Childhood Obesity

The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.

PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \<18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.

Eating Better Together is a 6-month pilot program that teaches families about healthy eating and activity and provides home deliveries of fresh fruits and vegetables from a local retail partner.

To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. It will also learn about the safety and long-term adherence of 12-hour TRE, in comparison to calory restricted diet (CRD) . The main questions it aims to answer are: 1. Is the weight-losing effect of 12-hour TRE better than CRD? 2. Is 12-hour TRE easier to adhere to than CRD? Researchers will compare 12-hour TRE to CRD (the primary treatment for obesity) to see if 12-hour TRE works to treat childhood obesity. Participants will: 1. Follow the 12-hour TRE or CRD diet every day for 48 weeks; 2. Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests; 3. Keep a diary of their diet, physical activity, and symptoms

The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.

The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity. The main question it aims to answer is: \- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone? This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only). Participants will be followed for six months.

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

This hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial will assess the impact of integrating population health management (PHM) strategies-text messaging and enrollment in Building Healthy Families (BHF)-for lower-income families with a child with obesity identified through electronic health record (EHR) data. BHF promotes family healthy eating, physical activity, and lifestyle behavior strategies to manage weight. The research team will partner with clinical sites (community health clinics, pediatric clinics, rural hospitals) and Community-Based Organizations (CBOs). Clinical partners will execute data-sharing agreements enabling the research team to identify eligible children and caregivers and conduct outreach via text messaging. CBO partners will deliver BHF and provide de-identified data for program evaluation. Community Implementation Teams (CITs) will complete training, surveys, interviews, learning collaborative activities, fidelity assessments, and time tracking as part of quality improvement. The BHF Action Learning Collaborative will use quarterly sessions and Plan-Do-Study-Act cycles to address recruitment, implementation, sustainability, social determinants of health, and team coordination. The research team will record sessions, conduct direct observations of BHF delivery, and take field notes to assess fidelity and adaptations. Families will be identified through EHR records and mailed a consent and authorization cover letter, postcard, QR code, and intervention information with opt-out options. Those who do not opt out will be randomized to bidirectional text messaging with one-touch response and enrollment opportunities, with or without active outreach (telephone or text) from the local CIT. Enrolled families will complete orientation, baseline assessment, and weekly group sessions with ongoing follow-up. Attendance, body weight, goals, and self-monitoring will be recorded in a CIT data portal. Families will be randomized to receive either simple text reminders or reminders with motivational and skill-building prompts matched to session topics. CITs will also connect families to food assistance programs and local resources. Each CIT will complete two cohorts over two years. The primary outcome is reach; secondary outcomes include session attendance, changes in child BMI-z scores, changes in parent or caregiver weight, and changes in adoption, implementation, and maintenance at the community level.

The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.

Childhood obesity in early life contributes to the development of specific NCDs, i.e. adult obesity. Unhealthy diet and low level of physical activity are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of NCDs. Early preventive measures to improve lifestyle behavior are of utmost importance. The aim of ELIPSE-I is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering total energy intake/total energy expenditure (TEI/TEE) ratio in their children with BMI \>97 centile (ELIPSE-I).

This study looks at how a national school meal program affects the health, well-being, and learning of Danish schoolchildren aged 10 to 15 years. The study is part of the Danish National School Meal Pilot Program (2025-2028), which provides free school meals at selected public schools. Some school classes receive free school meals, while other classes do not and are used for comparison. Children are followed for about 1.5 years. Information is collected before and after the program using simple health measurements, questionnaires about well-being, and age-appropriate cognitive tests. The study also uses information from Danish national registers to better understand the children's background and to study longer-term outcomes related to health, education, and social conditions. In addition, the study examines whether school meal programs are cost-effective by comparing their costs with potential benefits for children and society. The goal of the study is to find out whether free school meals can improve children's health, well-being, and learning, and help reduce social differences.

Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.

Rapid onset Obesity, Hypoventilation, Hypothalamic dysfunction and Autonomic Dysregulation (ROHHAD) is a syndrome named in 2007. The hallmark of the syndrome is the rapid onset obesity and dysregulation of central ventilation. There is little information about the metabolic changes that lead to the rapid onset obesity in these children. The investigators would like to study the metabolic phenotype of these children to understand the disturbances in energy balance that lead to the rapid onset obesity.

Evira is a digital support system newly developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, enabling fast and easy communication with the clinic, parents and the clinicians can easily follow the child's weight development. The purpose of this randomized controlled study is to evaluate the effect of adding Evira to the already locally used life-style treatment of childhood obesity.

Childhood obesity has become a major global public health challenge. Obesity can not only affects children's physical and mental health during childhood but may also persist into adulthood, significantly increasing the risk of cardiovascular disease. Therefore, effective prevention and control of childhood obesity can shift the prevention window forward and promote the prevention of cardiovascular disease. Recently, time-restricted eating (TRE) has gained attention in adult studies for its feasibility, as it involves "time control without calorie restriction," demonstrating weight loss effects comparable to energy restriction and higher feasibility. Here, the investigators designed a school-based cluster randomized controlled trial to investigate the effectiveness of 12-hour TRE in preventing and controlling childhood obesity. Schools were randomly assigned to either the intervention group or the control group, and participants were recruited from each school at the class level, ensuring that each group included at least 690 children. The control group received routine health education, while the intervention group received 12-hour TRE in addition to routine health education. After a 9-month intervention period (one academic year), the two groups will be compared in terms of weight management and childhood obesity prevalence.

The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological, psychological, behavioral and environmental. The main questions it aims to answer are: 1. What are the main risk and protective factors for overweight and obesity in the school environment and in the environments around schools in primary education schools in three states of the Mexican Republic? 2. Is there a relationship between risky eating behaviors and the body mass index of schoolchildren? 3. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the presence of protective factors for overweight and obesity in the school environment and in the environments around schools? 4. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the protective factors for overweight and obesity in the family environment?

The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life.

The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT. Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's: * Diet * Exercise * Sleep * Media use * Quality of life

The PKU-FeeD trial is a cluster-randomized controlled trial conducted in Jinan, Shandong Province, China. This study aims to: 1) Develop and evaluate a digital health-assisted, multidisciplinary intervention for preschool children with obesity, assessing its effectiveness and cost-effectiveness. 2) Investigate how lifestyle-based interventions influence the composition and function of the gut microbiota in obese preschoolers, and elucidate the mechanisms by which these interventions may modulate gut microbiota to affect obesity-related metabolic phenotypes.

The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.

The project is a national, prospective, multicenter, interventional pilot project of early detection of childhood overweight and the prevention of obesity in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of childhood overweight and the prevention of obesity and setting up and testing new methods and implementation into the system of health care.

The goal of this interventional study is to prevent childhood obesity in children aged 6-12 years in Chiba City, Japan. The main questions it aims to answer are: * Does the multi-component intervention for environments around children reduce the BMI z-score of children aged 6-12 years after one and two years? * Does the multi-component intervention for environments around children improve the health-related quality of life (assessed by KIDSCREEN-10) of children aged 6-12 years after one and two years? Researchers will compare school clusters receiving the intervention to control clusters to see if the intervention package promotes healthy eating, increases physical activity, improves health-related quality of life, and reduces obesity prevalence. Participants will: * Attend elementary schools within participating clusters (either the intervention or control group). * Have baseline data collected, with follow-up assessments after one year and two years. * Potentially participate in school-based programs (nutrition education, physical activity promotion) and community-based initiatives (park activation, supermarkets) if in an intervention cluster. * Have their physical activity and dietary behavior assessed through self-report questionnaires.

The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.