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Childhood Obesity clinical trials

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NCT ID: NCT04731506 Recruiting - Childhood Obesity Clinical Trials

Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Addressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity, and healthy eating among Latinos/Hispanic (L/H) families living in rural communities is an important priority. This study proposes to use cultural adaptation and implementation science frameworks to evaluate the feasibility of delivering a culturally appropriate family-based childhood obesity (FBCO) program via an automated telephone system (IVR) to L/H families living in rural Nebraska. We will conduct a mixed-methods feasibility trial for L/H families with overweight or obese children. In Aim 1, we will first collaboratively adapt all intervention materials to better fit the rural L/H community profile, including translation of materials to Spanish, inclusion of culturally relevant content and images, and use of health communication strategies to address different levels of health literacy. Then, we will evaluate the cultural relevance, suitability, and usability of the adapted intervention materials and mode of delivery. In Aim 2, we will randomly assign participant dyads (parent and child) to either Family Connections (n=29) or a waitlist standard-care group (n=29) and determine overall study reach, preliminary effectiveness in reducing child BMI z- scores, potential for program adoption, implementation, and sustainability through local health departments (RE-AIM outcomes). We will also evaluate health department perceptions of i-PARIHS constructs (innovation, context, recipient characteristics), and Family Connections participants' view of the intervention (i.e., relative advantage, observability, trialability, complexity, compatibility). In conclusion, the study will answer three important questions: (1) Is a telephone delivered FBCO program in rural Nebraska culturally relevant, usable and acceptable by L/H families? (2) Is a telephone delivered FBCO program effective at reducing BMI z-scores in L/H children living in rural Nebraska? and (3) What real-world institutional and contextual factors influence the impact of the intervention and might affect its potential ability to sustainably engage a meaningful population of L/H families who stand to benefit? This project will generate locally and globally relevant evidence on a culturally appropriate technology-delivered FBCO intervention for L/H families in rural communities.

NCT ID: NCT04724330 Recruiting - Clinical trials for Overweight and Obesity

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

H42/H4U
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

NCT ID: NCT04529889 Recruiting - Childhood Obesity Clinical Trials

GDM and Its Consequences in Mothers and Offsprings

GDMCMO
Start date: February 1, 2012
Phase:
Study type: Observational

Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery.

NCT ID: NCT04491344 Recruiting - Childhood Obesity Clinical Trials

Leipzig Childhood Obesity Study

Start date: January 2002
Phase:
Study type: Observational

The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.

NCT ID: NCT04284670 Recruiting - Childhood Obesity Clinical Trials

The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.

NCT ID: NCT04265794 Recruiting - Childhood Obesity Clinical Trials

A Cluster Randomized Trial of the H2GO! Program

Start date: October 22, 2020
Phase: N/A
Study type: Interventional

This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial [RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants

NCT ID: NCT04196556 Recruiting - Childhood Obesity Clinical Trials

Effectiveness of an Intervention Programme for Childhood Obesity: FAMILIACT

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

Objectives. To assess the effectiveness of a programmed family/group intervention to reduce weight in the treatment of obesity in children 7 to 12 years old in front of usual treatment. Design. Cluster randomized controlled trial, multicenter. Location. Primary health care centers. Participants. Obese children 7 to 12 years old of primary health care centers. Body mass index (BMI) > P 97. Patients give Informed consent. Sampling. Randomized cluster assigned. Assignation unit: primary care center. Analysis unit. Patient (Children and childminder). Size: 280 patients (140 by group). Principal measurements Variables.BMI z score (BMI-SDS) after the 6 month intervention and after 12 -month follow-up. Secondary Measurements Variables. quality of Mediterranean diet, Brief questionnaire of physical activity in children. Brief Physical Activity Assessment Tool (BPAAT) for adults (Parents) , apgar-family questionnaire. sociocultural level., educational level, Gender. Age. BMI parents, family antecedent. Analysis: Primary effectiveness. Initial comparability of groups according to the outcome and confusion variables. Mean differences in z score of BMI with 95% confidence intervals, between groups and generation of a multivariate and multilevel model. Analysis by intention to treat.

NCT ID: NCT04151823 Recruiting - Childhood Obesity Clinical Trials

Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study

POST-OB
Start date: January 7, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. It also wants to determine whether postbiotics supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co‐morbidities. All participants will follow a behaviour (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity. Postbiotics and vitamin D3 will be given orally for four months; patients will be evaluated four months after supplementation and diet-lifestyle intervention and four months after the end of supplementation and after the alone diet-lifestyle intervention with blood testing and echosonography of the liver.

NCT ID: NCT04151758 Recruiting - Childhood Obesity Clinical Trials

Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.

DAMOCLE
Start date: January 7, 2019
Phase: Phase 4
Study type: Interventional

Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.

NCT ID: NCT04047888 Recruiting - Childhood Obesity Clinical Trials

Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development

Start date: January 28, 2019
Phase:
Study type: Observational

The period from conception to 2 years of age ('first 1000 days') has been recognized as a critical period for long-lasting programming effects on later obesity and associated NCD and a window of opportunity to implement intervention for reducing and treating childhood obesity. However, there is a dearth of prospective intervention studies that address this nutritional problem in Jamaica and there are no reports of sustainable intervention. Jamaica is a middle income country in which overweight and obesity in children are also increasing at an alarming rate. The investigators in Jamaica are seeking to provide a more comprehensive knowledge on the link between early life nutrition and later childhood health and to assess the impact of an intervention of infant feeding counselling/education in mothers on growth and body composition in their offspring.