children is associated with cognitive delays, learning disorders, and disturbances in growth indicators. Inadequate food intake, bad eating habits, lack of nutritional knowledge, low mother’s education, and poor economic status are among the causes of malnutrition. School children are more at risk of inappropriate eating behaviors, skipping breakfast, consuming unhealthy snacks, and low physical activity. Therefore, the purpose of this study is to investigate the effect of nutritional education on improving growth indicators, knowledge, attitudes, and food intake.
Methods
This parallel-arm, open-label, randomized clinical trial study will be conducted on 254 children aged 7 to 12 with malnutrition, who will be randomly divided into intervention and control groups. Nutrition education will be conducted during 8 weeks of intervention, and each session will last 45 to 60 min. However, the control group will not receive any education. Weight for age, height for age, BMI for age, food intake, and PRECEDE questionnaire items will be accessed before the intervention, 1 month later, and 3 months after the intervention. The PRECEDE questionnaire prioritizes educational needs and includes specific subscales: predisposing factors (knowledge, attitude, self-efficacy), reinforcing factors, enabling factors, and behavioral assessment. We will analyze the data based on the intention-to-treat protocol. Also, linear regression will be conducted to determine the effect of the intervention on the outcomes after adjustment for the confounding factors.
Discussion
Primary school children are at a special age to improve their eating habits, so they are a suitable target for nutrition education interventions to prevent and treat malnutrition. Therefore, the purpose of this research is to determine whether nutrition education can be effective in improving growth indicators and food intake. The results of this intervention can create a new perspective to reduce the prevalence of malnutrition and improve the symptoms caused by it.
Trial registration
IRCT20181111041611N7. Registered on 2023-07-25.
https://www.irct.ir/trial/67548
.
Journal Article
Cluster-randomized trial of the implementation of the Responses to Illness Severity Quantification (RISQ) system in children with acute malnutrition 6 to 59 months of age in Ngouri, Chad: the CRIMSON trial protocol
Background
The Responses to Illness Severity Quantification (RISQ) System is a scientifically developed clinical decision support tool comprised of four parts: (1) a validated 7-item severity of illness score, (2) age-specific documentation forms, (3) context-relevant score-matched recommendations, and (4) implementation programming. Care recommendations, expertly derived from a panel of clinicians extensively experienced in humanitarian contexts, include frequency of observation, consideration of secondary review, inpatient admission, and transfer into/out of advanced inpatient care areas. The RISQ System is to be used as an adjunct to current care practice to aid clinicians in clinical decision-making. The objective of the CRIMSON study is to estimate the effect of implementation of the RISQ System on mortality and processes of care in a nutritional program.
Methods
A cluster randomized trial will compare the RISQ System to usual care. Eligible clusters are community health centers that enroll patients into the Ministry of Health/ALIMA OptiMA acute malnutrition program in the Ngouri district of Chad. Eligible patients are aged 6–59 months with mid-upper arm circumference (MUAC) < 125 mm and/or edema. Participating centers will be allocated in a 1:1 ratio to usual care or the RISQ System. The primary outcome is mortality to the earlier of 60 days after program entry or program discharge. A 14-month baseline period will precede a 14-month intervention period. With a sample of 20,000 patients in 34 centers (assuming an intraclass correlation coefficient of 0.0005, equal-sized clusters, and 1.5% baseline mortality) provides 80% power to detect a 0.5% absolute decrease in mortality using a one-sided alpha of 0.05. Bayesian logistic regression will be used in analyses of the primary outcome.
Discussion
This cluster randomized evaluation of the RISQ System will estimate effect on program mortality as well as provide detailed information on the implementation of a clinical decision support tool in a low-resource humanitarian setting. Improving the precision of clinical determinations about hospitalization could potentially reduce mortality by 30% within nutrition treatment programs.
Trial registration
ClinicalTrials.gov
NCT06123390
. First posted date: 2023–11-08.
Journal Article
Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial
Introduction
High-quality evidence is crucial for guiding effective humanitarian responses, yet conducting rigorous research, particularly randomised controlled trials, in humanitarian crises remains challenging. The TISA (“traitement intégré de la sous-nutrition aiguë”) trial aimed to evaluate the impact of a Water, Sanitation and Hygiene (WASH) intervention on the standard national treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6–59 months. Implemented in two northern Senegalese regions from December 22, 2021, to February 20, 2023, the trial faced numerous challenges, which this paper explores along with the lessons learned.
Methods
The study utilised trial documentation, including field reports, meeting minutes, training plans, operational monitoring data and funding proposals, to retrace the trial timeline, identify challenges and outline implemented solutions. Contributions from all TISA key staff—current and former, field-based and headquarters—were essential for collecting and interpreting information. Challenges were categorised as internal (within the TISA consortium) or external (broader contextual issues).
Results
The TISA trial, executed by a consortium of academic, operational, and community stakeholders, enrolled over 2000 children with uncomplicated SAM across 86 treatment posts in a 28,000 km
2
area. The control group received standard outpatient SAM care, while the intervention group also received a WASH kit and hygiene promotion. Initially planned to start in April 2019 for 12 months, the trial faced a 30-month delay and was extended to 27 months due to challenges like the COVID-19 pandemic, national strikes, health system integration issues and weather-related disruptions. Internal challenges included logistics, staffing, data management, funding and aligning diverse stakeholder priorities.
Discussion and conclusion
Despite these obstacles, the trial concluded successfully, underscoring the importance of tailored monitoring, open communication, transparency and community involvement. Producing high-quality evidence in humanitarian contexts demands extensive preparation and strong coordination among local and international researchers, practitioners, communities, decision-makers and funders from the study’s inception.
