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Malnutrition, Child clinical trials

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NCT ID: NCT06441305 Not yet recruiting - Malnutrition, Child Clinical Trials

Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya

R-SWITCH
Start date: June 3, 2024
Phase: N/A
Study type: Interventional

Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment. In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues. The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up. In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.

NCT ID: NCT06425523 Not yet recruiting - Malnutrition Clinical Trials

Transforming Health and Resilience In Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale

THRIVE
Start date: July 2024
Phase: N/A
Study type: Interventional

The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups: - Control group: Mothers will receive Enhanced Usual Care (EUC). - HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening. - HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention. The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess childrens' wellbeing and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.

NCT ID: NCT06414200 Not yet recruiting - Malnutrition, Child Clinical Trials

Nutritional Care After Discharge in Children Term Born-18years Old

NutriCAD
Start date: December 1, 2024
Phase: N/A
Study type: Interventional

The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care. The main question it aims to answer is: To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program

NCT ID: NCT06380504 Not yet recruiting - Malnutrition, Child Clinical Trials

Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

R-SWITCH
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness.

NCT ID: NCT06102473 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers. The main question it aims to answer is: - What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups. - The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education. - The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health. The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete: - Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics - Lunch register - 24-hour dietary recall - Survey of food habits and consumption - Validated food preference questionnaire - Anthropometric measurements (Weight, height, waist circumference, body mass index) - Socioeconomic survey - Participate in a simulated online selection and shopping of food and beverages. To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.

NCT ID: NCT06049680 Not yet recruiting - Malnutrition Clinical Trials

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Start date: May 2024
Phase: Phase 4
Study type: Interventional

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

NCT ID: NCT06010719 Not yet recruiting - Malnutrition, Child Clinical Trials

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

AMOUR
Start date: August 2024
Phase: Phase 4
Study type: Interventional

Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.

NCT ID: NCT05911893 Not yet recruiting - Undernutrition Clinical Trials

the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children

EHCONSGDMC
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.

NCT ID: NCT05890378 Not yet recruiting - Malnutrition, Child Clinical Trials

Integrated Livestock Management for Nutrition in Children Under Five Years of Age in Chad

Start date: July 2023
Phase:
Study type: Observational

The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad.

NCT ID: NCT05792514 Not yet recruiting - Malnutrition, Child Clinical Trials

The Reliable Nutritional Risk Screening Tools

Start date: September 1, 2023
Phase:
Study type: Observational

- assess the subjective global validity and reliability of using The Pediatric Yorkhil Malnutrition Score (PYMs) and merits of using the Screening Tool for Risk on Nutritional status and Growth (STRONGkids) as a nutrition screening tool - correlate it with the severity of their nutritional derangements in comparison to the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP)in hospitalized Egyptian children aged (2-5)years in Assiut University Children Hospital (AUCH).