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Underweight clinical trials

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NCT ID: NCT06309576 Not yet recruiting - Obesity Clinical Trials

Experimental Approach to Test Predictions of Body Weight Regulation Models

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

The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation.

NCT ID: NCT05952076 Active, not recruiting - Underweight Clinical Trials

Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants

Start date: July 3, 2023
Phase: Phase 3
Study type: Interventional

The burden of disease experienced by underweight children is significant, particularly in low- and middle-income countries. Gut dysbiosis, an imbalance in microbial composition, is thought to play a role in nutrient malabsorption leading to underweight infants and failure to thrive. Bifidobacterium longum subspecies infantis (B. infantis) is a commensal bacterial strain important in the breakdown of human milk oligosaccharides (HMOs). A decrease in abundance or absence of B. infantis could lead to inadequate HMO processing, elevating intestinal pH and increasing the risk of pathogen overgrowth. Bi-26 is a B. infantis probiotic strain that is being evaluated in this study for its impact on weight gain and other health outcomes in underweight infants.

NCT ID: NCT05881447 Recruiting - Obesity Clinical Trials

Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa

RenalTWO
Start date: June 21, 2023
Phase:
Study type: Observational

Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.

NCT ID: NCT05793294 Recruiting - Clinical trials for Overweight and Obesity

Child Health, Nutrition and Microbiome Development

CHAMP
Start date: May 10, 2024
Phase:
Study type: Observational [Patient Registry]

Childhood malnutrition is a global public health issue with devastating consequences on the health, well-being, and psychosocial development of children. Emerging evidence suggests that malnourished children have immature gut microbiota compared to age-matched healthy controls and it does not repair even after nutritional interventions. The present study aims to characterize how the gut microbiome develops during the first two years of life in children residing in malnutrition endemic areas of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.

NCT ID: NCT05574842 Completed - Overweight Clinical Trials

The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia

DBM
Start date: October 13, 2022
Phase: N/A
Study type: Interventional

The goal of this cluster randomized controlled trial is to determine the effect of double duty interventions on double burden of malnutrition, dietary diversity score, and frequency of morbidity among secondary school adolescents in Debre Berhan City, Ethiopia. The main aim is to answer the following questions. 1. What is the effect of double duty interventions on double burden of malnutrition among secondary school adolescents? 2. What is the effect of double duty interventions on dietary diversity score among secondary school adolescents? 3. What is the effect of double duty interventions on among secondary school adolescents?

NCT ID: NCT05517395 Completed - Stunting Clinical Trials

The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors

Start date: September 10, 2022
Phase: N/A
Study type: Interventional

The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The sample size to be recruited is 80 participants.

NCT ID: NCT05457712 Not yet recruiting - Clinical trials for Congenital Heart Defects

Nutrition In Preoperative Pediatric Congenital Heart Disease

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Introduction: The use of a nutritional protocols provides the standardization of assessment procedures and the optimization of nutritional status recovery of pre-surgical infants with Congenital Heart Disease (CHD). However, to our knowledge there are no validated instrument for presurgical nutritional support for infants with congenital heart disease (CHD) in Brazil. Objective: Assess the clinical effectiveness of the translated and cross-culturally adapted protocol, Nutritional Pathway for Infants with Congenital Heart Disease before Surgery (Marino et al., 2018), on the weight change of infants with congenital heart disease in two specialized cardiology hospitals in Southern Brazil in partnership with the UK research group that authored the original of protocol. Methods: A randomized, pragmatic clinical trial will be carried out. The sample will consist of children with CHD, between 0-12 months of age, awaiting cardiovascular corrective surgery from the Pediatric Outpatient Clinic in the Institute of Cardiology (IC) and Children's Hospital Santo Antonio of Santa Casa de Misericordia. The previously translated pre-surgical nutritional intervention protocol for infants with congenital heart disease will be compared with current routine nutritional guidelines used in the follow-up services of children with congenital heart disease in these institutions within the national public healthcare, SUS. Intended results: It is expected that the culturally-adapted pre-surgical nutritional support protocol for children with congenital heart disease will be effective in pre-surgical infant weight gain, which will likely improve surgical prognosis and clinical outcomes. And we hope that this protocol will promote the standardization of care, and will provide an empirically-based nutritional intervention that may improve the effectiveness of nutritional recovery in the CHD infants. Furthermore, the results may be used in the formulation of Brazilian guidelines for comprehensive care of children with congenital heart disease.

NCT ID: NCT05346549 Completed - Healthy Clinical Trials

Energy Regulation and Nutritional Status of Children: A Satiation Study

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

This is study among children attending child welfare clinics in Greater Accra Region of Ghana. The investigators want to find out if moderately malnourished children regulate the food energy intake similarly to healthy children, using an established method to assess energy compensation.

NCT ID: NCT05248516 Active, not recruiting - Underweight Clinical Trials

ComPAS Low-WAZ RCT Mali

Start date: September 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ<-3 would benefit from treatment and, if so, what treatment protocol should be used. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population. The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ<-3 will be randomized to one of three study arms. The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ<-3 . The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ <-3, b) mean MUAC of children, c) proportion of children with MUAC < 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ<-3 or HAZ<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.

NCT ID: NCT05077059 Completed - Clinical trials for Overweight and Obesity

Prevalence of Obesity and Overweight in Primary School Children in the Rhein-Neckar Region in Germany

Start date: October 1, 2021
Phase:
Study type: Observational

The study will determine the weight status in primary school children in the Rhein-Neckar Region in Germany and will analyse the development of height and weight in these children during the time of COVID-19 related restrictions by asking parents to provide data from childhood examinations. Additionally, interactions between cognitive abilities and weight-status will be studied.