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68 active trials for Obesity, Childhood

In-home Obesity Prevention to Reach Low-income Infants

Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and their infants, to test the effectiveness of delivering obesity prevention as part of their weekly, in-home services. The study will evaluate whether the integration of an obesity prevention enhancement module into existing HVP services, reduces the risk and incidence of obesity and associated risk factors in mothers and infants, compared to the provision of standard home visitation services. The study also focuses on the role of maternal factors (maternal diet, physical activity, food insecurity and feeding practices) and social factors (social network support) as mechanisms operating on infant outcomes.

Start: November 2018

Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function

The investigators aim to assess the relationship between overweight/obesity and decreased cognitive function in adolescents. While this relationship has been seen in past literature, the causal mechanisms are still unclear. Thus, the present study will assess sleep and stigma as possible moderators. As sleep is related to both weight and cognitive abilities it may be an important factor in the relationship between these two variables. Further, people with overweight/obesity have higher risk for stigma experiences which may increase inflammation through chronic stress and elevated cortisol. Because inflammation is theorized to play a role in the relationship between elevated BMI and decreased cognitive function, stigma may be an important moderator. 60 adolescent participants will complete two sleep conditions (adequate and restricted) in a randomized order, each followed by a lab visit during which participants will complete a short cognitive battery. At these visits, participants will also be given a self serve breakfast with a variety of whole and processed food options to further evaluate the relationship between overweight/obesity, sleep, nutritional intake, and cognitive function.

Start: September 2020

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Start: July 2018

OBEAT - Beating Obesity

The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women. Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation. This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.

Start: June 2019

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

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.

Start: November 2019

Group Telehealth Weight Management Visits for Adolescents With Obesity

This pilot study aims to evaluate the feasibility and efficacy of a group telehealth model, compared with a standard multi-disciplinary, individualized, in-clinic weight management model, for treatment of adolescents with obesity.

Start: January 2018

Paediatric Obesity and Cardiovascular Dysfunction

Background Childhood obesity has been related to an impaired cardiovascular structure and function. Aims of this study will be to evaluate early cardiovascular abnormalities in a large population of obese children and adolescents compared with a normal weight counterpart, to investigate the potential association with insulin resistance (IR), serum uric acid (sUA), metabolic syndrome (MetS), plasmatic markers of inflammation and oxidative stress and adipokines, to evaluate changes in cardiovascular dysfunction after 6 and 12 months of a behavioral treatment (isocaloric Mediterranean balanced diet plus daily aerobic physical activity). Subjects and methods This was a single-center case-control study. Eighty obese (OB) subjects (6-16 years) and 20 normal weight (NW) matched controls were consecutively recruited. In the whole population we will perform an anthropometric and a cardiovascular assessment. OB patients will also undergo an OGTT and biochemical evaluations. In the OB group, all these evaluations will be performed at baseline and after 6 (T6) and 12 months (T12) of diet plus aerobic training.

Start: January 2015

GOOD-DAY Trial in Paediatric Obesity

Alongside efforts in public health and policy to reverse the childhood obesity epidemic, medical providers seek to play effective roles in prevention and treatment. Limited interventional studies with effective long-term maintenance of weight loss in children are available. Moreover, interventions should focus on modifying lifestyle, by improving also ludic educational training. In fact, the knowledge, attitudes, behaviors and skills developed through effective health programs may result in a better quality of life and empower children to make correct choices to promote the health of the individual the family and the community. For this reason, in a cohort of obese pediatric subjects with visceral adiposity, the aim of the study is to assess the efficacy of an educational training inspired to Mediterranean diet and based on gamification (as "The Mediterranean Goose") with respect to a conventional treatment on weight loss and improvement of cardio-metabolic risk factors.

Start: October 2017

Eat Healthy for Families

This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.

Start: July 2017

Gut Microbiome and Obesity

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.

Start: May 2020

Community Active and Healthy Families

To address childhood overweight disparities among Latino children in immigrant families a pragmatic effectiveness trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a wait-list control randomized design will be conducted. The hypothesis is that children randomized to Community-AHF will demonstrate a reduction in child body mass index (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with wait-list controls.

Start: April 2022

Pediatric Obesity Related Metabolite Profile and Gut Microbiota

In this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. The main metabolites produced by gut microbiome, short chain fatty acids (SCFAs) will be also analysed. The investigators will analyse the change of gut microbiome composition and metabolites related with weight-loss intervention and the relationship between microbiome composition and metabolites.

Start: June 2018

Teens Committed to Health Through Activity, Relationships, and Good Eating

This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.

Start: August 2018

An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild

The purpose of the WWChild study is to determine the feasibility of assessing the potential impact of parents attendance at WW on their child's weight status and weight related behaviours. The feasibility study will randomly allocate 60 parent participants to either the WW programme (formally Weight Watchers) or to a control arm. Data will be collected from both parent and child at baseline and at three months to explore changes in weight status and weight related behaviours.

Start: January 2020

Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents

Insulin resistance is a common complication of childhood obesity. It is considered to be an important link between adiposity and the risk factor of type 2 diabetes in children. The lifestyle modifications, including a healthy diet, physical activity and weight reduction in obese children and adolescents have been proven effective in type 2 diabetes prevention and management. Although increasing evidence suggests that Mediterranean diet could be associated with decreased risk of metabolic syndrome, diabetes, obesity and atherosclerosis in adults. The importance of this study is to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years. Additionally, the results of the present study will help health professionals particularly dietitians in directing children with insulin resistance towards adopting healthy diet and lifestyle.

Start: February 2020

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

Childhood obesity and metabolic risk are at record high levels in the US, and Latino children are at very high risk. This project will test an intervention called Fit 5 Kids, designed for Latino preschoolers to decrease their screen time in order to promote physical activity and healthy eating, and to prevent obesity. Ultimately, this line of research has the potential to provide an effective program to reduce risk of obesity for Latinos in the Head Start program and other preschool-based settings.

Start: September 2018

Parent Mentor Interventions for Early Childhood Obesity

The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.

Start: January 2018

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients

The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI

Start: February 2016

Cognitive Function and Body Mass Index in Children and Adolescents

The child will complete computerized tasks and paper-pencil test, and will be presented with symbols, letters, or numbers on a computer screen and asked to respond by pressing a button on the computer. Before each task a researcher will explain the instructions of the task and assess if the child needs a break before completing the next task. While the child is completing computerized tasks, the parent/guardian will be asked to fill out paper-pencil questionnaires about the child and to sign a release of medical information form so that we can study how physical markers of health effect cognition.

Start: September 2018

Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents

Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed, according to INPES in 2006, overweight and obesity were affecting 18 % of French children between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese children are likely to develop chronic disease, starting at paediatric age, as cardiovascular or bone diseases, or type 2 diabetes. Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial hypertension and type 2 diabetes development. Obesity, in adults like in children, is associated with vitamin D deficiency. Common explanations for this low serum concentration of 25(OH)D in obese are the sequestration and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore, obese population is at higher risk of developing cardiovascular and metabolic complications. The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit is difficult to cure with classical loading doses. It seems that these patients need higher dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration (daily vs monthly) was never evaluated. Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular system, adipose tissue) and in light of consequence of obesity on these systems, it seems essential to obtain data on vitamin deficit correction in obese children and adolescents and to evaluate bone status of these patients using modern imaging technics (high resolution peripheral quantitative computed tomography, HRpQCT). In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese children and adolescent will allow us for : evaluate vitamin D correction effect by two scheme of administration establish an inventory of vitamin D status in this population Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself on bone, by analysing bone micro-architecture

Start: September 2020