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64 active trials for Childhood Obesity

Feeding My Baby - A National WIC Study

The goal of the study is to be a current examination of infant and toddler feeding practices among families receiving WIC services. It has been more than 10 years since the last study of such feeding practices, and in the interim important changes have taken place in the WIC program, in society, and in the science of nutrition. The study will include exploration of breastfeeding practices and support, more general feeding practices, nutritional intake of infants and toddlers, transitions in infant and toddler feeding practices, early precursors of obesity, and family factors that may influence all of these nutrition-related issues. It will also explore characteristics of the WIC program in selected sites, and how these relate to infant and toddler feeding decisions and practices. This study is important both to update knowledge about the WIC population, and to uncover possible new avenues of inquiry regarding early childhood obesity. Update on November 25, 2020: The WIC ITFPS-2 will now follow participants through child age 9 years. This unprecedented opportunity will provide FNS with a better understanding of the impact of WIC participation on health and nutrition outcomes in childhood.

Start: July 2013

Vanderbilt Childhood Obesity Registry

In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

Start: November 2012

Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (?26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.

Start: September 2019

Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months

This study aims to assess the impact of a home-visiting program, called "Family Spirit Nurture" (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN intervention targets parent feeding practices, young children's diet and physical activity (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early childhood obesity and, consequently, risk for obesity over the life course. The investigators will also explore whether maternal psychosocial factors (stress, depression and substance use), household food/water security and/or constrained physical activity environments moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers; and, children's diets, PA patterns, and weight status. Finally, the investigators will examine how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity and whether social and behavioral interventions can impact infant metabolic health. The investigators evaluation will employ a randomized controlled design, in which both the intervention and comparison condition receive assisted transportation to prenatal and well-baby visits (called "Optimized Standard Care"), and the comparison condition also receives potentially beneficial injury prevention education at 8 assessment visits. Primary Aims: Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24 months postpartum: Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC mothers will be more likely to meet breastfeeding and complementary feeding recommendations and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers. Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2. FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity and reduced screen time/other sedentary activities compared to IPE + OSC children. Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will be closer to zero (the mean age- and sex- specific BMI z-score for the World Health Organization standard reference population) compared to IPE + OSC children. Secondary Aims: Secondary Aim 1. To explore whether maternal psychosocial factors (stress, depression and substance use), and household food/beverage security and/or constrained physical activity environments moderate FSN intervention impacts on: infant and young children's feeding behaviors; and, infant/young children's diets, PA patterns, and weight status. Secondary Aim 2. To explore how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity, and whether social and behavioral interventions can impact infant metabolic health. Aim 2a. At delivery, examine how measures of infant metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids, and c-reactive protein) are a) correlated with maternal biologic measures of metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids, and c-reactive protein) and b) are impacted by sociodemographic, biological and psychosocial characteristics of mothers at baseline (e.g. age, parity, water/food security, BMI, gestational weight gain, gestational diabetes, depression, perceived stress). Hypothesis: Infant biologic measures of metabolic health will be highly correlated with maternal levels of metabolic health at birth and will vary by maternal baseline characteristics. Aim 2b. Between delivery and 12 months postpartum, examine how biologic measures of infant metabolic health change in relation to a) maternal biologic measures of metabolic health, b) sociodemographic, biological and psychosocial characteristics of mothers at baseline, and c) maternal/infant behaviors (e.g. responsive feeding practices, infant diet, introduction of sugar-sweetened beverages, early physical activity, etc.). Hypothesis: Biologic measures of infant metabolic health over the first 12 months of life will begin to diverge from maternal levels; and, infant metabolic health between delivery and 12 months postpartum will vary by maternal baseline characteristics and maternal/infant behaviors across study groups. Aim 2c. Infant metabolic health. Hypothesis: FSN + OSC infants will have better metabolic health (defined by fasting glucose, insulin, leptin, adiponectin, lipid and c-reactive protein levels) at 12 months postpartum compared with IPE + OSC infants.

