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Obesity, Childhood clinical trials

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NCT ID: NCT04597281 Recruiting - Obesity, Childhood Clinical Trials

MEditerranean LIfestyle in Pediatric Obesity Prevention

MELI-POP
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The current project is a randomized controlled multi-centre clinical trial, in a cohort of children aged 3 to 6 years at baseline and being at obesity risk. The main objective consists on assessing the efficacy of an intervention during early childhood, considering a healthy lifestyle based on the promotion of a Mediterranean dietary pattern and regular physical activity, compared with a control group, on decreasing obesity incidence 5 and 10 years after the beginning of the intervention. It is envisaged to include 738 children, aged 3 to 6 years, having at baseline a body mass index (BMI) < than the equivalent to 30 kg/m2 in adults, and at least one parent having a BMI > 25 kg/m2. The clinical trial will have two arms and will be performed in Primary Health centres in 3 cities: Córdoba, Santiago de Compostela and Zaragoza. The control group will receive usual care by healthcare professionals. The intervention group, will receive education on Mediterranean lifestyle (Mediterranean diet and physical activity promotion), combined with the provision of extra-virgin olive oil and fish, in order to be consumed at least 3 times per week. Physical activity sessions with a physical activity monitor will also be offered for free to the children (2 sessions of 60 minutes of moderate-vigorous physical activity, per week). The participants' degree of compliance with the intervention will be periodically monitored. The main outcome is the incidence of obesity and the secondary outcomes are changes in body composition, physical fitness and cardiovascular risk factors. We are targeting for a 10 year follow-up.

NCT ID: NCT04578652 Recruiting - Insulin Resistance Clinical Trials

Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance [IR]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM. .

NCT ID: NCT04476160 Recruiting - Insulin Resistance Clinical Trials

Effectiveness of Cinnamon on Insulin Resistance ( ECIRCCOS ) December 1, 2019

ECIRCCOS
Start date: November 12, 2019
Phase: N/A
Study type: Interventional

Childhood obesity is one of the most serious public health problems of the 21st century. It is considered that if there are no changes in prevention and treatment strategies there will be an increase to 70 million obese children by 2025. Of the only pharmacological treatments accepted at this age to improve insulin resistance is metformin, but it can condition gastrointestinal, muscular and hepatic adverse events. Cinnamon is an alternative therapy, which due to its high concentrations of polyphenols, improves insulin resistance by decreasing the proinflammatory environment that occurs in this group of patients, and unlike metformin with less frequent adverse events. The effectiveness of cinnamon has been demonstrated by decreasing insulin resistance in the adult population.

NCT ID: NCT04451148 Recruiting - Metabolic Syndrome Clinical Trials

Gut Microbiome and Obesity

MATOMS
Start date: May 1, 2020
Phase:
Study type: Observational

Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.

NCT ID: NCT04411511 Recruiting - Covid-19 Clinical Trials

COVID-19, Obesity and Lifestyle in Children

COLC
Start date: May 6, 2020
Phase:
Study type: Observational

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.

NCT ID: NCT04185753 Recruiting - Clinical trials for Cardiovascular Risk Factor

Chronotropic Incompetence During Exercise Testing in Obese Adolescents

Start date: November 29, 2019
Phase:
Study type: Observational

In adolescents with obesity cardiopulmonary exercise testing (CPET) has become an important clinical examination providing valuable information with regard to the integrative exercise responses, including the pulmonary, cardiovascular and muscular systems. During CPET, mechanical constraints in ventilation, an elevated risk for hypoxia and chronotropic incompetence (CI) (defined as the inability of the heart to increase its rate with increased activity), or compromised cardiac function (e.g. lowered heart rate (HR) recovery, chronotropic index and stroke volume) are often observed in obese adults. Moreover, several studies regarding exercise capacity and cardiopulmonary responses to maximal endurance exercise testing have been performed in obese adolescents. Despite these previous investigations in obese adolescents it remains controversial whether cardiopulmonary disturbances can be observed consistently during CPET. However, a number of studies have reported a suboptimal response to exercise, in particular a reduced peak heart rate (HRpeak) and peak cycling power output (Wpeak). Adult obesity modifies cardiac behavior, including resting HR and CI, which has a marked effect on exercise capacity. Therefore, chronotropic variables are the most important factors that affect exercise performance. It has been shown that both peak and resting HR account for over forty percent of variability of exercise capacity. Interestingly, resting HR and HR response to exercise, including a blunted HR increase, low chronotropic index and HR recovery, are important predictors of all-cause mortality and cardiovascular death, at least in adults. These changes in HR during and recovery from CPET are mediated by the balance between sympathetic and vagal activity of the autonomic nervous system. Adverse cardiovascular outcomes associated with the metabolic syndrome may be mediated by autonomic dysfunction, whereby obesity is characterized by sympathetic predominance and a decrease in vagal activity in the basal state, where reduced sympathetic responsiveness has been observed during exercise. Therefore, these multiple exercise risk markers could provide valuable clinical information regarding cardiometabolic health. Nonetheless HR behavior during CPET has not been described in obese adolescents. The goal of this study is to examine the HR behavior of obese adolescents during CPET to clarify whether this population suffer from CI.

NCT ID: NCT04177472 Recruiting - Parenting Clinical Trials

Mothers And careGivers Investing in Children

MAGIC
Start date: November 14, 2019
Phase: N/A
Study type: Interventional

The incidence of childhood obesity in the United States has steadily increased over the past 30 years but has begun to level off in recent years. Epidemiological evidence indicates that obesity may transmitted across multiple generations. The current study seeks to: 1) evaluate the extent to which grandmothers or other important caregivers affect their mothers' parenting surrounding feeding their child, and 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time.

NCT ID: NCT04143074 Recruiting - Obesity Clinical Trials

Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"

Start date: April 1, 2011
Phase: N/A
Study type: Interventional

"6-10-14 for Health" is an integrated weight-loss intervention programme for obese children from Gdansk municipality. Both participants of the programme and their family members are offered a 12-month integrated intervention, including medical, dietetic and psychological counselling, as well as educational workshops for parents.

NCT ID: NCT04057716 Recruiting - Sleep Clinical Trials

Project REST: Regulation of Eating and Sleep Topography

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

Overweight/obesity and inadequate sleep are prevalent, and frequently co-occurring, health risks among children, both of which are associated with serious medical and psychosocial health complications including risk for cardiovascular disease. Although the investigator's data suggest that disrupted or shortened sleep may be causally associated with increased energy intake and weight gain in children, and with self-regulation and neural response to food cues in adults, understanding of mechanisms involved in the sleep/eating association is incomplete, thereby impeding development of targeted, optimally timed intervention strategies. The proposed mechanistic clinical trial aims to assess the effects of an experimental sleep manipulation on eating-related self-regulation and its neural substrates, and on real-world eating behavior, among children with overweight/obesity, which will help guide research efforts towards the refinement of prevention and intervention strategies targeting sleep and its eating-related correlates to curb weight gain throughout development.

NCT ID: NCT03994029 Recruiting - Obesity, Childhood Clinical Trials

Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Start date: July 4, 2021
Phase: N/A
Study type: Interventional

The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy