Clinical Research Directory

The Effect of Exercise With AR Glasses on Metabolic Parameters and Anthropometric Measurements in Obese Adolescents

This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Goggles (AR) on metabolic parameters and anthropometric measurement values in obese children aged 10-19 years. The study will be conducted with children diagnosed with obesity between the ages of 10-19 years who are followed up in the Pediatric Endocrinology Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. According to the sample calculation, a total of 20 obese children aged 10-19 years (AR exercise group=10 and control group=10) will be included in the sample of the study. The data of the study will be collected using the Descriptive Characteristics Form for Obese Children and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Augmented Reality Goggles, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Measurement Device. Ethics committee permission was obtained from "Erciyes University Clinical Research Ethics Committee" and institutional permission was obtained from ERU Health Practice and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study, it is expected that exercise application with AR glasses will improve metabolic parameters and anthropometric measurement values in obese children.

Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity. Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months. In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.

Time Restricted Eating in Childhood Obesity (TRECO)

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

Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study

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 Evira Study: Additional Support During Obesity Treatment

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.

Eat Healthy Grow Healthy Program to Promote Fruit and Vegetable Intake in Preschoolers

The Eat Healthy, Grow Healthy (EatGrow) program is a family-based, fully virtual nutrition education intervention designed to improve fruit and vegetable intake among preschool-aged children. Parents and their children participate together in interactive online lessons over eight weeks, including parent-child cooking, taste-testing, and engaging nutrition education. Recruitment was conducted via schools, but schools are not involved in delivering the program. The study measures changes in children's fruit and vegetable intake and willingness to try new foods, as well as parental nutrition literacy, attitudes, and self-efficacy. Weekly tasks are included for engagement.

Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool

The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home. The primary outcomes are to: * Evaluate the proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating). * Evaluate the proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) during or after treatment. Patients at Martina Childrens Hospital, Stockholm, Sweden, who have been treated with the digi-physical treatment tool will be included and their patient records will be reviewed for eating disorder diagnosis or a disturbed eating behavior.

Weight Status, Resilience, and Quality of Life in Indian Children

A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents. Primary Objective To assess differences in overall resilience (total score of Adolescent Resilience score from ARQ49) between normal-weight and overweight/obese Indian adolescents aged 14-16 years. Secondary Objectives 1. To compare differences in Adolescent Resilience Questionnaire (ARQ49) subscale scores between normal-weight and overweight/obese adolescents. The internal resilience factors assessed by the ARQ49 include confidence, emotional insight, negative cognition, social skills, empathy, and tolerance, while the external resilience factors include family connectedness, family availability, peer connectedness, peer availability, supportive school environment, school connectedness, and community connectedness. 2. To assess differences in internal resilience factors (diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism) between normal-weight and overweight/obese adolescents and to examine parental nutrition knowledge as an external resilience resource and moderator in association analyses. 3. To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents. 4. To examine the associations among resilience, dietary and physical activity behaviors, and PedsQL within the overall sample and within different weight groups, and to evaluate parental nutrition knowledge as a moderator of the relationship between weight status and resilience or health outcomes. Exploratory Objective 5. To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents. Study hypotheses The investigators hypothesized that adolescents with overweight/obesity, compared with their normal-weight peers, would demonstrate lower scores on total resilience (primary outcome), as well as on internal and external resilience indices; report lower diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism; report less frequent health-promoting behaviors (including lower fruit and vegetable intake and fewer days achieving ≥ 60 min/day of moderate-to-vigorous physical activity); and report lower PedsQL scores. Parental nutrition knowledge will not be treated as a between-group outcome; instead, it will be tested as a moderator in association analyses, examining whether parental nutrition knowledge influences the relationship between weight status and resilience or health outcomes. Furthermore, the investigators hypothesized that higher resilience scores would be positively associated with healthier dietary behaviors, greater physical activity participation, and higher PedsQL scores across the overall sample, with these associations expected to hold true within both normal-weight and overweight/obese groups. In addition, analyses involving underweight adolescents will be exploratory and descriptive in nature. We will explore whether underweight adolescents show different levels of resilience, health behaviors, and HRQoL compared with adolescents with normal weight.

Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp. Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve quality of life, and risk factors for type 2 diabetes.

MOVI-OLE! [Open Learning Environments]

This study will evaluate the effectiveness of MOVI-OLE! (Open Learning Environment), a school-based intervention designed to reduce sedentary time and enhance multiple aspects of child development, including cognitive function, physical fitness, body composition, psychological well-being, and student engagement. The intervention combines dynamic classroom furniture with student-centered teaching practices. Additionally, a qualitative component will explore how students, teachers, and families perceive the feasibility and acceptability of implementing MOVI-OLE! in real-world school settings.

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents

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.

Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

The ExAMIN Youth SA study aims to generate new knowledge on the pathophysiology involved in early vascular aging among South African children and to identify early novel biological markers for predicting the subclinical development of hypertension and target organ damage related to cardiovascular disease. This study further implements state-of-the-art biochemical technology to measure a variety of biological markers including multiplex analyses and metabolomics. With the increasing prevalence of childhood hypertension and obesity, this study will be able to address especially behavioural contributors to hypertension development and to subsequently provide a backdrop for school-based primary prevention interventions.

Mountain West Prevention Research Center Core Research Project

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.

Postnatal Exercise to Activate Baby's Brown Fat

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.

Early Life Intervention in Pediatrics Supported by E-health

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).

Integrating Food Rx With Best Feeding Practices With EFNEP

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

School Meals in Denmark

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.

Brain Activation and Satiety in Children 2

Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.

Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic

Objectives: (1) to evaluate the feasibility of innovative school-based interventions on health outcomes (psychological well-being, depressive symptoms, anxiety symptoms, physical activity, sleep duration, and sleep quality) among primary students in the post-COVID-19 pandemic period; (2) to explore children's experience of intervention; (3) to evaluate the effects of innovative school-based (WeJoy + WeHop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children. Method: Two phases of the study will be conducted, including feasibility pilot study and main study. In phase 1, a sample of 40 school children will be recruited from two community centers for feasibility test and semi-structured individual face-to-face interview. In phase 2, a total of 408 school children will be recruited from primary schools in Hong Kong. This study will adopt a 2 two-group pre and post-design. Participants are randomly assigned equally into 1 intervention group (WeJoy+WeHop) and 1 control group (Routine Extra curriculum Activity). Participants will be assessed at baseline and post-intervention. The outcomes are depressive symptoms, physical activities, and sleep quality, using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), the Chinese Version of the International Physical Activity Questionnaire (IPAQ-C), and the Chinese version of the Pittsburgh Sleep Quality Index (PSQI-C). Data analysis: Descriptive and inferential statistics will be performed to examine the research objectives.

Phentermine's Impact on Treatment in Teens

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.

The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings

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.

Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome

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.

A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment

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.

Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children

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.