Start: September 2017

Genetic Predisposition to Food Cue Reactivity in Children

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.

Start: January 2019

Testing Digital Technologies to Help Families Build Healthy Habits

The current study is a randomized pilot trial to test the feasibility of a psychoeducational virtual reality experience to increase motivation for behavior change among children with overweight or obesity.

Start: April 2021

Evaluation of an Online Lifestyle Intervention in Mexican School Children During COVID-19 Pandemic

Introduction: School closures due to the COVID-19 pandemic represent a risk factor for the development of childhood obesity due to the increase in unhealthy behaviors. Online lifestyle interventions in schoolchildren could help to mitigate this problem. However, to date, no randomized controlled trials have been performed to prevent obesity in schoolchildren during the COVID-19 pandemic. The aim of this study is to evaluate the effect of a 4-month online lifestyle intervention on the BMI Z-score of Mexican schoolchildren during the COVID-19 pandemic in an intervention group compared to a control group. Methodology: This is a pilot randomized controlled trial. Schoolchildren from a public elementary school in Hermosillo, Sonora, Mexico will be invited to participate. Participants will be randomized to an intervention group (online lifestyle intervention) or a control group. The intervention will include online sessions of nutrition education and physical activity and nutrition information for parents. The control group will receive a digital brochure with nutrition recommendations at the beginning of the study. The measurements will be performed at baseline and 4 months. The primary outcome will be the BMI Z- score. Secondary outcomes: waist circumference, fat percentage, nutritional knowledge, lifestyle parameters, retention, attendance at the program sessions, and acceptability of the intervention. The difference between groups in changes in the outcomes will be analyzed using an intention to treat analysis. The protocol was approved by the Research Ethics Committee of the University of Sonora Nursing Department (EPM-003-2020). Conclusion: The study will provide the first evidence of the evaluation of online interventions for the prevention of obesity in schoolchildren derived from a Randomized Controlled Trial. This information will be important for the development and implementation of other school-level obesity prevention programs around the world.

Start: February 2021

Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis

This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).

Start: April 2021

Creating Healthy Environments for Chicago Kids

Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects

Start: August 2017

Respiratory Effects of Obesity in Children

In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory system, particularly during exercise; however, it is unclear if this burden reduces exercise tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be misdiagnosed as asthma, placing obese children at risk of unnecessary treatment and potentially a reluctance to exercise explaining reports of low physical activity and fitness levels, which are counterproductive to weight loss. The investigators will examine the respiratory effects of obesity in prepubescent boys and girls, including those with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with prepubescent normal weight boys and girls before and after 1 year. These results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma, and the results could alter interventional approaches for preventing and treating childhood obesity.

Start: April 2017

Family Matters Intervention

The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease childhood obesity and improve child diet quality in children ages 5-8 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).

Start: July 2021

Pilot Testing of Food Images in Children

This is a single, un-replicated visit to the Children's Metabolic Kitchen and Eating Behavior Lab designed to gather data on children's responses to images used in MRI studies. Additionally, a demographic questionnaire for parents will be piloted.

Start: October 2017

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

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.

Start: March 2021

A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity

This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the leading cause of death, obesity. The purpose is to help children and their families develop healthy behaviors to decrease childhood obesity. The short-term goal of this study to develop a prototype of theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal of this study is to sustainably reduce the rates of pediatric obesity and its consequences in rural areas, via behavioral change. It is hypothesized that after participating in this intervention, children will show improvement in age-based body mass index percentile and improved behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors. Additionally, it is hypothesized that parents will show improved attitudes and skills for managing their child's behavior and improved perceived stress and perceived quality of life. Finally, levels of attendance, participation, and technology feasibility will indicate a successful intervention.

Start: April 2021

Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center

Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. The Alternative Learning Center (ALC) within Rochester School District 535 provides viable educational options for students who are experiencing difficulty in regular educational systems. A greater proportion of students at ALC are minorities, qualify for free and reduced lunch and receive special education services. These children are likely to have unique barriers to physical activity and healthy eating. Specific Aims: Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors related to physical activity and eating in ALC students. Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy lifestyle.