Trial registration
Clinicaltrials.gov
NCT04667767
.
Journal Article
The MAL-ED Study: A Multinational and Multidisciplinary Approach to Understand the Relationship Between Enteric Pathogens, Malnutrition, Gut Physiology, Physical Growth, Cognitive Development, and Immune Responses in Infants and Children Up to 2 Years of Age in Resource-Poor Environments
Highly prevalent conditions with multiple and complex underlying etiologies are a challenge to public health. Undernutrition, for example, affects 20% of children in the developing world. The cause and consequence of poor nutrition are multifaceted. Undernutrition has been associated with half of all deaths worldwide in children aged <5 years; in addition, its pernicious long-term effects in early childhood have been associated with cognitive and physical growth deficits across multiple generations and have been thought to suppress immunity to further infections and to reduce the efficacy of childhood vaccines. The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) Study, led by the Fogarty International Center of the National Institutes of Health and the Foundation for the National Institutes of Health, has been established at sites in 8 countries with historically high incidence of diarrheal disease and undernutrition. Central to the study is the hypothesis that enteropathogen infection contributes to undernutrition by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. It is further postulated that this leads to growth faltering and deficits in cognitive development. The effects of repeated enteric infection and undernutrition on the immune response to childhood vaccines is also being examined in the study. MAL-ED uses a prospective longitudinal design that offers a unique opportunity to directly address a complex system of exposures and health outcomes in the community—rather than the relatively rarer circumstances that lead to hospitalization—during the critical period of development of the first 2 years of life. Among the factors being evaluated are enteric infections (with or without diarrhea) and other illness indicators, micronutrient levels, diet, socioeconomic status, gut function, and the environment. MAL-ED aims to describe these factors, their interrelationships, and their overall impact on health outcomes in unprecedented detail, and to make individual, site-specific, and generalized recommendations regarding the nature and timing of possible interventions aimed at improving child health and development in these resource-poor settings.
Journal Article
Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial
Background
The SELEVER study is designed to evaluate the impact of an integrated agriculture–nutrition package of interventions (including poultry value chain development, women’s empowerment activities, and a behavior change communications strategy to promote improved diets and feeding, care, and hygiene practices) on the diets, health, and nutritional status of women and children in Burkina Faso. This paper presents the rationale and study design.
Methods
The impact evaluation involves a cluster randomized controlled trial design that will be implemented in 120 rural communities/villages within 60 communes supported by SELEVER in the Boucle de Mouhoun, Centre-Ouest, and Haut-Bassins regions of Burkina Faso. Communities will be randomly assigned to one of three treatment arms, including: (1) SELEVER intervention group; (2) SELEVER with an intensive WASH component; and (3) control group without intervention. Primary outcomes include the mean probability of adequacy of diets for women and children (aged 2–4 years at baseline), infant and young child feeding practices of caregivers of children aged 0–2 years, and household poultry production and sales. Intermediate outcomes along the agriculture and nutrition pathways will also be measured, including child nutrition status and development. The evaluation will follow a mixed-methods approach, including a panel of child-, household-, community-, and market-level surveys, and data collection points during post-harvest and lean seasons, as well as one year after implementation completion to examine sustainability.
Discussion
To our knowledge, this study is the first to rigorously examine from a food systems perspective, the simultaneous impact of scaling-up nutrition-specific and nutrition-sensitive interventions through a livestock value-chain and community-intervention platform, across nutrition, health, and agriculture domains. The findings of this evaluation will provide evidence to support the design of market-based nutrition-sensitive interventions.
Trial registration
ISRCTN registry,
ISRCTN16686478
. Registered on 2 December 2016.
Journal Article
Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi
Severe acute malnutrition affects 13 million children worldwide and causes 1–2 million deaths every year. Our aim was to assess the clinical and nutritional efficacy of a probiotic and prebiotic functional food for the treatment of severe acute malnutrition in a HIV-prevalent setting.
We recruited 795 Malawian children (age range 5 to 168 months [median 22, IQR 15 to 32]) from July 12, 2006, to March 7, 2007, into a double-blind, randomised, placebo-controlled efficacy trial. For generalisability, all admissions for severe acute malnutrition treatment were eligible for recruitment. After stabilisation with milk feeds, children were randomly assigned to ready-to-use therapeutic food either with (n=399) or without (n=396) Synbiotic2000 Forte. Average prescribed Synbiotic dose was 10
10 colony-forming units or more of lactic acid bacteria per day for the duration of treatment (median 33 days). Primary outcome was nutritional cure (weight-for-height >80% of National Center for Health Statistics median on two consecutive outpatient visits). Secondary outcomes included death, weight gain, time to cure, and prevalence of clinical symptoms (diarrhoea, fever, and respiratory problems). Analysis was on an intention-to-treat basis. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN19364765.
Nutritional cure was similar in both Synbiotic and control groups (53·9% [215 of 399] and 51·3% [203 of 396]; p=0·40). Secondary outcomes were also similar between groups. HIV seropositivity was associated with worse outcomes overall, but did not modify or confound the negative results. Subgroup analyses showed possible trends towards reduced outpatient mortality in the Synbiotic group (p=0·06).
In Malawi, Synbiotic2000 Forte did not improve severe acute malnutrition outcomes. The observation of reduced outpatient mortality might be caused by bias, confounding, or chance, but is biologically plausible, has potential for public health impact, and should be explored in future studies.
Department for International Development (DfID).
Journal Article