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Malnutrition clinical trials

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NCT ID: NCT06287827 Recruiting - Child Malnutrition Clinical Trials

Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research

Start date: February 14, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela. The main question it aims to answer is: What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ <-2 or mid-upper-arm circumference (MUAC) <125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery. Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

NCT ID: NCT06250686 Recruiting - Ovarian Cancer Clinical Trials

Exercise and Nutrition Intervention in Ovarian Cancer

BENITA
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients. The main question it aims to answer is: • Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer? Participants of the IG will undergo: - Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition). - Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points: - Baseline: After surgery and before starting chemotherapy - T1: After chemotherapy (week 19) - T2: After intervention (week 26) The primary outcome is: • 6-minute walk test, 6 months after enrollment (T2)

NCT ID: NCT06250166 Recruiting - Colorectal Cancer Clinical Trials

Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are: 1. What are the current eating trends in colorectal cancer patients? 2. What are the common perceptions of adopting a plant-based diet in colorectal cancer? 3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients? 4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status? Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling. The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.

NCT ID: NCT06242301 Recruiting - Physical Inactivity Clinical Trials

Is a Collective Person-centered Dialogue Intervention for Hospitalised COPD Patients Feasible?

COPE-D
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The aim of this mixed methods trial is to investigate the feasibility of a collective person-centred dialogue (COPE-D) intervention delivered by an interdisciplinary team for a population of patients hospitalised and diagnosed with COPD and their relatives. The main questions it aims to answer are: - The clinical uncertainties: What components of the COPE-D intervention are delivered to the included patients? (The data will be collected from the patient's journal record) - The clinical uncertainties: How acceptable is the COPE-D intervention for the patients, relatives, and the interdisciplinary team? (Answered by patient and relative interviews with a structured interview guide before discharge and 14 days after hospitalisation, and by the interdisciplinary team using focus-group interviews after the intervention enrolment). - The procedural uncertainties: Are the patients willing to engage in the trial? (Estimated by the inclusion rate). The interdisciplinary team will be instructed to deliver and document the COPE-D intervention. The primary focus of COPE-D intervention is to prepare and enhance the patient's and relative's ability to regain their everyday life after discharge. The COPE-D intervention includes a dialogue tool based on a needs assessment, an action plan template, and a patient guide that prepares for discharge. The interdisciplinary team will collaborate with COPD patients and their relatives to: 1. Assess the patient's need for nutrition and physical activity support, both during and after hospitalisation using the dialogue tool. 2. Develop an action plan for nutrition and physical activity support using the action plan template. 3. The interdisciplinary team will provide, adjust, and document the nutritional and physical activity support provided by the action plan. 4. Prior to discharge, patients and their relatives are given a discharge guide with pre-defined questions to ask healthcare professionals, a contact telephone number to the outpatient clinic for follow-up if needed, and information about prescriptions for oral nutritional supplementation.

NCT ID: NCT06214897 Recruiting - Clinical trials for Moderate Acute Malnutrition

Choline to Prevent SAM in Children With MAM

CHOP-MAM
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is: Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?

NCT ID: NCT06175273 Recruiting - Pediatric Cancer Clinical Trials

Pediatric Oncology Nutrition Intervention Trial

POINT
Start date: January 31, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival. The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.

NCT ID: NCT06164925 Recruiting - Malnutrition Clinical Trials

Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application

Start date: December 13, 2023
Phase:
Study type: Observational

This observational study of aims to test whether and how the results of GLIM change when using different approaches and methods to carry out its components.

NCT ID: NCT06164301 Recruiting - Critical Illness Clinical Trials

Value of Early Post Operative Amino Acids in Critically Ill Obstetrics on Recovery Enhancement

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

This is the first trial to assess the early elemental postoperative amino-acid load to meet the protein requirements in the first and second day postoperative to enhance the recovery of critically ill parturient (value on ERAS of critically ill obstetrics)

NCT ID: NCT06154174 Recruiting - Clinical trials for Cognitive Impairment

Choline to Improve Malnutrition and Enhance Cognition

CHIME-SAM
Start date: December 5, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: - Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?

NCT ID: NCT06152848 Recruiting - Malnutrition Clinical Trials

The SAM Project: Science Against Malnutrition Project

Start date: July 24, 2023
Phase:
Study type: Observational

The latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. Considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. The SAM study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.