Start: November 2014

Plant Stanols and Liver Inflammation in Overweight and Obese Children

Obesity is associated with a variety of co-morbidities. Children with obesity are more likely to have risk factors associated with cardiovascular diseases (CVD) and CVD risk markers (e.g. hypertension, elevated serum cholesterol, and type 2 diabetes mellitus), but also with organ specific pathologies such as a non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is approximately 35%, compared to approximately 8% in general pediatric population, making it a very important health threat in these populations. Successful pharmacological interventions to treat or prevent NASH are not yet available and so far only weight loss has clear benefits. However, it is well known that sustained weight-loss is difficult to achieve on the longer-term. The investigators recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. Moreover, Javanmardi et al. recently demonstrated in a population of adult NAFLD patients, that plasma concentrations of Alanine Transaminase (ALT) were reduced after daily plant sterol consumption (1.6 g/d) for 6 weeks. In this study, the investigators propose to evaluate the effect of consuming soft chews enriched with plant stanol esters (3 grams/day) on ALT concentrations in children with overweight or (morbid) obesity who are at risk of developing NAFLD, in a randomized, placebo-controlled, double blinded study with an intervention period and follow-up period of 6 months. 52 overweight and obese children with elevated ALT concentrations (>39 U/L for boys and >33 U/L for girls) will be included. All children will be randomly allocated to consume control or plant stanol ester enriched soft chews on a daily basis for a period of 6 months. After 12 months there will be an additional blood sample to evaluate whether the 6 months intervention is still effective.

Start: March 2021

A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)

The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.

Start: January 2018

Nutritional Intervention in Acute Lymphoblastic Leukemia

Introduction: Annually 400,000 children are diagnosed with cancer in the world. Approximately 90% live in low/middle-income countries, with survival rates of 10-30%. In Mexico, children and adolescents' hospital admissions for cancer are mainly leukemias (46%), being acute lymphoblastic leukemia (ALL) the most common. Half of ALL patients have an altered nutritional status at the time of diagnosis. Nutritional assessment is performed using conventional anthropometric measures, which are not sensitive to changes in fat-free mass and fat mass (FFM and FFM). Our objective is to evaluate the effect of an individualized food-based nutritional intervention according to the nutritional status, body composition and comorbidities in pediatric patients with ALL. This is a pre-test/post-test clinical trial. Children 2-14 y olds diagnosed with ALL and in the remission stage (4-6 weeks post-diagnosis) will participate. The nutritional status will be evaluated using questionnaires and body composition. The intervention will be a 6 mo individualized food-based nutrition plan changing meal plans every 2 wk; every plan provides 5 interchangeable meals, adapting to personal preferences and symptoms related to antineoplastic treatment (nausea, diarrhea, taste alteration, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the nutritional intervention. Effectiveness of the intervention will be assessed using a paired test dependant on the distribution of the data.

Start: January 2022

Environmental Influences on Early Childhood Obesity

Few treatments have been developed for young children with obesity from diverse backgrounds. The present study will develop and test an intervention designed to improve preschool obesity in Latino children. The intervention will focus on improving eating, activity, and sleep behaviors and the home environment for improved weight status.

Start: March 2017

Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years

Obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. Reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management. to reduce childhood obesity, including school-based multi-component behavioral research in Turkey it has not been demonstrated to parents. The program, which is planned to be carried out and aims to reduce overweight and obesity in children, is a school-based parenting lifestyle intervention involving multiple behaviors. The program includes family visits, game-based physical activity activities with children, healthy eating recommendations and healthy eating activities with parent participation. The program planned to be implemented was developed to evaluate whether healthy preferences and lifestyle intervention reduce obesity. The aim of this study is to make the positive health behaviors permanent in children, to be a guide for combating childhood obesity and to be useful for future research. to be applied to the research, nutrition consists of 10 sessions, physical activity, including issues such as coping with healthy ways with stress Child Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.

Start: March 2020